Translating a heart disease lifestyle intervention into the community: the South Asian Heart Lifestyle Intervention (SAHELI) study; a randomized control trial

Background South Asians (Asian Indians and Pakistanis) are the second fastest growing ethnic group in the United States (U.S.) and have an increased risk of atherosclerotic cardiovascular disease (ASCVD). This pilot study evaluated a culturally-salient, community-based healthy lifestyle intervention to reduce ASCVD risk among South Asians. Methods Through an academic-community partnership, medically underserved South Asian immigrants at risk for ASCVD were randomized into the South Asian Heart Lifestyle Intervention (SAHELI) study. The intervention group attended 6 interactive group classes focused on increasing physical activity, healthful diet, weight, and stress management. They also received follow-up telephone support calls. The control group received translated print education materials about ASCVD and healthy behaviors. Primary outcomes were feasibility and initial efficacy, measured as change in moderate/vigorous physical activity and dietary saturated fat intake at 3- and 6-months. Secondary clinical and psychosocial outcomes were also measured. Results Participants’ (n = 63) average age was 50 (SD = 8) years, 63 % were female, 27 % had less than or equal to a high school education, one-third were limited English proficient, and mean BMI was 30 kg/m2 (SD ± 5). There were no significant differences in change in physical activity or saturated fat intake between the intervention and control group. Compared to the control group, the intervention group showed significant weight loss (−1.5 kg, p-value = 0.04) and had a greater sex-adjusted decrease in hemoglobin A1C (−0.43 %, p-value <0.01) at 6 months. Study retention was 100 %. Conclusions This pilot study suggests that a culturally-salient, community-based lifestyle intervention was feasible for engaging medically underserved South Asian immigrants and more effective at addressing ASCVD risk factors than print health education materials. Trial registration NCT01647438, Date of Trial Registration: July 19, 2012 Electronic supplementary material The online version of this article (doi:10.1186/s12889-015-2401-2) contains supplementary material, which is available to authorized users.

1. Participants must fast for at least 10 hours before the examination. This restriction applies to all food and beverages (except water), including alcohol. Instruct them to consume dinner at least 10 hours before their scheduled appointment at the clinic. Only water and prescription medications are allowed from dinner until the start of the examination the next morning. Diabetic patients should not take their hypoglycemic medications the morning of the clinic visit; they should bring the morning dose to the clinic to be taken after venipuncture.

Do you plan to be out of this area for an extended period of time (a month or longer) within the next year?
 If no, continue to the next question.  If yes, approximately when will you leave and when will you return? (provide month/year for both)

A. Emergency Contact Information
"Please provide the following information on two people who are familiar with the status of your health AND who could help us contact you, if necessary. If possible, please include one person who lives with you and one who does not." The participant should provide as much information as possible. Assist him/her, if necessary, in obtaining information.

B. Health Care Provider Information
"Please provide the following information about your health care provider."

 "Do you have a clinic, doctor, nurse, or physician's assistant who provides your usual medical care?"
If no, the form is completed. If yes, please provide the following information for this clinic or person (provide name, title, address, telephone number) and then continue to the next question.
 "When were you last seen by this person? "(provide month/year)

 "Would you like us to send your test results to this person?"
If yes, arrange to send a copy of the anthropometry/BP results and Quest lab results, to the physician in one packet when all results are available. All letters mailed should be tracked in the participant recruitment database. Procedure: This is an interviewer-administered form. The participant will be asked to give his/her date of birth, relationship status, racial/ethnic background, religion, and highest educational level achieved.
Ask the participant each question and record his/her answer. For primary language spoken at home, only one answer should be selected. If a participant gives more than one answer, explain to him/her that the form requires that s/he select only one answer. If more than one bubble is selected, the form will be rejected from the database.
Questions: Q1. What is your date of birth?
Eligibility note: Participants must be between 30 and 60 years of age to be eligible. Date will depend on when they are being screened.

Q2. What language will the interview be conducted in?
Please be sure to have the appropriate forms available for the participant.
Q3. What is your gender? Fill in the appropriate circle.

Q4. Where were you born?
Select one of the following:  Bangladesh  India  Nepal  Pakistan.  Sri Lanka  United States  Other (please specify country). Write in space provided.

If born in another country: "how many years have you lived in the United States?"
Record number of years in box provided. 6. What language is primarily spoken in your household? Fill in the appropriate circle. If "other," specify language.
7. In SAHELI, we are tracking spousal pairs. Please ask the participant "Is your spouse or other family member enrolled in SAHELI?" 8. How do you best describe your religion? Please mark all that apply. 9. What is the highest degree or level of school you have completed? Fill in the appropriate circle. If currently enrolled, mark the highest grade completed or highest degree received.
On each completed MEDICATION INVENTORY, indicate the page number of each form by filling in the corresponding bubble. (For the first form, fill in the "1" bubble, for the second form, fill in the "2" bubble, etc.) The total number of forms will be recorded on the MEDICATIONS QUESTIONNAIRE.
1. Record the trade name (or generic name, if necessary). If the name of the medication is longer than the number of data entry boxes on the form, just fill out as much as possible.
2. Indicate the frequency the medication is taken.

Issue
Resolution Participant took a medication 1 week ago but stopped taking it  Record the medication Participant has not brought in all of his/her medications or has forgotten to bring all of them  Record the medications the Participant has with him/her and ask the participant to call you later with the name of the other medication(s).

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TOBACCO USE QUESTIONAIRRE
To determine the use of tobacco products in the study participants.
2. Immediate Referrals: Medical emergencies which require immediate notification of both the participant and his/her primary physician. Participants receiving immediate referrals should be considered as those who would go directly from the Clinical Site to their physician or hospital. Immediate notification of the participant should occur during the clinic visit. Immediate notification of the participant's physician should be accomplished by telephone, to be completed before the participant leaves the clinic. A follow-up letter documenting information discussed by phone should also be sent to the participant's physician for findings included in the initial report, or immediately upon receipt from the central agency for findings on the later reports.
3. Urgent Referrals: Urgent referrals are made for abnormalities detected which require medical attention but not on an emergency basis. Urgent notification of the participant should occur before the participant leaves the clinic (for findings included in the initial participant report), or immediately upon receipt from the central laboratory (for findings on later reports). Urgent notification of the participant's physician should be sent within the week.

General Instructions
Whenever one of the alerts listed above is identified for a participant, the actions defined under Immediate or Urgent Referrals, above, must be completed. Actions taken must be documented with a copy of the letter to the participant archived in the participant file.
2. Specific Instructions for Urgent or Immediate Referrals 2.1 If an "Urgent" or "Immediate" Referral result occurs, the Study Coordinator should notify the NU PI as soon as possible. Randomization is a process used in research studies to test the effectiveness of a new intervention (for example: a new medication or a new program) compared to a standard intervention. Participants will usually be evenly placed in different study groups. Participants do not have control over which group they may be assigned to. People who take part in studies requiring randomization are generally placed in a group based on chance, not choice. Some participants are placed in the "experimental" group, and the others are placed in the "control" group. The control group will receive standard treatment, a placebo, or other intervention based on the design of the study. In some studies the participants do not know to which group they have been assigned. This process, called randomization, allows researchers to compare results between the two groups. Randomization helps us increase our knowledge about which treatments or programs are better than others.

SAHELI STUDY PROCESS OF RANDOMIZATION
In this study we will be randomly assigning equal number of men and women into the control group and intervention group. Participants in both groups receive results of their blood work and referral to a primary care physician if they do not have one. The control group is the group that will receive printed health education materials and the intervention group will receive the group education classes.
To understand how this works, imagine that our total goal for enrollment in the study is 80 people. Each participant is randomly assigned to either the intervention group or the control group. To do this, we use a computer database program which is similar to "coin toss". Half of the people are assigned to the intervention group and half are assigned to the control group. We can then compare the results of the two groups to see which type of health education works better. We also try to figure out why it works better.
The program uses a Visual Basic for Applications (VBA) random number generator to produce customized sets of random alphanumeric characters.

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The randomization process in the study works in the following ways.
MAFS staff will call people who are interested to participate in the study Interested participants will be invited to the baseline screening visit Participants test results will be reviewed by Dr. Namratha Kandula Participants will return their accelerometers 7 days after baseline visit Check if participants have enough valid hour/days accelerometer data in order to participate Once we reach the target number of people (n=16) to initiate a cohort We use the database to randomly assign all 16 people into either the control or intervention group.
Randomization will be complete. No changes can be made In case a person is not interested in participating in the study after randomization Inform Dr. Namratha Kandula Only Dr. Namratha Kandula can authorize a deletion of record after any participant is assigned in the study. She will contact Andrew Cooper

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CHAPTER 6: ANTHROPOMETRY OVERVIEW
The purpose of the anthropometry procedures is to acquire general measures of body size, shape, and obesity.

MATERIALS AND EQUIPMENT
 Stadiometer (Accu-Hite Measure Device with level bubble) (height ruler with triangle level is used at some centers)  Balance Scale in lbs/kg OR Digital Scale  Gulick II 150 cm anthropometric tape  Full length mirror  ANTHROPOMETRY FORM (Appendix 7A)

General Instructions
For all measurements, participants should wear light clothing but no shoes (thin socks or "pillow slippers" are OK). Have participants completely empty their pockets and remove excessive amounts of jewelry that could affect the weight measurement. Provide lockers with locks for valuables.
Pregnant women should not be measured, regardless of gestational stage (check exclusion criteria for pregnancy). The Clinic Coordinator should ascertain pregnancy status, both for measurements and for subsequent coronary calcification measurement.
Take a single measurement at each body site and record on the anthropometry form using specific rounding rules for each procedure. Record any modifications in measurement techniques (e.g. height decreased from a hunched posture or weight that exceeds the capacity of the scale).
 Make sure to verify participant ID and acrostic  Verify or record date of the procedure at the top of the form  Enter Staff ID# of the staff member who is completing the measurement  Fill in visit bubble 1.

Standing Body Height
Equipment  Stadiometer (Accu-Hite Measure Device with level bubble) Preparation  Before measuring height, make sure the floor is level, the wall is at a 90 degree angle to the floor, the wall is straight, and the Stadiometer is mounted perpendicular to the floor.

Measurement
For accurate measurement of height, the participant must be standing in a vertical plane. To achieve this position, have the participant stand erect on the floor or horizontal platform, with back against the vertical Stadiometer, heels against the wall, and feet or knees together-whichever come together first. Have the participant look straight ahead, with head in the Frankfort horizontal plane (Figure 1).  Place the headboard over the crown of the head, with the headboard forming a right angle to the scale. The headboard should touch the scalp lightly.  Ask the participant to step out from under the headboard. Record the participant's height to the nearest 0.1 centimeter in Box 1a of the ANTHROPOMETRY FORM.
 If you are unable to measure the actual height of the participant because the headboard does not rest directly over the scalp, estimate height to the nearest 0.1 cm, record in Box 1a of the ANTHROPOMETRY FORM and answer "yes" to question 1b. "Was there a modification in protocol?"  Record the results, to the nearest tenth (0.1) of a cm, in question1a on the ANTHROPOMETRY FORM.  If any modification was made to obtain height, record "yes" to the question, "Was there a modification in protocol?" Completing the Data Form for Height Question 1.a. Measure the participant's height to the nearest tenth of a centimeter. Question 1.b. Any modification in measurement techniques should be specified by filling in the "yes" bubble, and will be taken into consideration for data analysis.

Body Weight
Equipment  Digital Scale or Balance Scale in lbs/kg Preparation The Frankfort Plane includes the lower margin of the bony orbit (the bony socket containing the eye) and the most forward point in the supratragal notch (the notch just above the anterior cartilaginous projections of the external ear)-also referred to as the upper margin of the external auditory meatus (the hole in the ear).  If the participant is too obese to stand securely on the scale's platform when looking straight ahead, he/she may stand sideways on the scale to take the weight measurement; facing to the side rather than the front will provide the participant a wider base and more stability.  If a participant has a prosthetic limb or breast prosthesis, measure weight with the prosthesis on.  If a participant is frail or unsteady, measure weight while participant is lightly steadied by you or an assistant.  If a participant is unable to stand on the scale for a weight measurement, do not attempt a weight measurement.  If any modification were made to obtain weight, record "yes" to the question 2b., "Was there a modification in protocol?" Completion of Data Form for Weight Question 2.a. The measurement should be recorded to the nearest one tenth of a pound on the ANTHROPOMETRY form Question 2.a.
Question 2.b. Any modification in measurement techniques should be specified by filling in the "yes" bubble, and will be taken into consideration for data analysis. Abdominal Girth  Use the Gulick II anthropometric tape  Move to the participant's right side to take the measurement; do not take this measurement from the front. Be sure to keep the tape horizontal while making the measurement; use the wall-mounted mirror to assure horizontal placement on all sides.  Take the measurement tape around the abdomen horizontally at midpoint between highest point of the iliac crest and lowest part of the costal margin in the mid-axillary line.  Mark the midpoint on both sides using a washable marker.  The participant may be asked to assist passing the tape around the abdomen by holding the end of the tape in position  When the tape is positioned in the horizontal plane at the correct height, the participant should be asked to keep their arms at their side and breathe in and out naturally, holding at the end of a normal exhalation.  Be sure to keep the tape horizontal while making the measurement; use the wall-mounted mirror to assure horizontal placement on all sides.  For participants with a slim abdomen, this horizontal plane will be at the level of the umbilicus---for those with a larger abdomen, the umbilicus will likely be lower.  Round abdominal girth measurement to the nearest 0.1cm and record in Box 3a, measurement 1.  Repeat the abdominal girth measurement and record in Box 3a, measurement 2.  If the circumference exceeds 150 cm, record "yes" for the question, "Was there a modification in protocol?"

Girth Measurements
Hip Girth  Take the hip girth measurement from the participant's right side; do not take this measurement from the front. Instruct the participant to stand with his/her feet together. Measure hip girth at the maximum circumference of the buttocks. Check to see that the tape is level in front and back.  Round hip girth measurement to the nearest 0.1cm and record in Box 3b, measurement 1.  Repeat the hip girth measurement and record in Box 3b, measurement 2.  If the circumference exceeds 150 cm, record "yes" for the question, "Was there a modification in protocol?" Completion of Data Form for Girth Question 3a: Enter first and second waist circumference measurements in centimeters.
Question 3b: Enter first and second hip circumference measurements in centimeters.
Question 3c: Any modification in measurement techniques should be specified by filling in the "yes" bubble, and will be taken into consideration for data analysis.

