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

Pre-diabetes Clinical Trial

— DPPCooks  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05166512
• Other study ID #: IRB00018839
• Secondary ID: K01DK119166
• Status: Completed
• Phase: N/A
• Start date: February 2, 2022
• Est. completion date: October 4, 2023

Study information

• Verified date: October 2023
• Source: Johns Hopkins Bloomberg School of Public Health
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 43
• Est. completion date: October 4, 2023
• Est. primary completion date: October 4, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Pre-diabetes
• Prediabetic State

Intervention

Behavioral:
• DPP Cooks
6 'food agency' based cooking skills classes during the first 4 months of the DPP
• DPP
Standard DPP

Locations

Country	Name	City	State
United States	Brancati Center	Baltimore	Maryland

Sponsors (2)

Lead Sponsor	Collaborator
Johns Hopkins Bloomberg School of Public Health	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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