Clinical trial NCT05166512: Pilot Trial of a Novel Cooking Skills Intervention (DPPCooks) to Prevent Diabetes
Official title: Development and Pilot Evaluation of a Novel Cooking Skills Intervention to Prevent Diabetes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pre-diabetes
Lead sponsor: Johns Hopkins Bloomberg School of Public Health
Sponsor class: OTHER
Collaborators: name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
First posted: 2021-12-22
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change From Baseline in Absolute Body Weight (Kilograms (kg))
timeFrame: baseline, 4 months and 12 months
measure: Change From Baseline in Percentage of Baseline Bodyweight
timeFrame: baseline, 4 months and 12 months
Secondary outcomes:
measure: Difference From Baseline in Diet Quality (Healthy Eating Index- 2015) Score
timeFrame: Baseline and at 4 months
measure: Change From Baseline in Cooking Confidence
timeFrame: baseline, 4 months and 12 months
measure: Change From Baseline in Food Agency Measured Via the Cooking and Food Provisioning Action Scale (CAFPAS)
timeFrame: baseline, 4 months and 12 months
measure: Participant Food Security Status Over the Past 30 Days Using the 10-item United States Department of Agriculture (USDA) Adult Food Security Survey Module
timeFrame: baseline, 4 months and 12 months
measure: Change From Baseline in Cooking Attitudes
timeFrame: baseline, 4 months and 12 months
measure: Change From Baseline in Cooking Behavior (Days Cooking Dinner)
timeFrame: baseline, 4 months and 12 months
Other outcomes:
measure: Program Attendance Among DPP and DPP Cooks Participants
timeFrame: 12 months
measure: Program Satisfaction Among DPP Cooks Participants (Qualitative)
timeFrame: 12 months
Locations:
city: Baltimore
country: United States
facility: Brancati Center
state: Maryland
Study officials:
affiliation: Johns Hopkins Bloomberg School of Public Health
name: Julia A Wolfson, PhD
role: PRINCIPAL_INVESTIGATOR
References: