Recruiting
Phase 2

Diabetes Prevention

Sponsor:

University of Missouri, Kansas City

Code:

NCT05301413

Conditions

PreDiabetes

Overweight and Obesity

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Interventions

Culturally Tailored Diabetes Prevention Program

Culturally Tailored DPP Enhanced with Socioeconomic Supports

Diabetes Prevention Program

Study Details

Brief summary:

African Americans (AAs) have rates of diabetes mellitus (DM) twice that of Whites and are disproportionately affected by leading risk factors for DM - obesity and low-income. A critical strategy in the battle against DM is the Diabetes Prevention Program (DPP), an evidence-based intervention that significantly delays or prevents Type 2 diabetes through the promotion of diet change, exercise and modest weight loss. However, weight loss from the DPP among AAs is about half that of White participants, and suboptimal AA attendance is a critical contributor. The investigators propose to conduct a study that will address social determinants (SD) that challenge DPP attendance with underserved African Americans from a safety net hospital. The investigators will examine DPP attendance and weight loss with participants randomized to 3 groups: standard DPP, a culturally-tailored DPP to address acceptability, and a culturally-tailored DPP enhanced to address socioeconomic-related barriers to DPP participation. This novel study is the first to tailor the DPP to address SD cultural and socioeconomic barriers that limit DPP attendance and reduce its effectiveness on outcomes. The proposed multidimensional, SD tailored DPP has great potential to be a feasible and scalable model to reduce DM risks among urban, African Americans and ultimately reduce DM disparities.

Conditions

PreDiabetes

Overweight and Obesity

Study ID

NCT05301413

Start date

Jul 20, 2022

Status verified date

May, 2025

Completion date

Feb 28, 2026

Anticipated

Primary completion date

Dec 31, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Inclusion Criteria:

  • Black/African American
  • Overweight (\[BMI> 24); and
  • Diagnosed with prediabetes OR pre-diagnosed with gestational diabetes OR high risk result on prediabetes risk test

Exclusion Criteria:

  • Diagnosed with diabetes
  • Pregnant
  • Not fluent in English
  • Currently pregnant, planning a pregnancy in the next year, currently breastfeeding or have given birth in the last 6 months
  • Currently participating in a weight loss program
  • Currently have a medical condition that causes drastic weight loss
  • Bariatric weight loss surgery in last year
  • Cannot walk a 1-block distance without assistance and without stopping due to pain, tightness, or pressure in the chest
  • Had heart failure
  • Not willing to use a fitness tracker, wi-fi scale, and the internet
  • Not available in the evening one day each week to participate in a class

Study Design

Enrollment

360 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

active comparator: Standard

Standard Diabetes Prevention Program (DPP)

experimental: Culturally Tailored DPP

DPP culturally tailored for African Americans

experimental: Culturally Tailored DPP Enhanced with Socioeconomic Supports

Culturally tailored DPP plus promotions for class attendance, hybrid attendance (in-person and virtual), and linkage to care services provided by a community health worker

Interventions

Culturally Tailored Diabetes Prevention Program

This intervention includes a culturally tailored DPP curriculum, class procedures, and handouts

Culturally Tailored DPP Enhanced with Socioeconomic Supports

This intervention includes the culturally tailored DPP curriculum, class procedures, and handouts along with promotional items for class participation, opportunities to attend class in-person or virtually through a digital platform, and assistance from a community health worker to provide linkage to health care services and community resources

Diabetes Prevention Program

This is the CDC TD2 evidence-based Diabetes Prevention Program

Primary outcome measure

  • Percent Weight Loss [ Time Frame: 6 months ]
  • Percent Weight Loss [ Time Frame: 12 months ]
  • DPP Class Attendance [ Time Frame: 6 months ]
  • DPP Class Attendance [ Time Frame: 12 months ]

Central Contacts and Locations

Central contacts

Locations

University of Missouri-Kansas City

Recruiting

Kansas City, Missouri, United States, 64108

Contacts

Jannette Berkley-Patton, PhD

816-235-6362

More Information

Sponsor

University of Missouri, Kansas City

Last update posted

May 25, 2025

Last verified

May, 2025

Keywords

  • African American
  • Prediabetes
  • Diabetes Prevention Program
  • Cultural tailoring
  • Linkage to care
  • Weight loss
  • Class attendance

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by University of Missouri, Kansas City on 2025-05-25.