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NCT01227473 · ClinicalTrials.gov registry record · Phase 1
We Can Prevent Diabetes: A Behavioral Intervention to Reduce Diabetes Risk in African Americans
A Phase 1 study, sponsored by University of North Carolina, Chapel Hill.
- Completed
- Registry status
- Phase 1
- Development phase
- 74
- Enrollment target
NCT01227473: Completed Phase 1 study, sponsored by University of North Carolina, Chapel Hill.
NCT01227473 is a Phase 1 study that has completed, run by University of North Carolina, Chapel Hill. The registered enrollment target is 74 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (23% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01227473, a Phase 1 study, has completed, sponsored by University of North Carolina, Chapel Hill.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 74 participants
- Enrollment target
Study Summary
Pre-diabetes, characterized by glucose levels that are above normal but below the diagnostic criteria for diabetes, is an increasingly common condition, particularly among African Americans. Changes in physical activity, changes in diet, and levels of stress influence the course of the disease. Helping individuals to reduce stress and to increase healthy coping strategies may enhance conventional diabetes prevention efforts, especially among African Americans. Mindfulness training is a cost-effective intervention which may be effective in reducing stress and enhancing the ability to make behavioral changes. This exploratory pilot study will examine the potential efficacy of a diabetes prevention education program that includes training in mindfulness-based stress reduction (intervention group) for pre-diabetic African Americans, comparing it to a conventional diabetes prevention program (control group) in the ability to improve glucose metabolism as well as other relevant physiological and psychological secondary outcomes.
Primary Outcome
The homeostatic model assessment-insulin resistance (HOMA-IR) is a calculated measure based on the FPG and fasting insulin levels.
Interventions
- BEHAVIORAL Mindfulness-based diabetes prevention education group
- BEHAVIORAL Conventional diabetes prevention education group
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 74 participants |
| Start Date | 2010-02 |
| Est. Completion | 2012-05 |
| Phase | Phase 1 |
What the finished NCT01227473 record still lists
NCT01227473 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 74 participants, a relatively small participant target, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (23% higher).
The record links to 0 conditions, and to 2 interventions - of which Mindfulness-based diabetes prevention education group is the first listed.
NCT01227473 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01227473 about?
NCT01227473 is a clinical study titled "We Can Prevent Diabetes: A Behavioral Intervention to Reduce Diabetes Risk in African Americans". Pre-diabetes, characterized by glucose levels that are above normal but below the diagnostic criteria for diabetes, is an increasingly common condition, particularly among African Americans. Changes in physical activity, changes in diet, and levels of stress influence the course of the disease. Help...
What is the current status of trial NCT01227473?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 74 participants. The study started on 2010-02. Estimated completion is 2012-05.
What interventions are being tested in trial NCT01227473?
The interventions under investigation include: Mindfulness-based diabetes prevention education group (BEHAVIORAL), Conventional diabetes prevention education group (BEHAVIORAL).
Who is sponsoring clinical trial NCT01227473?
This trial is sponsored by University of North Carolina, Chapel Hill, which has 1,109 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01227473's enrollment target sits among peer trials
74 725th of 2000 higher than 1,269 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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.
Source ClinicalTrials.gov registry export · 2026-08-08
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