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

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

Study Overview

• Status: Not yet recruiting
• Conditions: Diabetes; Physical Activity; Food Security; Nutrition Security
• Intervention / Treatment: Behavioral: Culturally-tailored, enhanced adaption of Diabetes Prevention Program

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.

• Study Type: Interventional
• Enrollment (Estimated): 408
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jenifer E Allsworth, PhD; Phone Number: 816-235-1781; Email: allsworthj@umkc.edu
• Study Contact Backup: Name: Jannette E Berkley-Patton, PhD; Phone Number: 816-235-1781; Email: berkleypattonj@umkc.edu

Study Locations

• United States
  • Missouri
    • Kansas City, Missouri, United States, 64108
      • University of Missouri-Kansas City
      • Contact: Jenifer E Allsworth, PhD; Phone Number: 816-235-1781; Email: allsworthj@umkc.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Standard Diabetes Prevention Program (S-DPP); Standard DPP (S-DPP) is a 12-month, in-person lifestyle intervention based on the CDC PreventT2 curriculum, delivered by community peer coaches across 22 sessions (16 core, 6 maintenance). Coaches conduct pre-program outreach and a pre-session addressing diabetes disparities, goal setting, and attendance barriers. Each session includes weigh-ins with REDCap capture, review of self-monitoring logs for diet, activity, and goals, and guided delivery of the curriculum. Participants receive Wi-Fi scales and fitness trackers to support weight loss and physical activity tracking. Certain sessions provide information on local, low- or no-cost food and physical activity resources to support and maintain behavior change.	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.
Experimental: Enhanced Diabetes Prevention Program (E-DPP); Enhanced DPP (E-DPP) is a 12-month intervention based on the CDC PreventT2 curriculum that integrates digital tools, community resources, and culturally tailored supports across 22 sessions (16 core, 6 maintenance). Coaches conduct pre-program outreach and a pre-session addressing diabetes disparities, goal setting, and attendance barriers. Sessions include weigh-ins with REDCap capture, review of self-monitoring logs, and guided curriculum delivery. Participants receive Wi-Fi scales and fitness trackers and access tailored text messages with DPP content and resource links. Coaches provide additional messaging support. The model also includes in-class healthy food distribution and culturally tailored physical activity sessions, as well as information on local low- or no-cost resources to support sustained behavior change.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Weight loss	Percent weight loss measured as percent change in weight (in pounds) from baseline at 6 and 12 months	Baseline, 6 months, 12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Nutrition security	Self-reported nutrition security	Baseline, 6 months, 12 months
Dietary intake	Self-reported dietary quality that assesses alignment with US dietary guidelines	Baseline, 6 months, 12 months
DPP Attendance	Number of DPP sessions attended	6 months
Physical activity (subjective)	Self-reported physical activity	Baseline, 6 months, 12 months
Physical activity (objective)	Physical activity measured by accelerometer	Baseline, 6 months
Use of community resources for food access	Self-reported use of food access community resources	Baseline, 6 months, 12 months
Use of community resources for physical activity	Self-reported use of physical activity community resources	Baseline, 6 months, 12 months
Blood pressure	Measured systolic and diastolic blood pressure	Baseline, 6 months, 12 months
Glycosylated hemoglobin	Measured A1c categorized via American Diabetes Association guidelines	Baseline, 6 months, 12 months
Food security	Self-reported measure of household food security	Baseline, 6 months, 12 months

Collaborators and Investigators

• Sponsor: University of Missouri, Kansas City
• Collaborators: San Diego State University; Children's Mercy Hospital Kansas City; University of Massachusetts, Amherst; University of Kansas
• Investigators: Principal Investigator: Jenifer E Jenifer, PhD, University of Missouri, Kansas City

Study record dates

Study Major Dates

• Study Start (Estimated): January 4, 2027
• Primary Completion (Estimated): February 28, 2031
• Study Completion (Estimated): February 28, 2031

Study Registration Dates

• First Submitted: April 24, 2026
• First Submitted That Met QC Criteria: April 24, 2026
• First Posted (Actual): May 1, 2026

Study Record Updates

• Last Update Posted (Actual): May 1, 2026
• Last Update Submitted That Met QC Criteria: April 24, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: diabetes; Cluster randomized trial; obesity; Weight loss; African American; community-based participatory research; faith-based organizations; lifestyle change program
• Additional Relevant MeSH Terms: Endocrine System Diseases; Nutrition Disorders; Metabolic Diseases; Overnutrition; Body Weight; Body Weight Changes; Glucose Metabolism Disorders; Overweight; Pathological Conditions, Signs and Symptoms; Behavior; Nutritional and Metabolic Diseases; Signs and Symptoms; Obesity; Weight Loss; Diabetes Mellitus; Motor Activity
• Other Study ID Numbers: 2130354

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: De-identified study data for participants will be shared in an NIH-approved repository or made available by request from the PIs.
• IPD Sharing Time Frame: Data will be shared within 12 months of study completion.
• IPD Sharing Access Criteria: De-identified data will be available to researchers who sign a data use agreement.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No