NCT05301413RecruitingPhase 2
Social Determinants and a Diabetes Prevention Program Tailored for African Americans
Addressing Social Determinants of Health to Improve Diabetes Prevention Program Outcomes Among Underserved African Americans (FIT4ALL Project)
Source: ClinicalTrials.gov · Last updated 25 May 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 360 (estimated)
- First submitted
- 9 Mar 2022
- Start date
- 20 Jul 2022
- Primary completion date
- 31 Dec 2025
- Lead sponsor
- University of Missouri, Kansas City
- Diseases
- Obesity
- NCT number
- NCT05301413
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 360
- From 20 Jul 2022 to the primary completion date, 31 Dec 2025
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Bariatric weight loss surgery in last year
Other illness
- Diagnosed with diabetes
- Currently have a medical condition that causes drastic weight loss
- Had heart failure
Other
- 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
- Cannot walk a 1-block distance without assistance and without stopping due to pain, tightness, or pressure in the chest
- 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
Who the study is looking for
- Black/African American
- Overweight (\[BMI\> 24); and
- Diagnosed with prediabetes OR pre-diagnosed with gestational diabetes OR high risk result on prediabetes risk test
Age in the registry: 18 years to - · Sex: All · Accepts healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University Health Coordinator of this site? Confirm its status | Kansas City | United States | Not yet recruiting |
| University of Missouri-Kansas City Coordinator of this site? Confirm its status | Kansas City | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.