Pilot Trial of a Novel Cooking Skills Intervention (DPPCooks) to Prevent Diabetes

Study Overview
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Brief Summary
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In this pilot trial participants will be randomized 1:1 to participate in either standard Diabetes Prevention Program (DPP) vs. DPP plus a novel cooking skills intervention (DPP Cooks). The researchers hypothesize that participants randomized to DPP Cooks will have greater weight loss, better diet quality at 4 months, and greater confidence in their cooking skills and ability to implement dietary changes recommended in the DPP.

Detailed Description
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This study is a randomized pilot trial testing a novel cooking skills intervention (DPP Cooks) vs. the standard Diabetes Prevention Program (DPP). The DPP is a widely disseminated evidenced-based lifestyle behavior change program to help adults with pre-diabetes lose weight and prevent type-2 diabetes. In this trial the investigators will test whether the addition of food-agency based cooking skills classes improves the effectiveness of the DPP. This trial will take place in Baltimore, MD in collaboration with community partner DPP providers. The trial has been informed by formative work with prior DPP participants and has used a Community Based Participatory Research (CBPR) approach to developing the DPP Cooks intervention. Participants will be randomized 1:1 to participate in either standard DPP vs. DPP Cooks. The length of the trial will be 12 months and outcomes will be measured at baseline, 4 months, and 12 months.

Official Title
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Development and Pilot Evaluation of a Novel Cooking Skills Intervention to Prevent Diabetes

Conditions
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Pre-diabetes

Intervention / Treatment
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* Behavioral: DPP Cooks
* Behavioral: DPP


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adults in Baltimore City eligible for DPP based on Centers for Disease Control guidelines possession of a smart phone with camera can commit to 12 month study participation Exclusion Criteria: current or prior diagnosis of type 1- or type 2 diabetes non-English speaker participating in another research study that may effect diabetes, diet, or weight loss currently pregnant

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Standard DPP<br>Standard DPP (over 12 months) | Behavioral: DPP<br>* Standard DPP<br>|
| Experimental: DPP Cooks<br>Standard DPP plus DPP Cooks (over 12 months, with 6 active cooking sessions during the first 4 months) | Behavioral: DPP Cooks<br>* 6 'food agency' based cooking skills classes during the first 4 months of the DPP<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in body weight (kilograms (kg) and percent of baseline bodyweight) | Weight change will be measured in absolute kg and in the percent of body weight lost. Weight will be measured at baseline, 4 months and 12 months. Weight will be measured by DPP coaches at weekly meetings (or, if DPP groups are meeting virtually, weight will be reported by participants to their DPP coaches in weekly virtual meetings). | baseline, 4 months and 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Difference from baseline in diet quality (Healthy Eating Index- 2015) score. | Dietary intake and diet quality (Healthy Eating Index (HEI-2015) as measured by the Remote Food Photography Method (RFPM) over 3 days at baseline and 4 months. The HEI-2015 is a score from 0-100 with high score indicating better diet quality. The HEI-2015 measures how well an individuals dietary intake aligns with the 2015 US Dietary Guidelines. | 3 days of dietary intake data at baseline and at 4 months | 
| Change from baseline in cooking confidence, attitudes, and behavior | Cooking confidence, attitudes and behaviors will be measured via online survey (7- point Likert Scale (strongly agree to strongly disagree) questions) at baseline, 4 months and 12 months. | baseline, 4 months and 12 months | 
| Change from baseline in Food Agency measured via the Cooking and Food Provisioning Action Scale (CAFPAS) | The Cooking and Food Provisioning Action Scale (CAFPAS) is a 28 questions scale in which higher scores indicate higher Food Agency. All questions in the CAFPAS are measured on 7-point Likert Scales (strongly agree to strongly disagree). The CAFPAS has 3 sub-scales which are scored by summing the scores on each individual question and are then standardized. Then the 3 standardized sub-scale scores are summed to generate an overall CAFPAS score in which higher scores indicate better Food Agency. | baseline, 4 months and 12 months | 
| Change from baseline in food security status over the past 30 days using the 10-item United States Department of Agriculture (USDA) adult food security survey module | The USDA Adult Food Security Survey Module is a 10-item progressive survey instrument in which individuals are asked about the food situation in their household over the last 30 days. Scores are summed and generate the following categories: High food security status (raw score: 0), Marginal food security status (raw score: 1-2), Low food security status (raw score 3-5), Very low food security status (raw score: 6-10). | baseline, 4 months and 12 months |