NCT07560969

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
  • Attend DPP sessions delivered in community settings (e.g., churches)
  • Receive lifestyle education focused on diet, physical activity, and weight loss
  • Engage in physical activity (including in-class exercise sessions \[E-DPP only\] and community-based options)
  • Receive support for healthy eating, including food deliveries (\[E-DPP only\]), food selection guidance, and referrals to food assistance programs
  • Receive information and support for accessing community resources for food and physical activity

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
408

participants targeted

Target at P75+ for not_applicable diabetes

Timeline
51mo left

Started Jan 2027

Longer than P75 for not_applicable diabetes

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 24, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

May 1, 2026

Completed
8 months until next milestone

Study Start

First participant enrolled

January 4, 2027

Expected
4.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2031

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2031

Last Updated

May 1, 2026

Status Verified

April 1, 2026

Enrollment Period

4.2 years

First QC Date

April 24, 2026

Last Update Submit

April 24, 2026

Conditions

Food SecurityDiabetesPhysical ActivityNutrition Security

Keywords

diabetesobesitycommunity-based participatory researchWeight lossCluster randomized triallifestyle change programfaith-based organizationsAfrican American

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (10)

  • Nutrition security

    Baseline, 6 months, 12 months

  • Dietary intake

    Baseline, 6 months, 12 months

  • DPP Attendance

    6 months

  • Physical activity (subjective)

    Baseline, 6 months, 12 months

  • Physical activity (objective)

    Baseline, 6 months

  • +5 more secondary outcomes

Study Arms (2)

Standard Diabetes Prevention Program (S-DPP)

ACTIVE COMPARATOR

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

Enhanced Diabetes Prevention Program (E-DPP)

EXPERIMENTAL

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

Interventions

Culturally-tailored, enhanced adaption of Diabetes Prevention ProgramBEHAVIORAL

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.

Enhanced Diabetes Prevention Program (E-DPP)Standard Diabetes Prevention Program (S-DPP)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Missouri-Kansas City

Kansas City, Missouri, 64108, United States

Location

MeSH Terms

Conditions

Diabetes MellitusMotor ActivityObesityWeight Loss

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesBehaviorOverweightOvernutritionNutrition DisordersBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsBody Weight Changes

Study Officials

  • Jenifer E Jenifer, PhD

    University of Missouri, Kansas City

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Jenifer E Allsworth, PhD

CONTACT

816-235-1781allsworthj@umkc.edu

Jannette E Berkley-Patton, PhD

CONTACT

816-235-1781berkleypattonj@umkc.edu

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

April 24, 2026

First Posted

May 1, 2026

Study Start (Estimated)

January 4, 2027

Primary Completion (Estimated)

February 28, 2031

Study Completion (Estimated)

February 28, 2031

Last Updated

May 1, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will share

De-identified study data for participants will be shared in an NIH-approved repository or made available by request from the PIs.

Time Frame
Data will be shared within 12 months of study completion.
Access Criteria
De-identified data will be available to researchers who sign a data use agreement.

Locations

US(1)