Addressing Social Determinants of Health to Improve Diabetes Prevention Program Outcomes Among Underserved African Americans (FIT4ALL Project)

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Phase 2
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: t
View:

• Black/African American

• Overweight (\[BMI\> 24); and

• Diagnosed with prediabetes OR pre-diagnosed with gestational diabetes OR high risk result on prediabetes risk test

Locations
United States
Missouri
University Health
NOT_YET_RECRUITING
Kansas City
University of Missouri-Kansas City
RECRUITING
Kansas City
Contact Information
Primary
Christopher Winders
windersc@umkc.edu
18162355370
Backup
Carole Bowe Thompson
bowethompsonc@umkc.edu
8162356062
Time Frame
Start Date: 2022-07-20
Estimated Completion Date: 2026-02-28
Participants
Target number of participants: 360
Treatments
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
Related Therapeutic Areas
Sponsors
Collaborators: Children's Mercy Hospital Kansas City, University Health, University of Massachusetts, Amherst, University of Kansas
Leads: University of Missouri, Kansas City

This content was sourced from clinicaltrials.gov