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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 is a Phase 1 study that has completed, run by University of North Carolina, Chapel Hill. The registered enrollment target is 74 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01227473
The ClinicalTrials.gov registry entry for NCT01227473 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 74 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of North Carolina, Chapel Hill, which has 1,109 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Mindfulness-based diabetes prevention education group is the first listed.
NCT01227473 reports 0 study locations.
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.
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