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Table 2 Study Outcomes

From: Cooking for Health: a healthy food budgeting, purchasing, and cooking skills randomized controlled trial to improve diet among American Indians with type 2 diabetes

 

Definition

Operationalization

Details

Primary outcomes

Sugar-Sweetened Beverages

Change (from baseline) in self-reported intake (servings/day) of sugar-sweetened beverages

Sugar-sweetened beverages include self-reported intake of fruit drinks, sugar-based energy drinks, and soda. Intake of sugar-sweetened beverages will be estimated using measures of consumption frequency and portion size. Average intakes will be calculated for each study participant using the University of Minnesota Nutrition Data Systems for Research Software by multiplying the frequency response for each beverage on the food frequency questionnaire by the recalled portion size, and then summing for all relevant beverages.

Change from baseline with be assessed at 6 months and 12 months (12 months - baseline; 6 months - baseline). As the intervention hopes to decrease intake of sugar-sweetened beverages, lower (i.e., more negative) after - before differences represent a better outcome.

Nutrition Assessment Shared Resource Food Frequency Questionnaire [23]

Healthy and unhealthy food purchases

change (from baseline) in healthy and unhealthy food purchases

Change in healthy and unhealthy food purchases will be estimated using the Healthy/Unhealthy Food Acquisition Survey. The survey includes a list of 47 healthy and unhealthy foods commonly consumed in the community. At each exam (baseline, month 6, month 12), participants will report the number of times he/she acquired each of the 47 foods in the past 30 days.

Change from baseline with be assessed at 6 months and 12 months (12 months - baseline; 6 months - baseline). As the intervention hopes to increase the number of healthy food purchases and decrease the number of unhealthy food purchases, higher after - before differences represent a better outcome for healthy foods and lower after - before differences represent a better outcome for unhealthy foods.

The Healthy/ Unhealthy Food Acquisition Survey is a modified version of Dr. Gittelsohn’s Healthy and Unhealthy Food Getting Questionnaire [28]

Secondary outcomes

Food Budgeting Skills

change (from baseline) in food budgeting skills

Change in food budgeting skills will be estimated using the Food Resource Management Scale. The scale includes 4 questions related to shopping behaviors to maximize food resources. The Food Resource Management Scale is a Likert-type scale with responses ranging from 1 (never) to 5 (always). Responses to the four questions will be averaged to create a total Food Resource Management Score.

Change from baseline with be assessed at 6 months and 12 months (12 months - baseline; 6 months - baseline). As the intervention hopes to increase food budgeting skills, higher after-before differences represent a better outcome.

The Food Resource Management Scale utilizes 4 questions derived (and adapted for clarity/readability) from Cooking Matters surveys on food resource management [11, 12]

Cooking Skills

change (from baseline) in cooking skills

Change in cooking skills will be estimated using a minor modification to the Cooking Confidence Scale. The Cooking Confidence Scale includes 6 questions related to confidence in preparing healthy foods. It is a Likert-type scale with responses ranging from 1 (not at all confident) to 5 (very confident). Responses to the questions will be averaged. Change from baseline with be assessed at 6 months and 12 months (12 months - baseline; 6 months - baseline). As the intervention hopes to increase cooking skills, higher after - before differences represent a better outcome.

The Cooking Confidence Scale was modified such that one of the six questions from the Cooking Confidence Scale in Cooking Matters [11, 12] was broken up into multiple parts for ease of readability in a low literacy population.

Process Evaluation Endpoints (Secondary)

Intervention Reach

 

The proportion of those approached that participate in intervention (and the number who subsequently participate) will be used as a marker of intervention reach.

 

Intervention Fidelity

 

The investigators will assess adherence to the study protocol and document barriers and facilitators to implementation throughout the trial.

 

Intervention Satisfaction

 

During the in-person visits at months 6 and 12, a sub-sample of study participants in the intervention arm will meet with study staff for semi-structured interviews to evaluate the overall intervention. Qualitative analyses will assess participant’s satisfaction with the intervention.

 

Intervention Dose

 

Dose delivered: number of lessons included in the curriculum available for participants

Dose received: Number of lessons included in the curriculum completed by participants Dose will be assessed in the intervention arm only

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