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Comments/Modifications to the Protocol
If you have comments or if there have been modifications to the protocol as described above, answer "yes" to question 4 on the ANTHROPOMETRY FORM and record comments in the space provided. If there are no comments or modifications, answer "no" to question 4.

QUALITY CONTROL
All SAHELI Staff performing anthropometry measurements must be trained and certified. Please see Chapter, Quality Control.

ROUNDING RULES
Round decimals to the nearest tenth (rounding position) using standard rounding rules:  If the number to the right of the rounding position is 5 or greater, increase the number in the rounding position by 1 (round up).

CHAPTER 7: BLOOD PRESSURE
OVERVIEW Blood pressure (BP) level is a major risk factor for coronary heart disease, congestive heart failure, and stroke. The purpose of a specific measurement protocol, or training and certifications of technicians, and of ongoing quality control is to minimize variability due to known exogenous factors and to reduce imprecision and biases in measurement. The Dinamap automated device will continue to be used for consistency and to reduce the potential for observer biases.
In addition, measurements of lean body mass and fat mass will be measured by bioelectrical impedance. The purpose is to provide a more accurate and direct measure of body fat than can be provided by calculation of the body mass index.

MATERIALS AND EQUIPMENT
 OMRON HEM -907XL sphygmomanometer  4 cuffs  Gulick II tape measure (for arm circumference).  Measuring tape  Alcohol wipes  Tissues  Water soluble markers  Watch or stop watch (to time five-minute rest and resting heart rate).  SEATED BLOOD PRESSURE form (Appendix 8A)

CLASSIFICATION OF THE PARTICIPANT'S BLOOD PRESSURE WITHIN THE JNC VI CATEGORIES AND CRITERIA FOR ALERTS AND REFERRALS
This classification and the criteria for alerts have not changed from Exam 1. However, they are important and are reiterated here.
The 1997 Report of the Joint National Committee on Detection, Evaluation, and Treatment of High Blood Pressure (JNC VI) defines categories of blood pressure and recommends follow-up according to the following criteria: CONFIDENTIAL-Do not distribute, developed by Northwestern University ** Diagnosis of hypertension must be based on two or more readings taken at each of two or more visits following an initial screening.
SBP= systolic blood pressure. DBP= diastolic blood pressure. 3. Alert levels requiring follow-up within two months time, and, therefore, we recommend physician notification for systolic or diastolic BP above these levels.
 BP >140/90 mm Hg 4. JNC VI states that blood pressure classifications and referral recommendations are based on the average of two or more readings on two or more occasions. In SAHELI we intend to use the average of the 2nd and 3rd blood pressure readings (see below) in order to reduce the impact of reactivity (higher first reading) on the estimate of the value of the underlying blood pressure. Thus, in deciding whether a participant meets criteria for an alert level, the average of the 2nd and 3rd readings should be used. This will require on-the-spot arithmetical manipulation of the systolic and diastolic values. A hand calculator may be useful. The data forms include fields for these averaged values and for any actions taken. Ask the participant to sit in the chair, adjust the chair if necessary and rest quietly for 5 minutes prior to blood pressure measurement. The health interviewer will explain the exam to the participant using a script: "Before taking your first blood pressure reading, there will be a 5 minute waiting period. When I inflate the cuff, it may feel tight and you will feel some pressure on your upper arm. While we are CONFIDENTIAL-Do not distribute, developed by Northwestern University measuring your blood pressure, we ask you not to talk and I will not talk either because talking and moving changes your blood pressure. Do you have any questions?" The right arm and back should be supported and the legs should be uncrossed with both feet flat on the floor. The right arm should be bared and unrestricted by clothing with the palm of the hand turned upward and the elbow slightly flexed.
The arm should be positioned so that the midpoint of the upper arm is at the level of the heart. Small or short participants may have to raise their body to the correct position by changing the chair position up or down. If necessary, especially with short participants, place the participant's feet on the footstool to stabilize their feet in a flat position. Very tall participants may need to place their arm on a book or pillow to bring their upper arm to the correct position.
For the purpose of standardization, both pulse and blood pressure are measured in the right arm unless one of the following conditions applies: 1. The participant indicates that the blood pressure procedure should not use the right arm (for example, because of a history of mastectomy or fistula).
In the above condition, the blood pressure measurement must be taken in the left arm. Use of the right or left arm must be recorded on the blood pressure (BP) recording form. BP measurements are not done on any arm that has rashes, small gauze/adhesive dressings, casts, is puffy, has tubes, open sores, hematomas, wounds, arteriovenous (AV) shunt, or any other intravenous access device. Also, women who have had a unilateral radical mastectomy do not have their blood pressure measured in the arm on the same side as the mastectomy was performed. In all cases, if there is a problem with both arms, the blood pressure is not measured.

Locating the Pulse Points
Locate the brachial artery by palpation and mark the skin with a small dot, using a black pen. (The brachial artery is usually found just medial and superior to the cubital fossa posterior to the biceps muscle and slightly towards the body). For brachial artery palpitation, fingertips or thumb may be used.

Cuff Size Selection and Application
It is important to select the appropriate size cuff that properly fits the participant's arm. The length and width of the bladder inside the cuff should encircle at least 80 percent and 40 percent of an arm respectively. The index lines on the cuff are not used in this study. Using a centimeter tape, determine the midpoint of the upper arm by measuring the length of the arm between the acromion and olecranon process (between the shoulder and elbow).

Measurement of Arm Circumference
Have a participant remove his/her upper garment, or clear the upper arm area so that an unencumbered measurement may be made. If the upper garment is removed, a gown must be provided to the patient. i.
Have the participant stand, with the right arm hanging and bending the elbow so that the forearm is horizontal (parallel) to the floor. ii.
Measure arm length from the acromion (bony protuberance at the shoulder) to the olecranon (tip of the elbow), using the Gulick II anthropometric tape.

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iii. Mark the midpoint on the dorsal surface of the arm. iv.
Have the participant relax the arm along side of the body. v.
Draw the tape snugly around the arm at the midpoint mark. NOTE: Keep the tape horizontal. Tape should not indent the skin. vi.
Pull the gulick II tape measure until one red ball is visible. This is the measurement of arm circumference that should be used.

Choosing the Correct Cuff Size
Identify the measured arm circumference under the column I in Table 1 below. Use the cuff size from column 2 associated with the arm circumference in column 1. (Example: If the arm circumference at midpoint is 36cm, use the large adult cuff marked CL19.)

Wrapping the Blood Pressure Cuff around the Arm
Position the rubber bladder with the "art" label on the bottom of the cuff just above the pen mark over the brachial artery pulse determined earlier at least one inch above the crease of the elbow. The cuff tubing should be at the outer (lateral) edge of the arm if the cuff is placed correctly.
For short or fat conical arms, if the cuff that matches the arm circumference is too wide to fit on the upper arm with space above the brachial artery pulse point at the cubital fossa then choose the next smaller cuff size and enter the cuff size chosen on the BP recording form.
Place the "artery" marker on the inner part of the cuff directly over the brachial artery. The cuff should be wrapped in a circular manner. Do not wrap the cuff in any spiral direction. Check the fit of the cuff to ensure that it is secure but not tight.

Procedure for the OMRON HEM-907XL
This protocol is written for use with the OMRON HEM-907XL automated blood pressure monitor. Special attention must be placed on assessment and maintenance of the instrument's accuracy as per the manual that accompanies the instrument. The design and operation of the OMRON HEM-907XL are based upon the combined principles of compression of the brachial artery under an elastic, inflatable cuff and estimation of the systolic and diastolic blood pressure levels by detection of oscillometric waves.

Setting up the OMRON
At a start of each session: Check that the monitor is attached to the AC adapter to the DC jack and plugged in and AC sign is visible in the lower window.

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When the power is OFF, push the ON/OFF (power) button for more than three seconds while holding the START button simultaneously: F1 is displayed in the first window and three inflation (3)   For all cuff sizes, connect the air tube to the main unit by attaching the air plug to the base of the air connector. Connect the cuff to the air tube attached to the OMRON unit. Wrap and secure the appropriate cuff to the participant's upper right arm as described above.

Push the START button to Start the Measurements
The cuff will inflate automatically and deflation will begin after the OMRON detects no osillometric waves. The dial will show sequentially in the bottom panel of the LCD screen. Three measures will be taken with 30 seconds between each.
After each inflation and deflation the systolic blood pressure, diastolic blood pressure and pulse rate will be displayed in the top, middle and bottom sections of the LCD screen.
After the first and second measurements are displayed there will be a preset 30 second interval before the beginning of the next measurement. During this time have the participant raise their cuffed arm all the way above their head for the count of 5 seconds and then return to the original resting position with the arm supported with the cubital fossa at heart level. Do not clench the fist. This action is to avoid venous congestion in the arm that may not have dissipated after inflation of the cuffwhich in turn could increase the pressure recorded on subsequent measurements. After all the inflations are finished, each time the DEFLATION button is pushed the measurement results  for each reading will be displayed along with a small display in the bottom window indicating the order of  display: Avg, 1, 2, 3 inflations. Record all the systolic and diastolic blood pressure levels for the first, second, and third measurements separately on the Sitting Blood Pressure (SBP) form. Record the average systolic and diastolic blood pressure measurements and the average pulse rate, respectively.

Recording the OMRON Results
Push the ON/OFF button. This terminates the exam and you are ready for the next participant.
The blood pressure results will be reviewed with the participant at the time of their discharge from the study visit. If the average blood pressure is equal to or greater than 200 mmHg systolic or equal to or greater than 120 mmHg diastolic the technician records the value in the data entry system, closes out the data entry screen per protocol and immediately page Dr. Namratha Kandula (pager 312-695-8630) or a covering physician. The health interviewer will arrange appropriate follow-up after speaking with Dr. Kandula or the covering physician, including accompanying the participant to the nearest emergency room for medical evaluation of the participant's blood pressure. The participant's blood pressure values are not discussed at the blood pressure station nor during the measurement process. If pressed, the technician can add that the research protocol requires that results not be discussed during the examination. The OMRON display and the computer monitor should be turned away from the participant so that the blood pressure values being recorded are not easily visible.

Equipment Maintenance
The following sections specifically state the steps that technicians follow to check equipment and maintain equipment used for the technician examination.

OMRON HEM-907XL
Weekly -Wipe the monitor with a soft, damp cloth diluted with disinfectant alcohol, or diluted detergent. Complete cleaning by wiping the monitor with a soft, dry cloth.
Blood Pressure Cuffs: Check the inflation cuff for cleanliness, and wipe between each use with disinfectant wipes.

Calibration
Monthly calibration is required for the OMRON machine. Makes sure that the arm is entirely exposed, asking the participant to change into a hospital gown if needed.

2.
Asks patient to stand with the arm bent 90 degrees at elbow.

3.
Uses Gulick tape measure to measure length of upper arm.

4.
Measures length between the acromion (bony protuberance at top of shoulder located somewhat anteriorally) and the olecranon (tip of elbow).

5.
Marks midpoint of that length with pen. 6.
Asks patient to let the arm hang relaxed at side. 7.
Uses Gulick tape measure to measure circumference of upper arm at the midpoint that was marked with the pen. 8.
Pulls tape to tautness that causes exactly one red ball to show in the window indicator. 9.
Records arms circumference on data page. 10.
Notes which size blood pressure cuff to use and marks this on data page. 11.
Asks patient to sit in chair and adjusts height of chair if needed. Patient should be positioned so that the right arm and back are supported. The feet should not be crossed and should rest with the bottom of both feet on the floor. For shorter individuals, a telephone book to support their feet if needed.

12.
Locates the brachial pulse in the antecubital fossa by palpation. Marks the location of the artery with a pen. 13.
Puts on the appropriate blood pressure cuff. Ensures that the "art" label on the blood pressure cuff is directly above the pen mark. Ensures that there is one inch between the bottom of the blood pressure cuff and the crease of the elbow. 14.
Checks for proper positioning of arm. The arm should be positioned so that the antecubital fossa is at the level of the heart. Small or short participants may have to raise their body to the correct position by changing the chair position up or down. Very tall participants may need to rest their arm on a book or pillow to achieve proper positioning.

15.
Explain that patient needs to relax and be quiet for a 5-minute rest period. Says the following verbatim, "Before taking your first blood pressure reading, there will be a 5 minute waiting period. When I inflate the cuff, it may feel tight and you will feel some pressure on your upper arm. While we are measuring your blood pressure, we ask you not to talk and I will not talk either because talking and moving changes your blood pressure. Do you have any questions?" 16.
Leaves for 5 minutes.

17.
Returns and sets up Omron blood pressure machine, making sure it is plugged in. Press "start" to show the value for F2. F2 is the waiting time before starting inflations and should be set to zero. If needed, the deflation button can be used to change the setting for F2. 21.
Press "start" to show the value for F3. F3 is the time interval between each blood pressure reading and should be set to 30 seconds. If needed, the 'deflation" button can be used to change the value for F3 to 30.
Turn the Omron machine back on by pressing "start". 24.
Waits for 2 minutes between the first and second blood pressure readings 25.
Waits for 2 minutes between the second and third blood pressure readings 26.
When all three readings are finished, record all three systolic/diastolic blood pressure readings and the average of last 2 systolic/diastolic blood pressure and pulse. 27.
If the average systolic blood pressure reading is equal to or greater than 170 mm Hg OR if the average diastolic blood pressure reading is equal to or greater than 110 mm Hg, the coordinator stops immediately and pages Dr. Kandula.

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CHAPTER 8: ACCELEROMETERS OVERVIEW
The accelerometer (motion sensor) is used to measure the participant's level of activity. A team member will instruct the participant to wear the motion sensor during all waking hours (at least 10 hours/day) for the next seven (7) days. To increase the likelihood that participants wear the motion sensors properly, a team member will explain the purpose of the motion sensor, fit the participant with a belt and sensor and give instructions for wearing the sensor. At the baseline visit, the team member will also provide instructions for returning the accelerometer.

ACCELEROMETER SETUP
There are many types of motion sensors. In this study we will be using the GT3X+ motion sensor developed by ActiGraph. Data collected by ActiGraph motion sensors are accessible only through the ActiGraph software. The initial set up of the motion sensor has to be done before the participant comes in for each visit (baseline, 3-and 6 months).

PLACEMENT OF ACTIGRAPH
The Actigraph motion sensor comes with a waistband that will be worn around the hip. It should be worn snuggly around the hip (as close as possible to the right hip bone). (See Appendix 9A for details). It is important that the accelerometer is fastened tightly or measurements will be inaccurate. The motion sensor can be worn either over or under clothing.

