Diabetes prevention program tailored for African Americans
Addressing Social Determinants of Health to Improve Diabetes Prevention Program Outcomes Among Underserved African Americans (FIT4ALL Project)
This study is testing a diabetes prevention program designed specifically for African Americans to see if a culturally tailored approach helps them lose weight and attend the program better.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 360 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Missouri, Kansas City Academic / other |
| Locations | 2 sites (Kansas City, Missouri and 1 other locations) |
| Trial ID | NCT05301413 on ClinicalTrials.gov |
What this trial studies
This study aims to improve attendance and weight loss outcomes in a Diabetes Prevention Program (DPP) specifically designed for African Americans, who face higher rates of diabetes and obesity. Participants will be randomized into three groups: a standard DPP, a culturally-tailored DPP, and a culturally-tailored DPP enhanced with socioeconomic support. The study addresses social determinants of health that impact attendance and outcomes, focusing on the unique challenges faced by low-income African Americans. By tailoring the program to cultural and socioeconomic needs, the study seeks to enhance the effectiveness of diabetes prevention efforts in this underserved population.
Who should consider this trial
Good fit: Ideal candidates for this study are Black/African American individuals who are overweight and diagnosed with prediabetes or at high risk for diabetes.
Not a fit: Patients who are already diagnosed with diabetes or have medical conditions that prevent participation in the program may not benefit from this study.
Why it matters
Potential benefit: If successful, this program could significantly reduce the incidence of Type 2 diabetes among African Americans by improving attendance and weight loss outcomes.
How similar studies have performed: Previous studies have shown that culturally tailored interventions can improve health outcomes in minority populations, suggesting potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Kansas City, Missouri and 1 other locations
- University Health — Kansas City, Missouri, United States (Not_yet_recruiting)
- University of Missouri-Kansas City — Kansas City, Missouri, United States (Recruiting)
Study contacts
- Principal investigator: Jannette Y Berkley-Patton, PhD — University of Missouri-Columbia
- Study coordinator: Christopher Winders
- Email: windersc@umkc.edu
- Phone: 18162355370
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.