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Table 3 Measurement protocol in the Fresh Start study

From: Fresh Start, a postpartum weight loss intervention for diverse low-income women: design and methods for a randomized clinical trial

Measure

Assessment approach/tool

Weight/BMI

Measured with the individual wearing light clothing and no shoes using portable digital scales and stadiometers

Waist circumference

Measured twice (and averaged) with a non-stretchable measuring tape using standard methodology

Blood pressure

Measured three times over 60–90 min in a standardized manner [42], after several minutes of quiet sitting with a Dinamap XL automated BP monitor [43]

Physical activity

The Pregnancy Physical Activity Questionnaire [44]

Diet and Eating Behaviors

NCI computerized 24 h recall [45], Three-Factor Eating Questionnaire, Weight Behavior Inventory [46]

Other behaviors

Pittsburgh Sleep Quality Index [47], daily weighing, Behavioral Risk Factor Surveillance System tobacco use questions, CAGE alcohol screening questionnaire

Psychosocial

Edinburgh Postnatal Depression Scale [48], Perceived Stress Scale [49], Delaying Gratification Index (food questions), perceived weight status (investigator developed), family social support for weight loss (investigator-developed)

Socio-demographics

Education, income, employment, race/ethnicity, age, marital status, living situation, number of children, smoking, weight history, parity, breastfeeding and chronic conditions.

Reach

Number, percentage and representativeness of women who participate in the study, including recruitment and retention rates and attendance at intervention sessions.

Adoption

Counts of uptake of the intervention by new WIC clinics after the research study, assuming effectiveness

Implementation

Intervention delivery: fidelity to intervention delivery using a standardized checklist with comments completed by research staff

Costs: materials costs and time required to deliver both conditions tracked using a log of study-related expenses, which will be summarized by category (e.g. staff time, food costs, materials, etc.)

Utilization, or dose received: participant attendance counts for group and follow-up phone call session attendance; surveys at follow-up sessions for print material use and YWCA use

Maintenance

WIC clinics program delivery: maintenance of the intervention beyond the research funding, including where and to whom the intervention was delivered for a period of 2 years

Participant behaviors: weight change at 12 month follow-up assessment