PREPPING THE PARTICIPANT
The participant will be responsible for wearing and removing the motion sensor. Show the participant how to wear the motion sensor (directions in Appendix 8A). Provide the necessary instructions and contact information to the participant. Review the instructions with the participant and ask them to wear the motion sensor for at least 7 days. Give the participant the reminder card (Appendix 8C) to place in an area where they will see it every morning and remember to wear the motion sensor. Specifically point out that they take off the sensor before going to sleep and put it on again in the morning and to take it off before a shower or swim. Schedule a visit for the participant to come in and return the motion sensor.

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Each time you give the participant the ActiGraph, complete the ActiGraph Distribution form (Appendix 8D). Record the person's full name on the form, whether or not the participant received an ActiGraph and the serial number of the ActiGraph.

INTERIM TELEPHONE CONTACT
Participants will be called three times during the 7 days they are wearing the motion sensor (see Appendix 8B for phone call script). First call will be next day morning to make sure the participant understands how to wear the motion sensor. Second call will be on the 3 rd or 4 th day of the week to make sure everything is going well and answer any questions the participant may have. Third call will be one day before the participant is scheduled to return the motion sensor to remind them of their appointment with the project staff.
An effort will be made to schedule these reminder calls with the 24-hour food recall (see Chapter 10 for details on 24-hour food recall telephone calls).

COMPLETE THE ACTIGRAPH RETURN AND READING FORM
At the next appointment, 7 to 8 days after the first appointment, the participants will return the motion sensor. Please complete the Return and Reading Form (Appendix 8E) when the participant returns the sensor.

Saheli
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APPENDIX 8A ACCELEROMETER SCRIPT
The following pages contain the script to lead the team member and participant through the orientation meeting. Topics covered include: 1. Instructions for when and how to wear the motion sensor 2. Fitting the sensor 3. Review of instructions and returning the sensor To ensure consistency of instructions that are given to each participant, please follow the scriptspoken words are in italics and additional instructions to the team member are in brackets.

Explain How and When to Wear the Sensor
"As a part of this study, we are asking you to wear a motion sensor every day for the next seven days in a row. Today I will show you how to wear the motion sensor and go over instructions for when to wear it." "Let's go over the instructions for wearing the monitor in detail now." "You should wear the motion sensor during all hours that you are awake over the next seven days. Put the sensor on first thing in the morning when you wake up, and take it off at night for bed. Put the sensor somewhere safe, where you will see it in the morning and put it on again right away." "There is no on/off button or anything you need to adjust during the next seven days." "Wear the sensor during all the hours that you are awakeat least 10 hours per day. The sensor needs to stay dry, so take it off to shower, take a bath or swim. Make sure to put the sensor back on when you are done." "Be careful when changing clothes, going to the bathroom or other types of activities where you could drop the sensor or it could get hit hard. The sensor will not break if it is bumped, but please be careful when using the bathroom that the sensor does not fall into the toilet."

"It is very important that you go about your normal, everyday activities this week, and you do not make changes to your routines. You should do your daily activities just as you would without the sensor."
"Do you have any questions about when to wear the sensor?"  The purpose of a 24-hour dietary recall is to gain information regarding the participant's diet. Study staff will be trained to conduct 24-hour food recalls in order to examine the initial efficacy of the South Asian Heart Lifestyle Intervention (SAHELI) to change saturated fat intake and fruit and vegetable consumption among South Asians. For the 24-hour dietary recall, the participant is asked to remember and report all the foods and beverages consumed in the preceding 24 hours (from midnight to midnight). The recalls will be conducted by interview, both in-person and by telephone, using a semi-scripted form. The information collected during the 24-hour recall interview will be entered into the Nutrition Data System for Research (NDSR) 2011, a computer based software application created by the University of Minnesota Nutrition Coordinating Center (NCC), for nutritional analysis and assessment.

24-HOUR DIETARY RECALL COLLECTION METHOD Schedule
Three 24-hour dietary recall interviews (2 weekdays and 1 weekend day) will be collected from each study participant in both the control and intervention group at baseline, 3-month and 6-month. The first 24-hour food recall will be conducted in-person, at the baseline visit. Staff will then contact study participants within one week of the visit to conduct two 24-hour food recalls over the telephone. The 24-hour food recalls conducted on a weekend day will be made over the telephone. The dates and times of these recalls will be unannounced (unscheduled) so that participants do not change their normal eating pattern. However, during the visits, the participants will be asked to indicate the preferred days of the week and times of day to be called and the telephone number(s) at which they may be reached. Email addresses will also be collected and used when participants are difficult to reach by phone.

3-month 6-month Day of visit
One in-person 24-hour dietary recall Within one week of visit Two over-the-phone 24-hour dietary recalls (one on weekend day) A calendar should be available for each dietary interviewer and participant. This can be used at the beginning of the in-person dietary interview to assist the participant in recalling yesterday's dietary intake and in looking at availability for the telephone dietary recalls. The participant's availability for the telephone dietary recalls will be recorded on a calendar and be given to the participant.

Multiple-Pass Approach Description
The multiple-pass method enhances and improves the 24-hour dietary recall by providing respondents with multiple cues and opportunities to help them remember and describe foods they consumed. It minimizes underreporting of dietary intake and facilitates the collection of recalls in a standardized fashion. For this study, we will be using the multiple-pass approach for data collection as described in the NDSR 2011 manual which uses four distinct passes. A total of four passes which means the first pass involves obtaining from the participant a listing of all foods and beverages consumed in the previous 24 hours. This listing is reviewed with the participant for completeness and correctness in the second pass. During the third pass, the interviewer then collects detailed information about each reported food and beverage, including the amount consumed and method of preparation. Finally, in the fourth pass, the detailed information is reviewed for completeness and correctness.

Amount Estimation Tools for In-person Interviews
Accurate quantification of foods and beverages is essential for obtaining useful dietary data. Some participants are more adept than others in accurately estimating amounts of foods and beverages but all should have access to the same tools to aid in this process. For in-person interviews, each interview station should have a complete set of amount estimation tools. This set will include an assortment of household cups, glasses, spoons, bowls, a ruler, replicas of select foods (Nasco models), and a copy of the Food Amounts Booklet (FAB) available from NCC. To promote participant understanding of how to use the FAB, the dietary interviewers will briefly describe the pages before proceeding to collect the 24-hour recall. Also, the participant will be given a copy of the FAB to take home for use during the telephone recalls. The interviewer copy includes specific amount measure labels on each picture as well as a one page conversion guide. To retain scale, the FAB must be printed on 8.5x11 inch paper, 1 page per sheet of paper. Also, make sure the page scaling is set to 'none' and the 'Auto-Rotate and Center' button is on. To make sure the booklet was printed to scale, measure the circles on page 2 of the booklet to confirm they match the measurements specified on that page of the interviewer copy of the booklet. See Appendix 10B for the Food Amounts Booklet.

Amount Estimation Tools for Telephone Interviews
The Food Amount Booklet is given to participants at the in-person interview to be used during the telephone interviews. As mentioned earlier, during the in-person interview, orientation to the FAB will occur in conjunction with other amount estimation tools to help the participant understand how to recall and estimate the quantities of foods consumed.
Household measuring cups and spoons:

Introducing Participant to the Dietary Recall Interview
When the participant arrives, the dietary interviewer welcomes the participants to the dietary recall portion of the visit. He/she introduces himself/herself in a friendly but professional manner and gives basic information about the dietary interview to the participant and responds to any questions the participant may have. The dietary interviewer will explain that he/she will be asking the participant what they ate and drank yesterday and will be recording this information on the form. The dietary interviewer should always give neutral responses to whatever the participant tells them and should help the participant feel comfortable to encourage honesty. It can be hard to remember everything eaten in the last 24 hours so allow for questions and comments.
When conducting a telephone interview ask the participant if they have the Food Amounts Booklet (FAB) with them or can take a minute to go find it for use during the interview. If the participant can't find the booklet, write down the participant's mailing address and let him/her know that a new booklet will be mailed to them. Thank them for their time and let them know you'll call them back after the booklet has been mailed. If the participant has been difficult to reach by phone (e.g. repeated attempts have been made to reach the participant for the telephone recalls), proceed with the interview without the booklet. Please note that interview was conducted without FAB.

The First Pass
The first pass is used to collect an outline of the previous day's intake. It is designed to get participants to begin thinking about what and when they ate. The dietary interviewer asks when was the first time the participant had something to eat or drink and what they had at that time. The interviewer prompts the participant by asking them if they had anything else at that time. The interviewer then asks the same questions for the next time(s) they had something to eat or drink.

The Second Pass
In the second pass, the interviewer reviews the list by reading each meal time and foods they had at each meal time. The dietary interviewer prompts the participant by asking them again if they had anything else at those times, if they had a beverage with any meals, if they had any snacks between meals or if they sampled food as they prepared for the meal.

The Third Pass
During the third pass, the interviewer informs the participant that now they will look at the foods on the list with more detail. The interviewer starts by asking where they had each meal for each different meal time. Based on the participant's response, the interviewer can select from the following locations: home, work, friend's home, school, day care, restaurant/cafeteria/fast food, deli/take-out/store, community meal program, party/reception/sporting event, or other. The meal location helps to determine which food variables to enter when entering the 24-hour dietary recall information into NDSR. For example, many foods in NDSR differentiate between home prepared and restaurant prepared foods. Collecting information on the source of the meal aids in the food description process.

Food Description
For each food listed, the interviewer will determine which questions to ask. For individual food items such as milk, juice, cheese, meat snack foods like potato chips, the interviewer will ask what type of food it was to elicit responses such as name of specific food like chocolate milk or 100% orange juice and to see if foods had varying nutrient content for example, skim vs. 2% milk, 85% lean ground turkey, low fat or fat free yogurt, whole egg or egg whites, low sodium canned goods, sugar free Jello, etc. It is also important to ask the form purchased (e.g. fresh, frozen, canned, dry, etc.) especially for foods like fruits, vegetables and beans and to ask for brand name if any. Make sure to ask if anything was added to the food during prep or at the table. These are things like solid fats, oils, dressings, cream, sugar, or condiments. For a mixed dish made or prepared by the participant, ask the participant for recipe details such as what ingredients were used, amounts of ingredients used and method of preparation (e.g. boiled, baked, fried, breaded, etc.) Also, determine the difference between the servings made and the amount eaten by the participant. The amount eaten by the participant will be verified in the next step when determining quantity and unit size, however, if the participant is able to give recipe details, it is important to note how many serving sizes that the recipe made so the information can be appropriately entered in NDSR later. If a mixed dish such as a sandwich or taco is reported to be from a national fast food restaurant chain, record the name of the restaurant. It is not necessary to ask the participant for each ingredient in the food, though. Any modifications made to national fast food restaurant meals, such as not eating the bun for a McDonald's hamburger or ordering a Subway sandwich with only vegetables, should be recorded.

Food Amount
For each food or mixed dish, record the amount, both quantity and unit size. For example, 1 large egg ('1' is the quantity and 'large' is the unit size). Unit size includes food specific units, geometric food shapes, weight, and volume.
If it is the first interview, the dietary interviewer should introduce the study amount estimation tools. The dietary interviewer should explain to the participant that the FAB includes examples of eating and serving spoons, glasses, mugs and bowls which can be different sizes compared to measuring spoons and cups. Showing the Nasco food models helps the participant visualize the amount of a specific food. If a participant is describing the amount of food, it is also helpful for him/her to see the 'Mounds' pictures on pages 14 and 15 of the FAB. Nasco meat food models will be available but for further assistance in determining size and portion of meat, the dietary interviewer can refer to the 'Meats' pictures on page 16 through 18 of the FAB. Emphasize that these tools are not always needed for estimating amounts and give

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examples of amounts that can be expressed using food-specific unit such as a "large" apple or a "thin slice" of tomato. The dietary interviewer should remind the participant that he/she needs to know the amount actually eaten or drunk, not the total amount on the plate or in the glass, or the amount that was prepared for the entire family. When an amount is given by the participant, the dietary interviewer asks if he/she ate all or only a part of that amount.
Interviewers should not specify to the participant a particular method to use to estimate the amount of food or beverage. First, he/she asks a completely open-ended question such as "how much juice did you drink?" This type of question encourages the participant to express the amount in his/her own words. If the participant appears to be having difficulty answering the question, the dietary interviewer may then suggest that he/she try to visualize the juice container and compare the amount with one of the amount estimation tools. If the participant continues having difficulty expressing the amount, the dietary interviewer might mention one or more of the options listed as examples depending on the food.
Food specific units, e.g., slices, each, small, single serving bag, piece, are available for many foods in NDSR and can be recorded as such. Food specific units are most frequently available for packaged items such as one piece of hard candy or an ice cream bar. In general, it is better to use the "small", "medium", or "large" food specific unit to describe pieces of chicken and fruit. These foods tend to be overestimated when dimensions are used because the visual image includes refuse (e.g. bone, core, peel). Foods that may seem "standard" can come in several sizes (e.g. nugget, regular, small, extra-large). Therefore, it is preferable to have the participant describe the portion consumed using the amount estimation tools (i.e. measuring cups and spoons, Nasco food models, the FAB). For example, if the participant reports having a small doughnut, record that the participant reported small and use the Food Amounts Booklet to get a rough idea of the size and record the dimensions. The person entering the 24 hour dietary recall data will then determine if that dimension is associated with the food specific unit. See photo below for an example of the food specific units of a doughnut and how they are further described using dimensions.

