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NCT05301413 · ClinicalTrials.gov registry record · Phase 2
Social Determinants and a Diabetes Prevention Program Tailored for African Americans
A Phase 2 study of Overweight and Obesity and PreDiabetes, sponsored by University of Missouri, Kansas City.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 360
- Enrollment target
- 2
- Study locations
NCT05301413 is a Phase 2 study of Overweight and Obesity and PreDiabetes that is actively recruiting participants, run by University of Missouri, Kansas City. The registered enrollment target is 360 participants, above the 225-participant average among 115 other Overweight and Obesity trials with a reported enrollment target (60% higher). The trial reports 2 study locations across 1 state.
The verdict
NCT05301413, a Phase 2 study of Overweight and Obesity and PreDiabetes, is actively recruiting participants, sponsored by University of Missouri, Kansas City.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 360 participants
- Enrollment target
- 2
- Study locations
Study 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.
Conditions Studied
Interventions
- BEHAVIORAL Culturally Tailored Diabetes Prevention Program
- BEHAVIORAL Culturally Tailored DPP Enhanced with Socioeconomic Supports
- BEHAVIORAL Diabetes Prevention Program
Study Locations (2)
Missouri
- University Health - Kansas City
- University of Missouri-Kansas City - Kansas City
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 360 participants |
| Start Date | 2022-07-20 |
| Est. Completion | 2026-02-28 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05301413
The ClinicalTrials.gov registry entry for NCT05301413 describes a study currently listed as recruiting, categorized as Phase 2. The registered enrollment target is 360 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 225-participant average among 115 other Overweight and Obesity trials with a reported enrollment target (60% higher). The listed sponsor is University of Missouri, Kansas City, which has 33 total studies on file at ClinicalTrials.gov.
The record links to 2 conditions, with Overweight and Obesity appearing as the primary indexed condition, and to 3 interventions - of which Culturally Tailored Diabetes Prevention Program is the first listed.
NCT05301413 reports 2 study locations spanning 1 distinct geographic area - top geographies include Missouri.
Frequently Asked Questions
What is clinical trial NCT05301413 about?
NCT05301413 is a clinical study titled "Social Determinants and a Diabetes Prevention Program Tailored for African Americans". 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 si...
What is the current status of trial NCT05301413?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 360 participants. The study started on 2022-07-20. Estimated completion is 2026-02-28.
What conditions does trial NCT05301413 study?
This clinical trial studies the following conditions: Overweight and Obesity, PreDiabetes.
What interventions are being tested in trial NCT05301413?
The interventions under investigation include: Culturally Tailored Diabetes Prevention Program (BEHAVIORAL), Culturally Tailored DPP Enhanced with Socioeconomic Supports (BEHAVIORAL), Diabetes Prevention Program (BEHAVIORAL).
Who is sponsoring clinical trial NCT05301413?
This trial is sponsored by University of Missouri, Kansas City, which has 33 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05301413 being conducted?
This trial has 2 study locations across Missouri. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Related
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