Social Determinants and a Diabetes Prevention Program Tailored for African Americans

Part of paid clinical trials in Kansas City, Missouri.

Sponsor
University of Missouri, Kansas City
Study ID
NCT05301413
Phase
PHASE2
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Accepted

Interventions

  • Culturally Tailored Diabetes Prevention Program — BEHAVIORAL
    This intervention includes a culturally tailored DPP curriculum, class procedures, and handouts
  • Culturally Tailored DPP Enhanced with Socioeconomic Supports — BEHAVIORAL
    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 — BEHAVIORAL
    This is the CDC TD2 evidence-based Diabetes Prevention Program

Study Details

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.

Key Dates

Start date
Jul 20, 2022
Status verified
May 2025
Primary completion
Dec 31, 2025
Completion
Feb 28, 2026

Study Design

Enrollment
360 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

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

Primary Outcome Measure

Percent Weight Loss [ Time Frame: 6 months ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
University HealthKansas CityMissouri64108
Betty Drees, M.D.
[email protected]
816-404-4070
Betty Drees (SUB_INVESTIGATOR)
University of Missouri-Kansas CityKansas CityMissouri64108
Jannette Berkley-Patton, PhD
816-235-6362

Find similar trials in Kansas City, MO

By condition
Obesity / overweight
By specialty
EndocrinologyMetabolic healthWeight loss
By research site
University Health· Kansas City, MOUniversity of Missouri-Kansas City· Kansas City, MO

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