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Shapes (e.g. circle, rectangle, wedge, cube) allow the participant to use two or three dimensions to describe the amount of food eaten. Food shapes in NDSR are measured using inches to describe length, width, height or diameter depending on the food. In the event that a participant reports the food shape in centimeters, the dietary interviewer refers him/her to the ruler that has inches and centimeters. Notes should be taken for any unusual dimensions, making clear that the dietary interviewer has visualized the food and is aware of any unusual dimensions and has probed sufficiently to be sure the participant has given the best description for the amount consumed. Shapes are not permitted for describing liquid and in many situations; the food specific unit is a better way to quantify the food item because few foods have true geometric shapes.
Weight measurements (e.g., ounce, pound, grams) should only be used if the exact weight is available from a package label or if the participant reports an amount using an amount estimation tool that represents weight for that specific food. Pictures or meat replicas can be used to assist participants in describing their portion sizes of cooked meat including roast, steak, pork chop, and ham. (Note: chicken parts/pieces in the Food Amounts Booklet do not have weights associated with them and are considered food-specific units.) The meat replica pictures in the Food Amounts Booklet should not be used to represent cold cuts, sausage, meat loaf, or fish because the same volume for these items (meat replicas) will have different weight. NDSR will require if the meat portions include either bones or fat, and if the fat was eaten. Consequently, the dietary interviewer should clarify with the participant if the amount of meat or fish envisioned by looking at the picture or the replica includes bone or other refuse.
Volume measures (e.g., cup, fluid ounce, tablespoon, teaspoon, pint) are used to describe amounts for all liquid items, beverages, and non-liquid foods served or quantified in bowls, cups, or glasses. Examples in the Food Amounts Booklet include pictures of measuring cups and spoons, bowls, and glasses. If volume measurements are being used to describe non-liquid foods, include the quantity and form in which the food was eaten (e.g., sliced, diced, solid). The form determines the amount that can be placed in a particular container and factors in the density of the food item. For most beverages, NDSR will ask if the amount included ice, consequently the dietary interviewer should clarify if the amount the participant CONFIDENTIAL-Do not distribute, developed by Northwestern University reports includes ice. When using measuring cups or the bowls or beverage containers with the markings, dietary interviewers do not assume that the container was full. Always ask "To what line?" before entering the amount information. If the participant reports eating more than one of an item that could be different sizes, the dietary interviewer needs to remember to ask if they were the same size.
The amount the participant actually consumed is what should be entered, not what was served or cooked for the entire family. Double check to ensure that the amount reported is what was consumed. Asking "Were you able to finish that?" or "Did you eat all of it?" help to identify the unconsumed portions. The dietary interviewer must be able to visualize the amount reported and confirm as needed any questionable amounts using the amount estimation tools or by making reference to other familiar items or recognizable standards. For example, 1/16 of a hamburger should have a note saying, "ate only one bite" or 8 cups of popcorn should have a note saying, "ate entire box."

Things to Consider When Attaining Food Description and Amount
If something sounds unusual, the dietary interviewer should question it and not blindly accept the initial response. Redirecting questions and presenting appropriate alternatives from the amount estimation tools permit the participant to restate his/her initial response and allow the interviewer to verify, confirm, or correct an unusual portion. Confirmation of any unusual intake or portions should be documented by stating which amount estimation tool or picture in the Food Amounts Booklet was used.
As a general rule, the dietary interviewer should accept the participant's level of detail or opinion about the foods and beverages eaten. Participants would not be expected to be able to provide the answers to specific questions, especially regarding preparation methods or other details as part of a restaurant meal.
When it becomes clear that the participant is unable to provide the level of detail asked of them, please write "unknown". NDSR unknown will then be selected when entering dietary recall information. For example, if the participant had a meat empanada from a restaurant, the percent of fat will be unknown. It is essential to probe participants to determine the accurate nutrient content of foods however, asking too many questions that cannot possibly be answered may lead the participant to respond inappropriately just to provide an answer to the question.

The Fourth Pass
The fourth pass involves a final review of the record. The dietary interviewer should go through each food with the reported amount at each meal time and ask if it is correct. At the end of each meal time, the dietary interviewer should ask if the participant had anything else at that time. The dietary interviewer should try to get a mental picture of the day, looking especially for time gaps of more than four hours between eating. Notes should be made to indicate skipped meals or to explain large time gaps. Notes should also be used to record the absence of foods, beverages or typical condiments served with food.
When the dietary interviewer notices a large time gap, he/she should ask: "Did you have anything to eat or drink after the last meal? Anything before (insert time) and (before bed)?" If the participant hesitates and can't remember eating anything for a long period of time, the dietary interviewer may say: "Can you think of what you were doing (after work, at dinner/supper time, etc.)? Sometimes if we think about what we were doing, where we were or whom we were with, it helps to remember what we ate." When the 24-hour dietary recall interview is completed, ask the participant, "in terms of the amount of food you ate, would you say this was close to the amount that you usually eat, a lot more than you usually eat, or a lot less than you usually eat?" This question refers to the overall amount of food for the day, not the type of food. The dietary interviewer records the participant's response. If the amount is identified as

APPENDIX 9B: FOOD AMOUNTS BOOKLET
Note: The following pages are just for reference and are not to be printed and used during the 24-hour dietary recall as they are not in scale. Print the saved FAB interviewer and FAB participant PDF downloaded from the NDSR website and follow the instructions for printing in scale.

SN QUESTIONNAIRE Introduction
Provide a brief overview and purpose of the questionnaire to each study participant before beginning the questionnaire. A sample "overview" script is provided at the beginning of the questionnaire.

First name generator
A name generator is used to construct the participant's social network. Begin the questionnaire by asking the first name generator. Use the sample "introduction" script provided on the questionnaire to introduce the first name generator.
It may be hard for some people to understand whom the interviewer is asking about. Some people may respond by saying, "Are these people in my family?" In such cases, the interviewer needs to provide more clarification. Clarify by using the following prompt: ("This could be a person you tend to talk to about things that are important to you. This can include your family, friends, relatives, neighbors, co-workers or anyone else you discuss important matters about yourself").
Record the initials of the people the participant lists on "Roster A." Once the participant stops listing people, state the second prompt: "Is there anyone else that you discuss important matters about yourself?"). If the participant lists more people, continue to record their initials on Roster A. The general rule is to continue to prompt until the participant signals that those are all the people with whom they discuss important matters. A common response if the participant cannot think of anyone else might be, "No, those are all the people I discuss important things with." If a participant lists two or more people with the same initials (ex. KS, KS, KS) use numbers after the initial to identify between them (ex. KS1, KS2, KS3).

Network questions
Record initials of all the people from "Roster A" on row A1 (see below for example).
Use the following prompt to let the participant know that you will now ask some questions about the people they have just listed: ("Now I will ask you some questions about these people that you have just listed"). Begin asking question A2 through question A21.
Many of the questions have responses that the interviewer can mark directly on the questionnaire (ex. Question A3). For other questions, the interviewer will need to use the appropriate "handcard" to enter the correct code for each response (ex. Question A2). If a question requires the use of a handcard, it will be listed with the question. Finally, there are some questions -for example "How old is [name]"which requires the interviewer to enter the exact number given by the participant.

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For questions A2 through question A29, it is important to ask each question for all of the people listed before moving on to the next question. For example, question A2 asks about what the participant's relationship is with each of the people listed. The interviewer would ask how each network member (person 1, person 2, person 3, etc.) is related to the participant and would then enter the appropriate code using "Handcard A" (see above for example). Once question A2 has been asked for all the people listed, the interviewer will then move to question A3. Again, ask the question for all of the people listed before moving on to the next question. Question A30 asks about the frequency of how often the participant talks to each person they list in "Roster A" and how often the people they list talk amongst themselves. Record the initials of the participant in the cells labeled "ego" and the initials of the people from "Roster A" in their corresponding cells. Remember to lists the initials on both row 1 and column 1 of the table. (See below for example) Begin by asking how often the participant (ego) talks to each person (person 1, person 2, person 3 etc.) going down column two (see above for example). Once column two has been complete move to column three and ask how often person 1 talks to each of the other people listed (ex. how often does person 1 talks to person 2, person 3, person 4 etc.). Continue this pattern for all the people listed. Remember to enter the appropriate codes from "Handcard E" into the appropriate cells. Do not enter any codes into the gray cells.

Second name generator
The second name generator is more specific and asks about any other people the participant talks to specifically about their health that they have not already mentioned in the first name generator. Use question 1 on "Roster B" ("Do you talk to anyone else NOT on the list that you talk to about your health?") to prompt the participant to think about anyone else they have not mentioned with whom they talk to about their health.
Record the initials of the people listed in Roster B. Prompt ("Is there anyone else?"). Use "Handcard A" to ask about the relationship of the participant to each person listed in "Roster B." The interviewer does not need to ask question A2 through question A30 for people listed in "Roster B." CLOSING Review the questionnaire to make sure all the questions have been answered. If complete, thank the participant for their time.

CHAPTER 11: LINKAGE TO PRIMARY CARE OVERVEIW
Involving and communicating with research participants primary care providers is an important part of the study. Study participants will be encouraged to discuss their tests results with their primary care provider and any follow-up or clarifying information about tests results will be provided by Dr. Namratha Kandula, if requested.

Participants who already have a primary care provider (PCP)
Study participants, in the control and intervention arms, will be asked to provide the name and contact information of their PCP. All test results, anthropometrics and blood work, will be sent to the participant's PCP with a brief letter letting the PCP know that the patient is in the study and alerting the PCP to any abnormal results.
Participants will be sent a letter with their test results and will be instructed to follow-up with their PCP.
The research coordinator will contact any participant with urgent values and help participants arrange follow up with the PCP within 1 week. All other participants will be instructed to follow-up with their PCP within 8-12 weeks. The research coordinator who conducted the baseline visit will ask the participant if s/he wants assistance making the appointment. If the participants requests assistance, the research coordinator will call the PCP office and schedule the appointment within 6-12 weeks and notify participant.

Participants who do not have a primary care provider
If the study participant does not have a primary care doctor, the study team will provide referrals to local primary care providers and telephone assistance in making an appointment. The research assistant will assign the participant to a PCP in a free-clinic in the community. The research coordinator will call free clinics and make an appointment during the week, within the next 6-12 weeks. They will then relay the time and date of the appointment to the study participant through a phone conversation, a mailed letter, or a phone message. The participant can also elect to make their own appointment.
The main goal is that all the participants see their provider at least once during the 6-month study followup. Participants do not have control over which group they may be assigned to. People who take part in studies requiring randomization are generally placed in a group based on chance, not choice. Some participants are placed in the "intervention" group, and the others are placed in the "control" group.
Below is an overview of what each group (control and intervention) will receive as part of this study.

SAHELI CONTROL GROUP
The SAHELI study is a Randomized Control Trial (RCT). The SAHELI study has two study groups: the Print Health Education group (control group) and the Lifestyle Intervention group (intervention group). Participants will be randomly assigned to one of these two groups (See Chapter 15 Randomization for details). The randomization will occur after the baseline visit has been completed and after the accelerometer has been returned.
Participants in the Print Health Education group will receive blood tests and will be asked to follow-up with their primary care provider (PCP). In case they do not have a primary care provider, they will be referred to a provider. Participants will also receive monthly health education material about heart disease prevention as part of the study.

Assessment visits (Baseline, 3 months, and 6 months)
During each assessment visit, all control group participants will complete the following: Participants will receive their lab results when they return the accelerometer 7 days after each visit.

PRIMARY CARE REFERRAL
At the time when participant pick up their lab results, participants in the control group who do not have a primary care provider will receive primary care information (See Appendix 12A). The study staff will provide basic information about participants' lab results; however, it will be up to the participant to discuss their lab results in detail with their health care provider and seek appropriate care if needed. We will follow-up with these participants and ensure that adequate help, if needed, is provided in order to schedule an appointment to see a PCP. Help may be needed in areas like calling a providers office to set up an appointment for finding a clinic that provides free or care on a sliding fee scale.

PRINT HEALTH EDUCATION
Participant in the control group will receive health education material about heart disease prevention in the mail every month. The mailings will be sent via mail during the first week of the month. This information will be made available in both English and Hindi. Participant will be asked whether they prefer to receive information in Hindi or English.
Print materials will be housed in the folder on the Northwestern University server at:

P:\South Asian\R21\Control group materials
The health education material topics are the following: 1 st month -Looking after your heart 2 nd month -Eating healthy foods 3 rd month -Staying active 4 th month -Salt and fat 5 th month -Coronary heart disease 6 th month -Stress Optional -Smoke cessation Print materials will be reviewed every 6 months by study staff to ensure that the information is accurate and up to date. Decision to change or update the materials will be made in conjunction with the study PI.

CHAPTER 13: SAHELI INTERVENTION Session 1: What is a heart attack? & 3 things to talk to your doctor about
Purpose: Participants will be introduced to a heart attack, heart attack risk factors and how a heart attack can be prevented. Watch video: "What is a heart attack?" 8 minutes Video Objectives: After watching the "What is a heart attack?" video, the participant will be able to define a heart attack, understand how a heart attack happens, and explain how a heart attack can be prevented. Activity 1: The link between lifestyle, the body and a heart attack 10 minutes

Materials needed:
Objectives: The purpose of this activity is for the participant to recognize the causes of a heart attack and to differentiate between controllable and uncontrollable heart attack risk factors. The participant will also identify the lifestyle changes that can decrease the chances of having a heart attack.

Materials needed:
Other supplies  Activity 1 "cards" (five total) 1. Introduce that there are some heart attack risk factors we cannot change and some that we can change.
 Objective: The purpose of this activity is for the participant to identify barriers to taking care of their health and to inform the participants that despite these things, we will learn and work together to find ways to take care of our health throughout these sessions.
Materials needed: None 1. Introduce the participant to this activity and ask the participants about barriers to taking care of health.
 "There are many things that make it hard for us to take care of our health. Let's take a few minutes to talk about why it can be hard to take care of our health."  "What are some things that make it difficult for people to take care of their health?" If the participants are having a hard time brainstorming ideas or do not understand the question well, use weather as an example of a barrier to exercising. If the pariticpants are still having a hard time coming up barriers, ask the participants what are some things that make it difficult for them to eat healthy or exercise.
2. After the participants respond to the first question, go around the room to ask the following question:  "Do any of those things make it difficult for you?" 3. Acknowledge that there are many barriers that exisit and inform the participants that these sessions will help us find ways to take care of our health despite these barriers.
 "We do understand that there are many things that make it hard for us to take care of our health. We want you to think about these things and as you go through the classes, we will talk and learn about ways that we can take care of our health despite these things." 3. Briefly introduce next session and anything they need to prepare for next session  "At the next session we will be talking about physical activity. Please wear comfortable clothes and gym shoes at our next session as we will be doing some exercise. Please make sure to bring your folders with you to every session."

Saheli
Operations Manual 134 CONFIDENTIAL-Do not distribute, developed by Northwestern University 4. Hand out class evaluations to the participants and discuss questions that can be answered next session.
 "Before we leave, we would like for everyone to fill out this class evaluation. This will allow MAFS and Northwestern University help improve these classes."  "Also we would like for everyone to write down a question on the notepad in your folder. The questions should be about preventing heart attacks and staying healthy. For example, last time someone had heard that people in India having low cholesterol because of the warm temperature and she wanted to know more about this. Please do not include any personal health issues. We will be doing this at the end of each session because we want to make sure that everyone's questions get answered. We will collect this along with the evaluation you fill out and we will answer the questions before we start the next session." 5. Thank the participants for attending and confirm date for next session.

