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

NCT ID: NCT05166512

Last Updated: 2024-11-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 45 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-02-02
• Study Completion Date: 2023-10-04

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.

Conditions

Pre-diabetes

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Standard DPP

Standard DPP (over 12 months)

Group Type: ACTIVE_COMPARATOR

DPP

Intervention Type: BEHAVIORAL

Standard DPP

DPP Cooks

Standard DPP plus DPP Cooks (over 12 months, with 6 active cooking sessions during the first 4 months)

Group Type: EXPERIMENTAL

DPP Cooks

Intervention Type: BEHAVIORAL

6 'food agency' based cooking skills classes during the first 4 months of the DPP

Interventions

DPP Cooks

6 'food agency' based cooking skills classes during the first 4 months of the DPP

Intervention Type: BEHAVIORAL

DPP

Standard DPP

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

NIH

Sponsor Role: collaborator

Johns Hopkins Bloomberg School of Public Health

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Julia A Wolfson, PhD

Role: PRINCIPAL_INVESTIGATOR

Johns Hopkins Bloomberg School of Public Health

Locations

Brancati Center

Baltimore, Maryland, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

K01DK119166

Identifier Type: NIH

Identifier Source: secondary_id

View Link

IRB00018839

Identifier Type: -

Identifier Source: org_study_id