Addressing Food Access and Physical Activity to Improve Diabetes Prevention Outcomes Among Underserved African Americans
NCT07560969 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 408
Last updated 2026-05-01
Summary
The goal of this clinical trial is to learn if an enhanced, culturally, socially, and structurally tailored Diabetes Prevention Program (E-DPP) can improve weight loss and related diabetes risk factors in African American adults with prediabetes living in low-income, socially vulnerable communities.
The main questions it aims to answer are:
* Does the enhanced DPP (E-DPP) lead to greater percent weight loss at 6 and 12 months compared to the standard culturally tailored DPP (S-DPP)?
* How do social determinants (e.g., food insecurity, stigma, access to resources) influence weight loss and engagement in lifestyle behaviors?
Researchers will compare a standard culturally tailored DPP (S-DPP) to an enhanced DPP (E-DPP) to see if improving access to healthy food, physical activity, and community resources increases weight loss and improves diabetes-related outcomes.
Participants will
1. Attend DPP sessions delivered in community settings (e.g., churches)
2. Receive lifestyle education focused on diet, physical activity, and weight loss
3. Engage in physical activity (including in-class exercise sessions \[E-DPP only\] and community-based options)
4. Receive support for healthy eating, including food deliveries (\[E-DPP only\]), food selection guidance, and referrals to food assistance programs
5. Receive information and support for accessing community resources for food and physical activity
Conditions
- Diabetes
- Physical Activity
- Food Security
- Nutrition Security
Interventions
- BEHAVIORAL
-
Culturally-tailored, enhanced adaption of Diabetes Prevention Program
This intervention adapts the CDC PreventT2 Diabetes Prevention Program into two 12-month delivery models led by community peer coaches with student support across 22 sessions (16 core, 6 maintenance). Both arms include pre-program outreach, a pre-session addressing diabetes disparities, goal setting and barrier identification, structured sessions with weigh-ins captured in REDCap, review of self-monitoring logs, and guided curriculum delivery. Participants use Wi-Fi scales and fitness trackers to support behavior change. The enhanced arm adds tailored text messaging, resource navigation, food access supports, and culturally tailored physical activity to address barriers and improve engagement and sustainability.
Sponsors & Collaborators
-
Children's Mercy Hospital Kansas City
collaborator OTHER -
University of Massachusetts, Amherst
collaborator OTHER -
San Diego State University
collaborator OTHER -
University of Kansas
collaborator OTHER -
University of Missouri, Kansas City
lead OTHER
Principal Investigators
-
Jenifer E Jenifer, PhD · University of Missouri, Kansas City
Study Design
- Allocation
- RANDOMIZED
- Purpose
- PREVENTION
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2027-01-04
- Primary Completion
- 2031-02-28
- Completion
- 2031-02-28
Countries
- United States
Study Locations
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