Session 2: Get More Exercise
Purpose: Participants will learn the benefits of exercise, amount of exercise recommended, and different ways to incorporate physical activity into their lives. Participants will also do cardio and strength resistance exercises.

Overview of materials needed for the session:
Media

Go through the responses to the questions asked last week
 "At the end of last class, we asked everyone to write down any questions that they had from that session. We will briefly review the responses to these questions." 3. Introduce the current session topic  "In this session we are going to talk about getting more exercise. Everything that we learn today will help improve our health." CONFIDENTIAL-Do not distribute, developed by Northwestern University Activity 1: Determining Heart Rate 10 minutes Objectives: The purpose of this activity is for the participant to recognize that heart rate will increase during exercise and to practice finding their pulse to determine if they are exercising at medium or fast speed.

Materials Needed:
Other supplies  Box of pens  Stopwatch Handout(s) for participants  Heart Rate During Exercise (Appendix 2A) 1. Establish that everyday chores helps keep us active but that we need to exercise 30 minutes a day at least five times a week in order to benefit our heart.
 "Doing our daily work and prayers keeps us active but to stay healthy and prevent a heart attack, we need more exercise. Can someone tell me how much exercise we need to protect our heart? (Answers should include: 30 minutes a day, 5 times a week) 2. Introduce the concept that moderate to intense physical activity is most beneficial and address South Asians concern of an increasing heart rate during exercise.
 "That's right. It is recommended to do about 30 minutes of exercise a day for five times a week. The video mentioned we should also do exercise at a medium or fast speed. What did the video say that exercise at a medium or fast speed should feel like?" (Answers should include: Your heart starts beating faster, you start to breathe a little harder, and you start to sweat lightly)  "That's right. When we exercise at a medium or fast speed, our heart will start to beat faster, we will start to breathe a little harder and we may start to sweat lightly. Some of us may be scared to exercise because our hearts start to beat faster but we want you to not be startled because it is normal for your heart to beat faster when doing exercises. If you are just starting to exercise or haven't exercised before, it is important to start slowly because our body is not used to exercise. But overtime, your body will get used to exercise." 3. Express that by determining our heart rate through finding our pulse we can make sure we are exercising at moderate intensity without overdoing it and define heart rate.
 "We want to make sure you are doing exercise at medium or fast speed that will benefit your heart. We are going to learn a simple way to make sure your heart is beating faster without beating too fast."  "In order to make sure we are doing enough exercise but not too much, we will learn what our heart rate should be when we exercise. Our heart rate is the number of times our heart beats per minute. We can know our heart rate by checking our pulse." 7. Ask each participant how many heart beats they counted and their heart rate. Explain that this is their heart rate at rest and everyone's resting heart rate will be slightly different.
 "We will go around the room and say how many beats they counted so we can determine their heart rate. This is our heart rate at rest."  "Everyone's pulse at rest will be slightly different, about 60-100 beats per minute."  "Now I will pass out a chart so that you can see what your pulse should be when you exercise." 8. Pass out the Heart Rate During Exercise handout (Appendix 2A) and pens and have the participants find their target heart rate zone during exercise.
 "On the paper, find your age. For your age, circle your target heart rate zone during exercise with a pen."  "We will be checking our pulse while we do exercise to see what our hear rate is. Our heart rate during exercise should fall between these numbers."  "If your pulse is above our zone, you need to slow down. If  1. Before leading 4-minute warm up stepping over the tape line on the ground with music. let the participants know that they can drink water if needed and to do their best in following along.
 "Now we will be doing some exercise. We have water on the side so if you need to you can get a drink. It is ok to have some water while you exercise or after you exercise. The important thing to remember is to not drink too much water or too not drink too fast."  We will be stepping over the tape that is on the ground. Try to step over the line; back and forth. We will start slow and then go to a medium and then fast speed. If it is too much for your knees, move your arms. This will help keep your heart beating. Do the best you can to follow me as we go with music." 2. Lead the 4-minute dancing workout with music.
 "Now we will be doing another exercise. I will be calling out the steps so do the best you can to follow along. If you get lost or can't follow along, just move back and forth. The important thing is to keep moving. Remember to breathe and have fun!" 3. After exercising, use the stop watch to time the participants as they check their pulse for 30 seconds to determine if they are in their target heart rate zone.
4. Ask the participants how they will feel during exercise and summarize.
 "How do you feel now compared to before exercising?"  "Right, remember, when we exercise, it is normal for our hearts to beat faster and for us to breathe a little harder. But checking your pulse will help you make sure you are doing enough exercise to benefit your heart." CONFIDENTIAL-Do not distribute, developed by Northwestern University Activity 2: Cardio exercises 10 minutes Objectives: The purpose of this activity is for the participant to perform physical activity and to check their heart rate by finding their pulse.

Materials Needed:
Other supplies  Pitcher of water  Plastic cups  Stop watch  Step stools (one for each participant)  Masking tape (already on the ground for each participant) 1. Before leading the 4-minute warm up stepping over the tape line on the ground, let the participants know that they can drink water if needed and to do their best in following along.
 "Now we will be doing some exercise. We have water on the side so if you need to you can get a drink. It is ok to have some water while you exercise or after you exercise. It is important thing to remember is to not drink too much water or too not drink too fast."  We will be stepping over the line on the ground back and forth. We will start slow and then go to a medium and then fast speed. If it is too much for your knees, move your arms. This will help keep your heart beating. Do the best you can to follow me as we go."

Lead 4-minute cardio workout
 "Now we will be doing another exercise. "Do the best you can to follow along. The important thing is to start slow and keep moving. Remember to breathe" Exercise Dynamic stretching: arms across body, arm circles and march in place 20-30 secondssquat punching left and right 10 jumping jacks 20-30 secondssquat punching left and right 10 high knees 20-30 secondssquat punching left and right 10 butt kicks 20-30 secondssquat punching left and right 10 "basketball throws" from the right 20-30 secondssquat punching left and right 10 "basketball throws" from the left Repeat sequence starting with 20-30 secondssquat punching left and right 3. After exercising, use the stop watch to time the participants as they check their pulse for 30 seconds to determine if they are in their target heart rate zone.
4. Ask the participants how they will feel during exercise and summarize.  Slide 4: "In our last activity, we learned how to use a pedometer and how we can use this to record our steps."  "We would like for everyone to try something they learned in class today. At the beginning of next class, we will talk about how it went."  "As you start to exercise, remember to wear proper shoes and to start slow and gradually increase as you get used to it. We don't want anyone to get injured or hurt." 9. Briefly introduce next session and anything they need to prepare for next session  "At the next session we will be talking about whole grains, fruits and vegetables."  "Please remember to wear you pedometer, to record your steps in the worksheet and to bring it in to the next class. We will go over them briefly before we start our next session." CONFIDENTIAL-Do not distribute, developed by Northwestern University 10. Hand out class evaluations to the participants and discuss questions that can be answered next session.
 "Before we leave, we would like for everyone to fill out this class evaluation. This will allow MAFS and Northwestern University help improve these classes."  "Also we would like for everyone to write down a question on the back of the class evaluation. The questions should be about this session. Please do not include any personal health issues. We will be doing this at the end of each session because we want to make sure that everyone's questions get answered. We will collect this when you are finished and we will answer the questions before we start the next session." 11. Thank the participants for attending and confirm date for next session.
 "Thank you for coming and we will see you next __(day of the week)__ at __(time)__."

Ask participants if they have any questions
 "Does anyone have any questions?" "Whole grains are grains that have the entire seed in one piece. The seed is made of three parts:  The seed has an outer part that protects the seed  A large part that provides energy for the seed  And a small part that provides nourishment for the seed. This small part is where the sprout comes from when a seed is soaked."

Whole grain model
Ask the participants: "White rice, which is not a whole grain, has the outer part and the small part removed. Why do you think these parts are removed?" Summarize the participants' responses:

"These two parts have been removed so the food can last longer and doesn't go bad. These two parts have the most nutrients."
Explain the benefits of whole grains for our health: "The smaller part of the whole grain contains many vitamins and minerals needed for our body and the outer part of the whole grains contains fiber. These two parts have a lot of nutrients that are beneficial for our heart and overall health which is why it is so important to eat whole grains."

Slide 14: "Quinoa (pronounced KEE-NUAW) is also similar to whole grains and it has the benefits of a whole grain. You can find quinoa at grocery stores like Jewel or Dominick's and you cook it by boiling it in water."
Emphasize eating a variety of whole grains: 1. Put olive oil in a large frying pan with mustard seeds, cumin seeds, dried red chili, asafetida, and dried curry leaves. Turn the heat up to medium and wait for the seeds to start sizzling. 2. When the mustard seeds begin to pop, pour the oil and seeds in a separate bowl. Add salt to taste and mix thoroughly. At the end of this session, participants will be able to:  Describe ways to eat less fat and salt  Identify foods high in saturated fat, trans fat, and unsaturated fat  Recognize the benefits of using oils sparingly, limiting foods high in saturated fats, and avoiding foods high in trans fat  Identify the serving size and the % Daily Value of total fat, saturated fat, and sodium amount in a packaged food

CONFIDENTIAL-Do not distribute, developed by Northwestern University
 Practice comparing fat and sodium content in packaged foods at the grocery store using the % Daily Value

Notes:
 Select a grocery store that participants frequently go to for the grocery store tour  Contact the grocery store to arrange the grocery store tour  If possible, chose a day and time that the grocery store is least busiest  If possible, arrange for transportation to travel to grocery store as a group  The closing will be completed before going to the grocery store to limit the amount of time spent at the grocery store  Class evaluations for Session 4 may be completed at home and collected at the beginning of the next session

Slide 3: "We also learned about the recommendations to eat five servings of fruits and vegetables and learned what a serving of fruits and vegetables is."
Slide 4: "Finally, we learned about the best ways to cook our vegetables and made a tasty salad."

Materials needed: None
Ask the participants if they tried anything new from the last class. Facilitate a brief discussion on barriers to trying something new and encourage the participants to problem solve and brainstorm other ways they can eat more whole grains, vegetables and fruits. Encourage the participants to try what they learned in class or to try other ways to eat more whole grains, vegetables and fruits.
Review the participants' steps recorded. Compare the steps recorded this past week from the steps recorded the first week. Provide affirmations to the participants that increased their steps. Take the time to have the participants share with one another the facilitators and barriers to increasing their steps.

Materials needed: None
Go through the responses to the questions asked last week, if any: "At the end of last class, we asked everyone to write down any questions that they had from that session. We will briefly review the responses to these questions." "The %DV is based shows that total fat is less than 65 grams, saturated fat is less than 20 grams, cholesterol is less than 300 milligrams, and sodium is less than 2,400 milligrams.

Introduce New Session
Show the one teaspoon of salt in a sandwich bag: "This amount of salt is the maximum amount of sodium you should eat in one day. It contains 2400 milligrams of sodium or 100% DV of sodium. Remember, this sodium amount comes from the salt used when cooking and from the sodium that is in packaged foods." "What is the %DV of sodium in this food?" Show the 1/10th of a teaspoon of salt in a sandwich bag: "Right, the % DV of sodium is 7%. This means that in one ounce, there is 7% of the total sodium recommended for one day. That is about how much is in this bag." Explain general guidelines to follow when readings % DV Split into groups; about two or three groups depending on the size of the class. Groups should start in different parts of the grocery store and rotate clockwise.
Below is an example of stations within a grocery store: Packaged food aisle such as packaged Indian snacks, packaged spice mixes, and jarred pickle mixes In this station, have the participants work together to pick out at least one spice package and at least one snack package that they usually buy to see how much fat, saturated fat, trans fat, cholesterol and sodium that food has.

Dairy aisle
In this station, have the participants work together to compare whole milk and skim milk, full fat yogurt and low fat yogurt, and full fat paneer and low fat paneer by reading the total fat and saturated fat on the food label.

Frozen foods aisle
In this station, have the participants work together to pick out at least one frozen vegetable bag and one frozen meal package to see how much fat, saturated fat, trans fat, and cholesterol and sodium that food has.
Note: The participants may start reading food labels of grains and dals. Explain to the participants that what we learned in class about food labels focused on sodium and different types of fats. Packaged flours and other grains and dals will have very little or no sodium or fat. The important thing to remember about grains is to choose whole grains. If time is allotted, encourage the participants to recall examples of whole grains and have the participants read atta (flour) labels to identify 100% whole grain flours.

Materials needed: None
Ask the participants if they tried anything new from the last class. Facilitate a brief discussion on barriers to trying something new and encourage the participants to problem solve and brainstorm other ways they can eat more whole grains, vegetables and fruits. Encourage the participants to try what they learned in class or to try other ways to eat more whole grains, vegetables and fruits.
Review the participants' steps recorded. Compare the steps recorded this past week from the steps recorded the first week. Provide affirmations to the participants that increased their steps. Take the time to have the participants share with one another the facilitators and barriers to increasing their steps.

Materials needed: None
Go through the responses to the questions asked last week, if any: Have the participants choose one recipe below to work in groups to modify the recipe: Here is a recipe for Upma and for Kebab. In groups, choose one of these dishes and discuss ways to modify the dish. I will give everyone about five minutes and then we will share our ideas with one another." After about five minutes, ask each group to share their ideas with the entire class. Make sure to summarize their responses: "Now I'd like for everyone to share their ideas with the class. Have the participants build a healthy plate in groups using the food models and rotis/chappattis:

"We would like everyone to get into groups to build a plate based on what you have learned in these classes and seen in the videos. This is the plate we should eat for lunch or dinner."
Pass out the plates, food models and rotis/chappattis and help the participants identify the food models if needed.
After about five minutes, ask each group to present their plates. Make sure to summarize their responses: "When we are invited to a special event or a party, it is a special occasion and it is okay to eat special foods that are a part of our culture, like samosas, pakoras, sev, gulabjaman and jilebi. But it is important to limit the amount of these foods we eat and to not overdo it. What are some ways to avoid overeating these special foods and avoid eating too much food overall?" Make sure to summarize the participants' responses: Key talking points:  Eat only one sweet or only one fried food (Control your portion sizes)  Eat something small like a fruit before leaving the house so that way you don't arrive hungry  Drink water  Eat more salad or more vegetables  Practice saying no  At a party, dance or socialize to avoid eating more food Discuss eating meals throughout the day as a way to avoid overeating: "Eating our meals throughout the day is another way to help control our weight. Why do you think this is?" Summarize the participants' responses: "Right, if we skip a meal or wait to eat one meal at the end of the day, we can become hungry and can overeat." "Spreading out our meals throughout the day will also help us get the energy and nutrients that we need during the entire day." Discuss healthy eating while fasting: "Sometimes when people fast they lose weight, stay the same or even gain weight. What are some things you can do to avoid gaining weight while you are fasting?" Summarize the participants' responses: "Right, we can watch the amount of food that we eat and focus on having vegetables, fruits and whole grains. We can still have sweets and fried foods but we want to make sure we are not eating too many of them because eating too much can lead to weight gain." Slide 14: "In the last activity, we discussed ways to avoid overeating when we eat out at restaurants and special events and ways to eat healthier to control our weight."

