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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 PreDiabetes and Overweight and Obesity, sponsored by University of Missouri, Kansas City.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 360
- Enrollment target
- 2
- Study locations
NCT05301413: Recruiting Phase 2 study of PreDiabetes and Overweight and Obesity, sponsored by University of Missouri, Kansas City.
NCT05301413 is a Phase 2 study of PreDiabetes and Overweight and Obesity that is actively recruiting participants, run by University of Missouri, Kansas City. The registered enrollment target is 360 participants, below the 699-participant average among 149 other PreDiabetes trials with a reported enrollment target (48% lower). The trial reports 2 study locations across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05301413, a Phase 2 study of PreDiabetes and Overweight and Obesity, 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.
Primary Outcome
Percentage of weight loss from initial baseline weight
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 |
What NCT05301413 shows while recruiting
NCT05301413 is an interventional study that assigns participants to a tested intervention. The registered 360 participants enrollment target is mid-sized for trials with a published cap, below the 699-participant average among 149 other PreDiabetes trials with a reported enrollment target (48% lower).
The record links to 2 conditions, with PreDiabetes appearing as the primary indexed condition, and to 3 interventions - of which Culturally Tailored Diabetes Prevention Program is the first listed.
NCT05301413 reports a single indexed study location in 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: PreDiabetes, Overweight and Obesity.
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.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT05301413's enrollment target sits among peer trials
360 22nd of 149 higher than 128 of 149 other PreDiabetes trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other PreDiabetes trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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