Diabetes, Food Security, Nutrition Security, Physical Activity
Conditions
Keywords
diabetes, obesity, community-based participatory research, Weight loss, Cluster randomized trial, lifestyle change program, faith-based organizations, African American
Brief 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
Detailed description
This study is a cluster-randomized clinical trial designed to evaluate the effectiveness of an enhanced, culturally, socially, and structurally tailored Diabetes Prevention Program (E-DPP) compared to a standard culturally tailored DPP (S-DPP) among African American adults with prediabetes residing in low-income, socially vulnerable communities. The trial will enroll approximately 408 participants across 12 community-based sites (churches), which will be randomized to deliver either S-DPP or E-DPP to minimize contamination across intervention conditions. Both intervention arms are grounded in the evidence-based DPP lifestyle intervention and incorporate cultural tailoring strategies to improve relevance and acceptability in African American communities. The enhanced intervention builds upon this foundation by explicitly addressing multilevel social determinants that influence engagement in healthy eating and physical activity. Specifically, E-DPP integrates structural supports to improve access to healthy foods and safe, low-cost physical activity opportunities, alongside strategies to address social stigma related to obesity, poverty, and food insecurity. The E-DPP includes additional components delivered during and between sessions. These include provision of fruits and vegetables during sessions, experiential activities focused on healthy food selection and budgeting, and facilitated linkage to community food resources such as food pantries and assistance programs. Physical activity support includes structured in-session exercise and guidance on accessing community-based physical activity programs. Participants in the E-DPP arm will also receive tailored text messaging designed to reinforce behavior change, promote utilization of community resources, and reduce stigma-related barriers to engagement. The intervention is delivered over a 12-month period, with assessments conducted at baseline, 6 months, and 12 months. A community-engaged approach informs intervention design and implementation, ensuring alignment with local context and resources. The study is guided by theoretical frameworks that emphasize the role of social and structural determinants in shaping health behaviors and outcomes. In addition to evaluating intervention effects, the study will examine potential mediators and moderators of weight loss, including social determinant-related stressors, access to resources, and psychosocial factors. A concurrent process evaluation will assess intervention fidelity, dose, participant engagement, acceptability, and feasibility, as well as cost-related considerations. These data will inform identification of key intervention components and support future scalability and dissemination of the enhanced program in underserved communities.
Interventions
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
Study design
Intervention model description
This intervention adapts the CDC PreventT2 Diabetes Prevention Program (DPP) into two delivery models over 12 months, led by community peer coaches with student support and structured around 22 sessions (16 core, 6 maintenance). Both models emphasize engagement, self-monitoring, and culturally tailored support, with data captured via REDCap. Standard DPP (S-DPP) delivers in-person sessions following the PreventT2 curriculum. Coaches conduct outreach, lead a pre-session on disparities, goal setting, and barriers, and facilitate sessions with weigh-ins, tracking review, and curriculum delivery. Participants receive Wi-Fi scales and Fitbits. Enhanced DPP (E-DPP) integrates digital tools, resource navigation, and partnerships. Participants receive tailored text messages, track behaviors, and access resources. Coaches provide messaging support. The model includes food distributions and tailored physical activity sessions to address barriers and support behavior change.
Eligibility
Inclusion criteria
* 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)
Exclusion criteria
* 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 * Individuals who live in a household with a participant in this study at a different church
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Weight loss | Baseline, 6 months, 12 months | Percent weight loss measured as percent change in weight (in pounds) from baseline at 6 and 12 months |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Nutrition security | Baseline, 6 months, 12 months | Self-reported nutrition security |
| Dietary intake | Baseline, 6 months, 12 months | Self-reported dietary quality that assesses alignment with US dietary guidelines |
| DPP Attendance | 6 months | Number of DPP sessions attended |
| Physical activity (subjective) | Baseline, 6 months, 12 months | Self-reported physical activity |
| Physical activity (objective) | Baseline, 6 months | Physical activity measured by accelerometer |
| Use of community resources for food access | Baseline, 6 months, 12 months | Self-reported use of food access community resources |
| Use of community resources for physical activity | Baseline, 6 months, 12 months | Self-reported use of physical activity community resources |
| Blood pressure | Baseline, 6 months, 12 months | Measured systolic and diastolic blood pressure |
| Glycosylated hemoglobin | Baseline, 6 months, 12 months | Measured A1c categorized via American Diabetes Association guidelines |
| Food security | Baseline, 6 months, 12 months | Self-reported measure of household food security |
Countries
United States
Contacts
University of Missouri, Kansas City