Review of Current Session
Encourage the participants to try something knew that they learned in today's session: "We would like for you to try something you learned in class today. We will talk about it at the beginning of next class."

Saheli
Operations Manual 217 CONFIDENTIAL-Do not distribute, developed by Northwestern University

Session 6: Take Care of Your Stress and Tension
Purpose: Participants will identify ways to cope with their stress.  "Before we begin our session on taking care of our stress and tension, we are going to review what we learned last session."

Overview of materials needed for the session
 Slide 1: "Last week, we learned about the importance of controlling our weight. We also learned that there are many things that we hear about for losing weight but that the best way to lose weight is to reduce the portions of foods, use the plate method to make half your plate vegetables, and to use a pedometer to track how many steps you take to increase walking and exercising."  Slide 2: "We then talked about ways to modify some recipes that we cook at home to make them healthier for us and our family."  Slide 3: "We also discussed ways to avoid overeating when we go to parties or other special events and ways to eat healthier to control our weight."  Slide 4: "Finally, we learned the most effective way to lose weight is to have a healthy plate with the right portions and limit the amount of fat, salt, sweets, and fried foods."  "Did anyone try something new that we learned last session?" Provide affirmations to the participants that tried something from last session. Take the time to have the participants talk about barriers to trying something new and encourage the participants to problem solve and brainstorm other ways they can eat less fat and salt. Encourage the participants to try what they learned in class or to try other ways to eat less fat and salt.

Go through the responses to the questions asked last week
 "At the end of last class, we asked everyone to write down any questions that they had from that session. We will briefly review the responses to these questions."

CONFIDENTIAL-Do not distribute, developed by Northwestern University
Watch video: "Take Care of Your Stress and Tension" 8 minutes Video Objectives: After watching the 'Take Care of Your Stress and Tension' video the participant will be able to identify ways to manage stress and to understand the relationship between stress and heart disease.  "We would like for everyone to get into groups of four. Each group will be given a stressful situation and as a group, we would like for you to work together to come up with some ways that could help these people take care of their stress and tension."  "After your discussion, one person from each group will present their scenario to the rest of the class and a different person from each group will summarize their discussion." 2. Handout the one PowerPoint slide of a scenario to each group and read their scenario example to each group.
i. Usha recently emigrated from India to the U.S. with her husband and two children.
Her husband works during the day and her children are in school. She feels sad, lonely, and tense because her family is back in India. She thinks to herself 'I can't do this; I want to go back to India.' ii. Ali's mother lives with him. His mother needs more help now because she is getting older. Ali also works during the week. Ali has been getting headaches often and is worried about his mother's health. He thinks to herself 'I am so busy and I don't think I am doing a good job at taking care of my mother.' All of this is causing a lot of stress for him.
iii. Aditi has family visiting and has to help her sister plan her wedding. She is having some family stay with her and is excited but she feels overwhelmed. She thinks to herself 'I won't be able to take care of everyone. If I can't do this well, I'm not a good sister.' iv. Deepak is late for work. His supervisor asked him to not be late next time as they need him to open the store and there are people who are waiting for him. While at work, he makes a mistake at the cash register. He feels a lot of tension and pressure and is thinking negatively. He thinks to himself 'I should have not been late, now everything is going wrong.'

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3. Give the participants 5-6 minutes to discuss the scenario as a group.
4. Have each group present their scenario and share their responses. Summarize their ideas.
 Usha is facing a lot of hardships. She is new to this country and feels lonely because she doesn't have her family nearby. Some things she can do to help take care of her tension is to get to know other people. She can take an English class or other classes at community organizations like Indo-American Center to help her meet other people who are facing a similar situation, to help her relieve her stress and to learn something new. She can volunteer or get a job, too. She can go on walks, meditate, or do yoga to help take care of her stress. Instead of thinking 'I can't do this; I want to go back to India', she can think 'I will do the best that I can' or 'I will try but I can get help if I need it.'  Ali is also facing a lot of difficulties. It is important that if he is feeling worried and stressed that he gets help and support from friends and family. Most importantly, he needs to take care of himself so he is able to care for his mother. Things he can do every day are eating healthy and eating his meals on time, making sure he gets enough sleep, doing his daily prayers and meditating. Instead of thinking 'I am so busy and feel overwhelmed; everything is going wrong', he can think 'I can handle things if I take one step at a time.'  Aditi is dealing with a lot of things all at once. Sometimes it helps to plan ahead and make a list of things that need to be done and to start with a small task. Once you accomplish this task, it can help you feel better because you are closer to the end. Sometimes, we think we can do things by ourselves but it is important to ask family and friends for help if you feel busy and overwhelmed. It is important to remember that this is a happy occasion and to give thanks instead of being upset. It is also important to think about things you've been able to accomplish in the past. Instead of thinking 'I won't be able to get all of this done. If I can't do this, I'm not a good sister', she can think 'I've been able to get over tough situations before, I can do it again' or 'I will do the best that I can.'  Deepak is having a tough day at work. Deepak may need to take a five minute break to try a relaxation technique like meditating or deep breathing. Instead of thinking 'I should have not been late, now everything is going wrong', he can think 'I won't let this problem get me down'. It's important to think positively because the negative thoughts might get in the way of getting his work done.
5. Summarize positive thinking as a way to manage stress and ask the participants if they have any questions before moving on.
 "Thinking positively is one of the ways that we talked about to help you manage stress."  "Does anyone have any questions before we move on to our last activity?" 2. Introduce telephone-support phone calls role-play to give an example of setting a goal.
 "Think about the things you learned in these classes and the things that you would like to work on. As part of the program, we will be making six phone calls to everyone in the class to help you use the information that you learned in class in your day to day life. These phone calls will last about 10-15 minutes. We will work with you to come up with a goal that you want to do and that you can do to help you improve your health." 3. Role-play to give an example of setting a goal.
 The following are examples of goals. Use one example and demonstrate setting a goal with one other person.  Eat a fruit between breakfast and lunch.  Instead of sitting down while watching TV, walk around or go up and down the stairs during commercials.  I will increase my steps from 5,000 a day to 7,000 a day in one month.  I will reduce the amount of oil for cooking by 1/3.  I will make half my plate vegetables at dinner.  I will take 5 minutes every day to meditate.  I will use my exercise bands and do the exercise band movements two times a week.

CHAPTER 14: 3 MONTH AND 6 MONTH ASSESSMENTS OVERVIEW
The second visit will include several questionnaires and procedures (i.e., anthropometry, blood pressure measurement, fasting blood collections, etc). We estimate that the complete visit will require between 1 to 1.5 hours and must be completed in one day.

General
 Anthropometry and blood collection should be performed while the participant is fasting. (If participant is not fasting, record date and time he/she last ate or drank.) Blood pressure measurement should be done before venipuncture. Questionnaires do not require fasting.  Blood drawing should be done after a minimum of a 10-hour fast and before 10:30am.

Examination Guidelines
Guidelines for second visit at 3 months are listed below:  Seated blood pressure should be done immediately following the greeting and informed consent, and before venipuncture.  Resting blood pressures should be obtained after the participant has been in the seated position for at least five minutes.  Venipuncture should be performed in the fasting state after blood pressure measurement. If a participant comes to the clinic non-fasting, exam components that do not require fasting may be completed, and then schedule the participant for another visit for fasting blood collection.  Provide a snack to participant after the blood draw.  Questionnaires and other exam procedures may be administered after the fasting blood draw. During the interviews, make every effort to avoid distractions, ensure privacy, and maintain confidentiality for the participant. Do not conduct interviews during the lunch or in the waiting area in the clinic.

Visit 2 Forms
The coordinator should check the Daily Calendar showing clinic visits scheduled for the following day. The Calendar should list the preferred language of each person scheduled for a clinic visit, which will help determine how many sets of each form is needed for the day.
Print a set of the forms that will be completed for interviews and procedures. These will be pre-printed with participant IDs, which will be matched to an individual when he/she begins the exam. Forms can be printed somewhat in advance of upcoming visits, and it is advisable to have enough printed forms on hand for all the participants. Forms will be printed in English, with the Hindi translations available. For CONFIDENTIAL-Do not distribute, developed by Northwestern University each participant, gather all the forms required for a visit, and place into a folder labeled with his/her participant ID.

Supplies and Equipment
 Make sure the accelerometers are ready and completely charged before handing out to the participants. The instructions for the accelerometer should also be printed and laminated.  Prepare the examination room for the anthropometry measurement, and seated BP.  Check all instruments that will be used for the examination e.g. Amount estimation tools, phlebotomy supplies.

Staffing
 Prepare staff assignment sheet and make sure everyone knows his/her responsibilities.

Instructions to Participants Before the Visit
Mail the Pre-Visit Instructions to the participant 5-7 days before second visit and explain to them over the telephone when you schedule the visit. If possible, make a reminder call to the participant the day before second visit and reiterate the instructions. (If the participant is acutely ill-e.g. "flu" or bronchitis-when you make this reminder call, tell him/her not to come to the clinic. Arrange to contact him/her again to reschedule when he/she has recovered.) Before the examination, make sure the participants understand the following instructions.
6. Participants must fast for at least 10 hours before the examination. This restriction applies to all food and beverages (except water), including alcohol. Instruct them to consume dinner at least 10 hours before their scheduled appointment at the clinic. Only water and prescription medications are allowed from dinner until the start of the examination the next morning. Diabetic patients should not take their hypoglycemic medications the morning of the clinic visit; they should bring the morning dose to the clinic to be taken after venipuncture.
7. Participants should not smoke on the morning of the visit.

Saheli
Operations Manual 231 CONFIDENTIAL-Do not distribute, developed by Northwestern University 8. Participants should bring all current medications, both prescription and over-the-counter, including vitamin preparations and dietary supplements, to the clinic. If the participant forgets to bring the medications, schedule another visit to obtain this information or collect the information over phone. 9. Participants should bring the name and complete address of their personal physician or health plan, particularly if they wish to have examination results sent to that provider.
10. Participants should wear or bring loose-fitting clothes, preferably t-shirt, sweat pants, and slip-on shoes or sneakers.

VISIT RECEPTION
The reception process is very important in setting the participant's frame of mind for the rest of the exam day. Greet each participant warmly as soon as he/she arrives at the clinic. (If a participant arrives at the clinic acutely ill-e.g., "flu" or bronchitis-do not continue with the clinic examination. Make arrangements to contact him/her to reschedule the appointment after he/she has recovered.)

SEATED BLOOD PRESSURE
Purpose: Blood pressure (BP) level is a major risk factor for coronary heart disease, congestive heart failure, and stroke. Heart rate reflects autonomic nervous system function and cardiovascular fitness. The measured BP level is subject to biological and observer variability.
Only study staff that are trained and certified can take blood pressure measurements for the SAHELI study.
The COPE survey helps identify the processes that people use in coping with stressful situations. In this study it will help us understand how the South Asian community copes with stressful encounters of everyday living. In a variety of studies, researchers have used it to investigate the components and determinants of coping.

Accelerometer instructions and handouts
After the completion of the questionnaires the participants will be given instructions to use the accelerometer. The accelerometers will be loaned and an appointment will be scheduled for the return of the accelerometer.
Participants will be informed that they will receive their test results when they come after one week to return the accelerometer.

Giving Participants Results of Visit Measurements and Lab Values
The participant will be given anthropometry and blood pressure results when they come to return their accelerometers, a week after the 3 month visit. The blood test from quest and physical exam results will be ready in an envelope when they are scheduled to come for their appointment for returning their accelerometer.

ALERTS AND ABNORMAL RESULTS
The purpose of defining medical alerts is to make sure that the participant and his/her physician are aware of any significant medical findings that arise as a result of the SAHELI exam.

Definitions
Alert: Any of the medical findings, listed in Table 1  If any other actions were taken or unusual circumstances were involved, please document this in the participant file.

MONTH ASSESSMENT OVERVIEW
The third visit will include several questionnaires and procedures (i.e., anthropometry, blood pressure measurement, fasting blood collections, etc). We estimate that the complete visit will require between 1 to 1.5 hours and must be completed in one day.

General
 Anthropometry and blood collection should be performed while the participant is fasting. (If participant is not fasting, record date and time he/she last ate or drank.) Blood pressure measurement should be done before venipuncture. Questionnaires do not require fasting.  Blood drawing should be done after a minimum of a 10-hour fast and before 10:30am.

Examination Guidelines
Guidelines for the third visit at 6 months are listed below:  Seated blood pressure should be done immediately following the greeting and informed consent, and before venipuncture.  Resting blood pressures should be obtained after the participant has been in the seated position for at least five minutes.  Venipuncture should be performed in the fasting state after blood pressure measurement. If a participant comes to the clinic non-fasting, exam components that do not require fasting may be completed, and then schedule the participant for another visit for fasting blood collection.  Provide a snack to participant after the blood draw.  Questionnaires and other exam procedures may be administered after the fasting blood draw. During the interviews, make every effort to avoid distractions, ensure privacy, and maintain confidentiality for the participant. Do not conduct interviews during the lunch or in the waiting area in the clinic.

Visit 3 Forms
The coordinator should check the Daily Calendar showing clinic visits scheduled for the following day. The Calendar should list the preferred language of each person scheduled for a clinic visit, which will help determine how many sets of each form is needed for the day.
Print a set of the forms that will be completed for interviews and procedures. These will be pre-printed with participant IDs, which will be matched to an individual when he/she begins the exam. Forms can be printed somewhat in advance of upcoming visits, and it is advisable to have enough printed forms on hand for all the participants. Forms will be printed in English, with the Hindi translations available. For each participant, gather all the forms required for a visit, and place into a folder labeled with his/her participant ID.

