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

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

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.

Study Overview

• Status: Completed
• Conditions: Pre-diabetes
• Intervention / Treatment: Behavioral: DPP; Behavioral: DPP Cooks

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 45
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Maryland
    • Baltimore, Maryland, United States, 21205
      • Brancati Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change From Baseline in Absolute Body Weight (Kilograms (kg))	Weight change will be measured in absolute kg. 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
Change From Baseline in Percentage of Baseline Bodyweight	Weight change will be measured in the percent of body weight change. 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 of dietary intake 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.	Baseline and at 4 months
Change From Baseline in Cooking Confidence	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. Survey items were based on prior literature, but there is not a formal named scale that was used. Cooking confidence was assessed by 7 items all measured on a 7 point Likert scale. Negative items were reverse coded, then 7 confidence items were summed to create a overall confidence score (range 7-49) with higher values indicating higher confidence.	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 question 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 (after reverse coding negative items) 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. In this sample scores range from 10.48- 22.25 points with higher scores indicating better Food Agency.	baseline, 4 months and 12 months
Participant 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
Change From Baseline in Cooking Attitudes	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. Survey items were based on prior literature, but there is not a formal named scale that was used. Attitudes were assessed by 11 questions all scored on a 7 point Likert scale. Negative attitudes were reverse coded, then scores were summed across all 11 items to create an overall Attitudes score (range: 7-77) with higher scores indicating more positive attitudes about cooking.	baseline, 4 months and 12 months
Change From Baseline in Cooking Behavior (Days Cooking Dinner)	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. To assess behavior change, an item from the National Health an Nutrition Examination Survey (NHANES) assessing frequency of cooking dinner was used. Change in number of days (0-7) cooking is reported with higher numbers indicating more frequent cooking dinner at home.	baseline, 4 months and 12 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Program Attendance Among DPP and DPP Cooks Participants	DPP coaches will report weekly session attendance for all trial participants. Attendance at a higher number of sessions will be a favorable result.	12 months
Program Satisfaction Among DPP Cooks Participants (Qualitative)	Investigators will use interviews or focus groups with DPP Cooks participants to gather qualitative feedback about program satisfaction among participants	12 months

Collaborators and Investigators

• Sponsor: Johns Hopkins Bloomberg School of Public Health
• Collaborators: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
• Investigators: Principal Investigator: Julia A Wolfson, PhD, Johns Hopkins Bloomberg School of Public Health

Study record dates

Study Major Dates

• Study Start (Actual): February 2, 2022
• Primary Completion (Actual): October 4, 2023
• Study Completion (Actual): October 4, 2023

Study Registration Dates

• First Submitted: December 8, 2021
• First Submitted That Met QC Criteria: December 8, 2021
• First Posted (Actual): December 22, 2021

Study Record Updates

• Last Update Posted (Estimated): November 22, 2024
• Last Update Submitted That Met QC Criteria: November 6, 2024
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Endocrine System Diseases; Metabolic Diseases; Glucose Metabolism Disorders; Diabetes Mellitus; Prediabetic State
• Other Study ID Numbers: IRB00018839; K01DK119166 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No