NCT05301413 Social Determinants and a Diabetes Prevention Program Tailored for African Americans
| NCT ID | NCT05301413 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | University of Missouri, Kansas City |
| Condition | PreDiabetes |
| Study Type | INTERVENTIONAL |
| Enrollment | 360 participants |
| Start Date | 2022-07-20 |
| Primary Completion | 2025-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 360 participants in total. It began in 2022-07-20 with a primary completion date of 2025-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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
Contact & Investigator
Jannette Y Berkley-Patton, PhD
PRINCIPAL INVESTIGATOR
University of Missouri-Columbia
Frequently Asked Questions
Who can join the NCT05301413 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying PreDiabetes. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05301413 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT05301413 currently recruiting?
Yes, NCT05301413 is actively recruiting participants. Contact the research team at windersc@umkc.edu for enrollment information.
Where is the NCT05301413 trial being conducted?
This trial is being conducted at Kansas City, United States, Kansas City, United States.
Who is sponsoring the NCT05301413 clinical trial?
NCT05301413 is sponsored by University of Missouri, Kansas City. The principal investigator is Jannette Y Berkley-Patton, PhD at University of Missouri-Columbia. The trial plans to enroll 360 participants.
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