Supplies and Equipment
 Make sure the accelerometers are ready and completely charged before handing out to the participants. The instructions for the accelerometer should also be printed and laminated.  Prepare the examination room for the anthropometry measurement, and seated BP.  Check all instruments that will be used for the examination e.g. Amount estimation tools, phlebotomy supplies.

Staffing
 Prepare staff assignment sheet and make sure everyone knows his/her responsibilities.

Instructions to Participants Before the Visit
Mail the Pre-Visit Instructions (Appendix 13A) to the participant 5-7 days before 6 month visit and explain to them over the telephone when you schedule the visit. If possible, make a reminder call to the participant the day before 6 month visit and reiterate the instructions. (If the participant is acutely ill-e.g. "flu" or bronchitis-when you make this reminder call, tell him/her not to come to the clinic. Arrange to contact him/her again to reschedule when he/she has recovered.) Before the examination, make sure the participants understand the following instructions.
Participants must fast for at least 10 hours before the examination. This restriction applies to all food and beverages (except water), including alcohol. Instruct them to consume dinner at least 10 hours before their scheduled appointment at the clinic. Only water and prescription medications are allowed from dinner until the start of the examination the next morning. Diabetic patients should not take their hypoglycemic medications the morning of the clinic visit; they should bring the morning dose to the clinic to be taken after venipuncture.
Participants should not smoke on the morning of the visit.
Participants should bring all current medications, both prescription and over-the-counter, including vitamin preparations and dietary supplements, to the clinic. If the participant forgets to bring the medications, schedule another visit to obtain this information or collect the information over phone.

CONFIDENTIAL-Do not distribute, developed by Northwestern University
Participants should bring the name and complete address of their personal physician or health plan, particularly if they wish to have examination results sent to that provider.
Participants should wear or bring loose-fitting clothes, preferably t-shirt, sweat pants, and slip-on shoes or sneakers.

VISIT RECEPTION
The reception process is very important in setting the participant's frame of mind for the rest of the exam day. Greet each participant warmly as soon as he/she arrives at the clinic. (If a participant arrives at the clinic acutely ill-e.g., "flu" or bronchitis-do not continue with the clinic examination. Make arrangements to contact him/her to reschedule the appointment after he/she has recovered.) .

SEATED BLOOD PRESSURE
Purpose: Blood pressure (BP) level is a major risk factor for coronary heart disease, congestive heart failure, and stroke. Heart rate reflects autonomic nervous system function and cardiovascular fitness. The measured BP level is subject to biological and observer variability.
Only study staff that are trained and certified can take blood pressure measurements for the SAHELI study.
Procedure: Refer to Chapter 8, Blood Pressure for instructions.

PHLEBOTOMY
Purpose: To measure traditional (cholesterol, glucose, fasting sugar) risk factors for cardiovascular disease.

24 Hour Food Recall
Purpose: The 24 Hour Food Recall will record the participants' food and beverage intake of the previous day.
Procedure: Refer to Chapter 9, 24 Hour Food Recall

MEDICATIONS QUESTIONNAIRE AND MEDICATIONS INVENTORY
Purpose: At the secondvisit , participants will be asked to bring all medications that they are currently taking to the clinic, including prescription medications, over-the-counter (OTC) medications, vitamins, herbs and dietary supplements.
Procedure: Follow the directions on the data forms. 5. Record the trade name (or generic name, if necessary). If the name of the medication is longer than the number of data entry boxes on the form, just fill out as much as possible.

Filling out the MEDICATIONS QUESTIONNAIRE
6. Indicate the frequency the medication is taken. The COPE survey helps identify the processes that people use in coping with stressful situations. In this study it will help us understand how the South Asian community copes with stressful encounters of everyday living. In a variety of studies, researchers have used it to investigate the components and determinants of coping.

Accelerometer instructions and handouts
After the completion of the questionnaires the participants will be given instructions to use the accelerometer. The accelerometers will be loaned and an appointment will be scheduled for the return of the accelerometer.
Participants will be informed that they will receive their test results when they come after one week to return the accelerometer.

REPORTING OF TEST RESULTS WHEN PARTICIPANTS COME TO RETURN THE ACCELEROMETER Giving Participants Results of Visit Measurements and Lab Values
The participant will be given anthropometry and blood pressure results when they come to return their accelerometers, a week after the 6 month visit. See Appendix 12B The blood test from quest and physical exam results will be ready in an envelope when they are scheduled to come for their appointment for returning their accelerometer.

ALERTS AND ABNORMAL RESULTS
The purpose of defining medical alerts is to make sure that the participant and his/her physician are aware of any significant medical findings that arise as a result of the SAHELI exam.

Definitions
Alert: Any of the medical findings, listed in Table 1

OVERVIEW
The third visit will include several questionnaires and procedures (i.e., anthropometry, blood pressure measurement, fasting blood collections, etc). We estimate that the complete visit will require between 1 to 1.5 hours and must be completed in one day.

General
 Anthropometry and blood collection should be performed while the participant is fasting. (If participant is not fasting, record date and time he/she last ate or drank.) Blood pressure measurement should be done before venipuncture. Questionnaires do not require fasting.  Blood drawing should be done after a minimum of a 10-hour fast and before 10:30am.

Examination Guidelines
Guidelines for the third visit at 6 months are listed below:  Seated blood pressure should be done immediately following the greeting and informed consent, and before venipuncture.  Resting blood pressures should be obtained after the participant has been in the seated position for at least five minutes.  Venipuncture should be performed in the fasting state after blood pressure measurement. If a participant comes to the clinic non-fasting, exam components that do not require fasting may be completed, and then schedule the participant for another visit for fasting blood collection.  Provide a snack to participant after the blood draw.  Questionnaires and other exam procedures may be administered after the fasting blood draw. During the interviews, make every effort to avoid distractions, ensure privacy, and maintain confidentiality for the participant. Do not conduct interviews during the lunch or in the waiting area in the clinic.

Visit 3 Forms
The coordinator should check the Daily Calendar showing clinic visits scheduled for the following day. The Calendar should list the preferred language of each person scheduled for a clinic visit, which will help determine how many sets of each form is needed for the day.
Print a set of the forms that will be completed for interviews and procedures. These will be pre-printed with participant IDs, which will be matched to an individual when he/she begins the exam. Forms can be printed somewhat in advance of upcoming visits, and it is advisable to have enough printed forms on hand for all the participants. Forms will be printed in English, with the Hindi translations available. For each participant, gather all the forms required for a visit, and place into a folder labeled with his/her participant ID.

CONFIDENTIAL-Do not distribute, developed by Northwestern University
 Make sure the accelerometers are ready and completely charged before handing out to the participants. The instructions for the accelerometer should also be printed and laminated.  Prepare the examination room for the anthropometry measurement, and seated BP.  Check all instruments that will be used for the examination e.g. Amount estimation tools, phlebotomy supplies.

Staffing
 Prepare staff assignment sheet and make sure everyone knows his/her responsibilities.

Instructions to Participants Before the Visit
Mail the Pre-Visit Instructions (Appendix 13A) to the participant 5-7 days before 6 month visit and explain to them over the telephone when you schedule the visit. If possible, make a reminder call to the participant the day before 6 month visit and reiterate the instructions. (If the participant is acutely ill-e.g. "flu" or bronchitis-when you make this reminder call, tell him/her not to come to the clinic. Arrange to contact him/her again to reschedule when he/she has recovered.) Before the examination, make sure the participants understand the following instructions.
Participants must fast for at least 10 hours before the examination. This restriction applies to all food and beverages (except water), including alcohol. Instruct them to consume dinner at least 10 hours before their scheduled appointment at the clinic. Only water and prescription medications are allowed from dinner until the start of the examination the next morning. Diabetic patients should not take their hypoglycemic medications the morning of the clinic visit; they should bring the morning dose to the clinic to be taken after venipuncture.
Participants should not smoke on the morning of the visit.

CONFIDENTIAL-Do not distribute, developed by Northwestern University
Participants should bring all current medications, both prescription and over-the-counter, including vitamin preparations and dietary supplements, to the clinic. If the participant forgets to bring the medications, schedule another visit to obtain this information or collect the information over phone.
Participants should bring the name and complete address of their personal physician or health plan, particularly if they wish to have examination results sent to that provider.
Participants should wear or bring loose-fitting clothes, preferably t-shirt, sweat pants, and slip-on shoes or sneakers.

VISIT RECEPTION
The reception process is very important in setting the participant's frame of mind for the rest of the exam day. Greet each participant warmly as soon as he/she arrives at the clinic. (If a participant arrives at the clinic acutely ill-e.g., "flu" or bronchitis-do not continue with the clinic examination. Make arrangements to contact him/her to reschedule the appointment after he/she has recovered.) .

SEATED BLOOD PRESSURE
Purpose: Blood pressure (BP) level is a major risk factor for coronary heart disease, congestive heart failure, and stroke. Heart rate reflects autonomic nervous system function and cardiovascular fitness. The measured BP level is subject to biological and observer variability.
Only study staff that are trained and certified can take blood pressure measurements for the SAHELI study.

24 Hour Food Recall
Purpose: The 24 Hour Food Recall will record the participants' food and beverage intake of the previous day.
Procedure: Refer to Chapter 9, 24 Hour Food Recall

MEDICATIONS QUESTIONNAIRE AND MEDICATIONS INVENTORY
Purpose: At the second visit, participants will be asked to bring all medications that they are currently taking to the clinic, including prescription medications, over-the-counter (OTC) medications, vitamins, herbs and dietary supplements.
Procedure: Follow the directions on the data forms. 7. Record the trade name (or generic name, if necessary). If the name of the medication is longer than the number of data entry boxes on the form, just fill out as much as possible.

Filling out the MEDICATIONS QUESTIONNAIRE
8. Indicate the frequency the medication is taken. The COPE survey helps identify the processes that people use in coping with stressful situations. In this study it will help us understand how the South Asian community copes with stressful encounters of everyday living. In a variety of studies, researchers have used it to investigate the components and determinants of coping.

CONFIDENTIAL-Do not distribute, developed by Northwestern University
After the completion of the questionnaires the participants will be given instructions to use the accelerometer. The accelerometers will be loaned and an appointment will be scheduled for the return of the accelerometer.
Participants will be informed that they will receive their test results when they come after one week to return the accelerometer.

Giving Participants Results of Visit Measurements and Lab Values
The participant will be given anthropometry and blood pressure results when they come to return their accelerometers, a week after the 6 month visit. See Appendix 12B The blood test from quest and physical exam results will be ready in an envelope when they are scheduled to come for their appointment for returning their accelerometer.

ALERTS AND ABNORMAL RESULTS
The purpose of defining medical alerts is to make sure that the participant and his/her physician are aware of any significant medical findings that arise as a result of the SAHELI exam.

Definitions
Alert: Any of the medical findings, listed in Table 1  If any other actions were taken or unusual circumstances were involved, please document this in the participant file. The 6 MONTH VISIT CHECKLIST gives a suggested order of procedures for the visit. . It is highly recommended that the interviewer follow the order of the checklist for the remainder of the visit.
Procedure: Complete and check for accuracy and missing information.
Filling out the form:  Indicate participant status at the top of this form. If the interviewer is unable to contact the candidate to complete Visit 3, the interviewer must use his/her judgment to decide the appropriate time to indicate participant status as "Visit 3 scheduled but did not show."

INTRODUCTION
The purpose of the telephone support calls is to keep participants motivated to develop and achieve their goals to prevent a heart attack using the skills they learned throughout the sessions. Phone counseling will use a motivational interviewing framework to focus on self-reflection, behavior goals, and problem solving. Calls follow a semi-structured script, last about 15 minutes, and will be systematically tracked.
Individual telephone support will start two weeks after classes end. Participants will be called biweekly for eight weeks and then one call will be made every four weeks for eight weeks after the biweekly calls. A total of six calls will be made.

Telephone Support Procedure
Phone counseling will be done by the educators. The telephone calls will be audio recorded for research and training purposes. Permission for audio-recording of the telephone calls will be attained during initial visit but will not be mandatory to participate in the study.
The educator will attempt two phone calls for each scheduled telephone support call. If the educator is not able to reach the participant and complete the call during the first attempt, the educator should attempt another phone call 2-3 days later. If the educator is not able to reach the participant and complete the call during the second attempt, the educator should leave a message if possibly letting the participant know they will call them at the next scheduled telephone support call (either in two weeks or in a month) but that the participant can call them back if needed before the next scheduled telephone support call.
If requested, the participants can also receive a combination of text messages and phone calls. This option is being offered to accommodate participants' requests and reduce participant burden. The first scheduled contact will be done via telephone. Two weeks after the first phone call, the educator will send a text message to the participant to see how the participant is doing with their goal. If the participant is not able to accomplish their goal or maintain their goal and needs additional help, the educator will call the participant within 2-3 days to provide support. See diagram on the next page.
If the participant does not respond to the text message after two days, the educator will attempt to reach the participant once via telephone. If the participant does not respond to the telephone phone call, the educator can leave a message saying that they will attempt to contact them at their next scheduled contact (either in two weeks or in a month) but that the participant can call them back if needed before the next scheduled contact. If a participant notifies the educator that they will be out of town after the six sessions, then the individual telephone support calls will begin 1-2 weeks after that participant returns. If the participant still needs to attend make-up sessions for the classes they missed after the 6 th session has been completed, then the individual telephone support calls will start 1-2 weeks after that participant completes all of the make-up sessions.

