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 volunteersQualifiers
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
Parallel
Treatments tested in this trial
Culturally-tailored, enhanced adaption of Diabetes Prevention Program
BehavioralThis 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
Trial outcomes
Primary outcomes
Weight loss
Percent weight loss measured as percent change in weight (in pounds) from baseline at 6 and 12 months
Secondary outcomes
Nutrition security
Self-reported nutrition security
Dietary intake
Self-reported dietary quality that assesses alignment with US dietary guidelines
DPP Attendance
Number of DPP sessions attended
Physical activity (subjective)
Self-reported physical activity
Sponsors and contacts
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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: