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

NCT05166512 | Completed Results

• 2 other identifiers: IRB00018839K01DK119166
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

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.

Conditions

Pre-diabetes

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (6)

• Difference From Baseline in Diet Quality (Healthy Eating Index- 2015) Score

  Baseline and at 4 months

• Change From Baseline in Cooking Confidence

  baseline, 4 months and 12 months

• Change From Baseline in Food Agency Measured Via the Cooking and Food Provisioning Action Scale (CAFPAS)

  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

  baseline, 4 months and 12 months

• Change From Baseline in Cooking Attitudes

  baseline, 4 months and 12 months

Other Outcomes (2)

• Program Attendance Among DPP and DPP Cooks Participants

  12 months

• Program Satisfaction Among DPP Cooks Participants (Qualitative)

  12 months

Study Arms (2)

Standard DPP

ACTIVE COMPARATOR

Standard DPP (over 12 months)

Behavioral: DPP

DPP Cooks

EXPERIMENTAL

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

Behavioral: DPP Cooks

Interventions

DPP Cooks BEHAVIORAL

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

DPP Cooks

DPP BEHAVIORAL

Standard DPP

Standard DPP

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Johns Hopkins Bloomberg School of Public Health: lead
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator

Study Sites (1)

Brancati Center

Baltimore, Maryland, 21205, United States

Location

MeSH Terms

Conditions

Glucose Intolerance

Condition Hierarchy (Ancestors)

Hyperglycemia; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Results Point of Contact

• Title: Dr. Julia Wolfson
• Organization: Johns Hopkins Bloomberg School of Public Health

jwolfso7@jhu.edu

410-614-4907

Study Officials

• Julia A Wolfson, PhD

  Johns Hopkins Bloomberg School of Public Health

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 8, 2021
• First Posted: December 22, 2021
• Study Start: February 2, 2022
• Primary Completion: October 4, 2023
• Study Completion: October 4, 2023
• Last Updated: November 22, 2024
• Results First Posted: November 7, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)