During the Call
-Introduce yourself warmly -Ask if this is a good time to talk and whether the participant can speak freely -Use language easy enough for anyone to understand -Pay attention to the tone of your voice, breathing patterns pauses and speaking pace -Make an effort to understand in a non-judgmental way and be respectful -Use open-ended questions -Allow for thinking with pauses and silences as these may foster more discussion -Show you're listening by using reflective listening and verbal cues e.g. I see, yes etc.
-Compliment the participant on reaching goals and on acknowledging a need for change through affirmations -Determine participant importance, confidence and readiness to act on a goal -Strengthen the participant's self-efficacy -Avoid giving the participant information to try to convince him/her to change and avoid taking an authoritative stance -Ask permission to make suggestions if the participant is struggling in developing their goals -Guide the participant in making a SMART (Specific, Measurable, Achievable, Realistic, Timely) goal

Ending the Call
-Summarize the main points of the conversation once the participant has identified and stated their SMART goal -Set a time for the next scheduled phone call with the participant -Thank the participant for taking the time to talk to you

USING MOTIVATIONAL INTERVIEWING DURING PHONE CALLS
Open questions, affirming, reflecting and summarizing (OARS) are the primary skills necessary to practice motivational interviewing. These skills get the participant talking. More importantly, these skills encourage the participant to explore their ambivalence to change and clarify reasons for change. Instead of the educator advocating for change, which often puts the participant in the position of defending against it, motivational interviewing takes a different approach. The idea is to have the educator facilitate the participant's expression of change talk, that is, for the participant to present the arguments for change. The general pattern in motivational interviewing is to ask an open question, setting the topic of exploration, and then follow with reflective listening, affirmations and summarizing. Avoid asking three questions in a row. Reflective listening is not just restating what the participant said, but capturing their feelings about the facilitators and barriers to change.
Eliciting and Responding to Change Talk Change talk is any participant speech that favors movement in the direction of change. Eliciting change talk is a strategy that gets participants to identify and give voice to the need or reasons for changing. Rather than the educator lecturing or telling participants the importance of and reasons why they should change, change talk comes from the participant.
The educator should be able to identify statements of change talk. Change talk falls into four general categories: Recognizing disadvantages of the status quo (current situation)  "I guess there's more of a problem here than I realized."  "I never really thought that much before about how this affects my family"  "This is serious"  "Maybe I have been taking foolish risks"  "I can see that in the long run, this is going to do me in if I don't make a change." When the educator hears change talk, the educator should be particularly interested and attentive. Once a reason for change has been named by the participant, it is important to respond to it. The educator can use the acronym EARS: elaborating, affirming, reflecting, and summarizing to respond to change talk. Ways for asking for elaboration include asking for clarification, asking for a specific example, or using straightforward encouragement to have the participant continue.  In what ways? When?  Give me an example. Use reflections selectively to reinforce change talk and keep the conversation moving in the direction of change. Occasionally a reflection will evoke resistance (often if it is too strong). In this case, the educator can recover with a double sided reflection. Summarizing can also be used selectively. The educator can affirm change talk.
 That's a good point  That sounds like a good idea  I think that could work  I can see how that would concern you Enhancing Confidence Self-efficacy is the participant's belief or confidence in one self that he/she has the ability to succeed in reaching a specific goal. Self-efficacy is one of the most important determinants of whether behavioral change takes place, because unless people believe that they can produce desired effects by their actions, they have little incentive to act for behavioral change. The desire to change is the degree of perceived discrepancy between status and goal, between what is happening at present and what one values for the future but people cannot be ready to change until they perceive both that they want to and are able to do so.
Self-efficacy also affects whether people mobilize the motivation and perseverance needed to succeed, and finally their ability to recover from failures and relapses, and how well they continue their behavior changes once their goals have been achieved.
The following strategies can be used to strengthen the participant's self-efficacy: 1. Evocative Questionsthese are open questions that are used to evoke confidence talk  How might you go about making this change?"  What would be a good first step?  What obstacles do you foresee, and how might you deal with them?  What gives you some confidence that you can do this?
2. Using the confidence ruler  How confident are you that you could ___________? On a scale from 0 to 10, where 0 is not at all confident and 10 is extremely confident, where would you say you are?  Why are you at a _____ and not a 0? What would it take for you to go from _____ to [a higher number]?
3. Reviewing past successes  When in your life have you made up your mind to do something and did it? It might be something new you learned or a habit that you quit, or some other significant change that you made in your life. When have you done something like that?  What did the client do that worked? Was there specific preparation for change? Look for personal skills or strengths that might be generalized and applied in the current situation. What did the person do to initiate and maintain change? What obstacles were there, and how did he or she surmount them?

Personal strengths and support
 What is there about you, what strong points do you have that could help you succeed in making this change?  When the client identifies a personal strength, ask for elaboration and examples and follow with reflective listening  Also explore sources of social support the client has for pursuing change. Are there others on whom he or she could call for support? In what ways? Who else could help with change?
5. Brainstormingthis involves freely generating as many ideas as possible for how a change might be accomplished. This list is generated without critiqueall ideas are acceptable, no matter how silly or unrealistic they might seem. It is OK to suggest ideas here, but mostly you should rely on the participant's creativity and what they recall from the classes to generate possibilities. Once a list has been generated, ask the client which ideas on the list seem most promising or acceptable and why.
6. Giving information and advice -The educator should ask for permission to give some ideas:  I spoke with a participant who dealt with a similar problem; would it be ok if I share some information with you about how to approach ______?  There is one thing we learned in class that I think could help you _____________; is it ok if I share this with you?
7. Reframing -For participants who focus on the failure, the educator should reframe failure in a way that encourages rather than blocks further change attempts. The concept of 'try' can be useful. Explanations of failure as being due to internal, stable factors like inability can be reattributed to external and unstable factors like effort or luck:  The time wasn't right.  I wasn't quite ready.  I was unlucky that time.  I didn't try hard enough, or long enough.  Maybe next time is my time.
8. Hypothetical changeif the person is struggling with practicalities, it may be helpful to use hypotheticals:  Suppose that you did succeed and are looking back on it now: What most likely is it that worked? How did it happen?  Suppose that this one big obstacle weren't there. If that obstacle were removed, then how might you go about making this change?  Clearly you are feeling very discouraged, even demoralized about this. So use your imagination: if you were to try again, what might be the best way to try?
If the participant faces complex barriers related to limited economical resources, lend hope and continue to enhance confidence using the above-mentioned strategies and affirmations:  I certainly don't have the answers for you, but I have a lot of confidence that you do, and that working together we can find a way.

Setting a SMART goal
A SMART goal is defined as one that is specific, measurable, achievable, realistic, and timely. Setting small SMART goals that the participant will be able to achieve will help build the participant's selfefficacy. Higher outcome expectations are stronger motivators; however, unrealistic, unattainable outcome expectations may discourage participants to continue. The following questions can be used to help the participants set a SMART goal:  What would you say your goal is between now and next time we talk?  How often would you do this to get a good outcome?  How often would you need to do this?  How much time do you need to achieve that?  Will that give you enough time to get started?
If a participant selects a goal that is not realistic, consider using the confidence scale or ask specific questions to determine if the SMART goal may need to be modified.  What would it take for you to go from _____ to [a higher number]?  What are some things that could make it challenging for you to accomplish your goal?  If ______ happened, how would it affect you from accomplishing your goal?
If a participant is having trouble coming up with a SMART goal, ask for permission to give suggestions.  In class, we learned that we should start slow when doing exercises to avoid injuries. What are your thoughts about reducing the amount of exercise you would like to do to avoid injuries?  I spoke with another participant who also wanted to work on _________. Would you mind if I share with you her ideas on how to accomplish __________?

Identifying Stages of Change
It can be important for the educator to identify the participant's stage of change and provide support according to the stage in order to minimize resistance to behavior change. See Table 2 for examples. The majority of the participants for this study will be in the contemplation, preparation and action stage mainly because the participants have at least one heart attack risk factor and because they have knowledge from the classes on heart attack prevention and therefore they may be more willing and able to make the appropriate changes. It is important for the educator to know that a participant could alternate between stages and go back and forth. As the phone calls progress, the educator should increase awareness regarding these normal fluctuations in acquiring change.
If the participant reports that they are doing the things that were taught in class, the participant is in the action stage. Provide support and encouragement for these participants, however, it is important to assess if the participant is truly taking action and working towards a goal or if the participant is saying they are taking action for approval. Determine if the participant can sustain the changes made. If the participant needs help with maintenance, highlight self-efficacy by reinforcing effort not ability and work with the participant to modify and set a SMART goal. Build on existing achievements when setting a new goal.
Participants that report no need for change are in the pre-contemplation stage. If the participant is at this stage, the educator should explain that the decision is theirs to make changes. The educator should encourage re-evaluation and provide support in gathering additional information or reviewing concepts from the sessions if the participant agrees. The educator should let the participant know that they are available to talk when they are ready.

Progressing Well With Goal
If the participant is progressing well with their goals, highlight their self-efficacy:  "Even when a goal seemed difficult, you were able to follow through".
. As the participant is explaining their success, find out what is going well and use that to craft affirmation. Give plenty of affirmations for goal directed attempts and actions:  "You've discovered that doing ___________ helps you feel healthier!"  "If someone else was just getting started with this, what would you tell them?"  "What would you tell your 8-weeks-ago-self about this?" Congratulate the participant on their success but determine if the participant can sustain change by asking:  "Where does _____________ fit into the future?"  "What can you do to ensure you maintain this change?"  "How will you be able to monitor your change?" Continue to enhance the patient's self-efficacy as this will help increase their ability to recover from failures and relapses to sustain behavior changes once their goals have been achieved.
To see if the participant is interested in tackling another goal, ask:  "What are your next steps towards improving your health?"  "What else would you like to work on to improve your health?" If you can't build motivation for new things, go back to what worked in the past. In this case, discuss whether to attempt to maintain some previous changes rather than continue adding new things.

Difficulty Achieving Goal
If the participant is having difficulty achieving a goal, explore the issue and understand why. Assess barriers by asking open-ended questions like:  "What has been getting in the way?"  "Setting a time for _____________ didn't work out. I'd like to get a sense of what was going on", "What do you imagine you would get out of the activity?"  "I wonder if you're not finding this very helpful or if you're feeling discouraged." If people are facing a daunting task, their instinct may be to avoid it, so you should work with the participant to break down the task. Re-evaluate and modify the SMART goal with the participant to make sure it is a small and visible goal.
Make an effort to remind the participant about the challenges they have already overcome. Do this through affirmations that focus on goal directed attempts.
 "You seem to be comfortable with removing salt from the table and adding a vegetable to your meals, but on the other hand, you notice your pants have been fitting tighter. I wonder if you might have more success with weight loss by trying something different. What do you think of that?" Consider using the aforementioned strategies to elicit change talk to re-explore benefits of continuing to try a new skill.
Try to get the participant's agreement to continue trying the skill without forcing it on them:

CHAPTER 16: LAB PROCEDURES OVERVIEW
The blood sample will be drawn at the baseline, 3 month and 6 month visit after 10 or more hours of fasting.

EQUIPMENT AND SUPPLIES
Quest diagnostics will provide the following supplies in bulk by emailing Drew Kelley The supplies that can be ordered from Quest are  Blood collection tubes: -4 mL EDTA plasma tubes (BD 367862 or 367844) -7 mL gel-topped serum tubes (BD 367977 or 367812)  Tourniquets (quick-release tourniquet is recommended; please do not use blood pressure cuff)  Vacutainer barrels  Alcohol prep pads MAFS blood collection area should have the following supplies:  Lab coats and gloves  Phlebotomy chair  Plastic cart with wheels (or plastic tray with compartments) for supplies  Blood tube rack  21 gauge Butterfly needles with luer adapter (BD #7251)  Participant ID labels (already labeled on appropriate tubes)  Pens  Band-Aids  Gauze (2x2-inch)  Blood spill kit  Biohazards waste container (for needles/sharps)  10% bleach solution or approved biohazard disinfectant

PROCEDURES Safety Issues and Precautions for Handling Blood and Urine Specimens
In accordance with the OSHA regulations on bloodborne pathogens recommends the following laboratory safety protocol for the sites: and several other procedures (weight, anthropometry, OGTT) for the clinical visit will need to be omitted.  Negative result: please inform the participant.

Preparation
Make sure venipuncture supplies are stocked (see EQUIPMENT & SUPPLIES). Make sure tubes are labeled.
Make sure the phlebotomy room is tidy and stocked with all items needed,

Phlebotomy Room
The blood draw is done in an isolated room, or participants are separated by room dividers. The room is equipped with all of the necessary blood drawing supplies (see EQUIPMENT & SUPPLIES).

Participants
This study depends on and requires the voluntary cooperation of the participants. These people are giving their timeand precious bodily fluidsand their only reward is the knowledge that they are contributing to progress in medicine. Thus, the experience must be as pleasant as possible. Give the participant enough time to feel comfortable, both before and after the blood collection. In many cases the most memorable part of the experience for the participant will be contact with, and the attitude and competence of, the technician who draws the blood. Do not under any circumstances force or coerce the participant to have blood drawn.

Draw Tubes
Correct labeling and accurate tracking of collected specimens is vital, and correct draw tube order is important. Setting up pre-labeled draw tubes in a blood collection tube rack prior to the participant's arrival is recommended. A maximum of 12 mL of blood will be collected from each participant into 2 draw tubes. There are no additional tubes collected specifically for quality control purposes.

Participant Preparation
We require the participant to abstain from all food and drink (except water and prescription medications) for a minimum of 8 hours prior to clinic visit. Please contact the participant (phone, mail, e-mail) with the following information as close to the visit as possible:  Do not eat or drink anything but water for at least 8 hours before the visit (but not longer than 18 hours).  Drink plenty of water.  Do not drink alcohol for 36 hours before the visit.  Do not smoke the morning of the visit.  Do not engage in vigorous physical activity 8 hours prior to the visit.  Prescription medications may be taken with a sip of water that morning  Do call to reschedule the appointment if you have been ill during the previous seven days before the visit. Illness is defined as a cold, flu, fever, or any physical stress that in the opinion of the investigator may affect the blood glucose of the participant. Seasonal allergies would not be considered an illness.
The visit may need to be rescheduled if the above requirements are not met (see specific guidelines below).
The following conditions would prohibit the completion of the OGTT:  Illness within the past 7 days  Fasted < 8 hours or > 18 hours  Has not had typical or usual diet over the past 3 days  Exercised within the past 8 hours  Smoked morning of test (within 1 hour of test)

ALWAYS WEAR NITRILE OR LATEX GLOVES AND LAB COAT
Blood drawing is standardized for the sitting position. You may have participants clench their fists (moderately) during phlebotomy, for up to two minutes. Venipuncture is performed with a 21-gauge butterfly needle with 12 inches of plastic tubing between the venipuncture site and the blood collection tubes. The butterfly has a small, thin walled needle that minimizes trauma to the skin and vein. Using 12 inches of tubing allows tubes to be changed without any movement of the needle in the vein.
Step-bystep procedures are as follows: If the participant faints, use smelling salts to revive by crushing the ampoule and waving it under the nose for a few seconds.
If the person continues to feel ill, contact a medical staff member for advice.
 If all tubes are not collected (blood flow ceases, difficult venipuncture, etc.), make a note of the difficulties on the VISIT CHECKLIST in the Comment section for future reference. If the participant is willing, another attempt should be made to complete the draw, collecting only those tubes that were not filled in the first attempt.