Clinical Trial

Social Determinants and a Diabetes Prevention Program Tailored for African Americans

Study acronym: FIT4ALL
Recruiting Phase 2
View on ClinicalTrials.gov →
Record status
This record was last updated May 25, 2025 (before its estimated December 31, 2025 completion). Its status may not reflect the trial's current state.
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.
Protocol Amendment History 4 amendments
This ClinicalTrials.gov record has been amended 4 times since 2022-03-28; most recent amendment 2025-05-20.
Status change: Not Yet Recruiting → Recruiting 2023-03-21
Trial Details
NCT Number NCT05301413
Lead Sponsor University of Missouri, Kansas City
Collaborators: University of Massachusetts, Amherst, University of Kansas, Children's Mercy Hospital Kansas City, University Health
Conditions PreDiabetes, Overweight and Obesity
Enrollment 360 participants
Start Date 2022-07-20
Primary Completion 2025-12-31 (estimated)
Study Completion 2026-02-28 (estimated)
Updated on ClinicalTrials.gov 2025-05-25