Addressing Food Access and Physical Activity to Improve Diabetes Prevention Outcomes Among Underserved African Americans

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Missouri, Kansas City

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Members of a participating church or user of a participating church's outreach services

Age 18 years or older

Prediabetic (score of 5 or higher in the National Diabetes Prevention Program Risk Score or ([body mass index > 24 or history of gestational diabetes] and (5.7-6.4 A1v, 100-125 mg/dL fasting plasma glucose, or 140-149 mg/dL oral glucose tolerance test)

Disqualifiers

Individuals who are pregnant, breastfeeding or planning to become pregnant in the next year

Individuals with unsafe blood pressure levels (160 systolic or higher or 100 diastolic or higher) without a medical clearance firn

Individuals who are not able to engage in low-impact physical activity

Individuals who do not speak English

Trial design

Design model

Parallel

Treatments tested in this trial

  • Culturally-tailored, enhanced adaption of Diabetes Prevention Program

    Behavioral

    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.

Treatment groups

408 Participants
are divided into 2 treatment groups
Group A: Standard Diabetes Prevention Program (S-DPP)Active comparator 1 intervention
Group B: Enhanced Diabetes Prevention Program (E-DPP)Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Weight loss

Percent weight loss measured as percent change in weight (in pounds) from baseline at 6 and 12 months

Time frame
Baseline, 6 months, 12 months

Secondary outcomes

1

Nutrition security

Self-reported nutrition security

Time frame
Baseline, 6 months, 12 months
2

Dietary intake

Self-reported dietary quality that assesses alignment with US dietary guidelines

Time frame
Baseline, 6 months, 12 months
3

DPP Attendance

Number of DPP sessions attended

Time frame
6 months
4

Physical activity (subjective)

Self-reported physical activity

Time frame
Baseline, 6 months, 12 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Missouri, Kansas City

Lead sponsor

Children's Mercy Hospital Kansas City

Collaborator

University of Massachusetts, Amherst

Collaborator

San Diego State University

Collaborator

University of Kansas

Collaborator

This trial is not recruiting at the moment. You can still explore other options: