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NCT01713764 · ClinicalTrials.gov registry record · Phase 2
A Pilot Study of the Effects of Diet and Behavioral Interventions on Health in Diabetics
A Phase 2 study, sponsored by University of California, San Francisco.
- Completed
- Registry status
- Phase 2
- Development phase
- 34
- Enrollment target
NCT01713764: Completed Phase 2 study, sponsored by University of California, San Francisco.
NCT01713764 is a Phase 2 study that has completed, run by University of California, San Francisco. The registered enrollment target is 34 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (74% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01713764, a Phase 2 study, has completed, sponsored by University of California, San Francisco.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 34 participants
- Enrollment target
Study Summary
The study is a small pilot, designed to provide data regarding the feasibility and acceptability of conducting such a study on a larger scale. The present study is a randomized controlled clinical trial comparing two mindfulness-based lifestyle modification programs to help people manage diabetes and lose weight, one using on a low-carbohydrate diet (LC) and the other using a moderate-carbohydrate diet promoted by the American Diabetes Association (ADA). Intervention content will include information about nutrition (carbohydrate restriction or American Diabetes Association recommended diet) and emotion regulation and mindful eating strategies.
Primary Outcome
We test whether Hemoglobin A1c changes from pre-intervention to 3 months. The key outcome measure will compare the two diet groups, but we will also assess whether statistically significant changes occur within groups from pre-intervention to 3 months.
Interventions
- BEHAVIORAL Low Carbohydrate Diet
- BEHAVIORAL American Diabetes Association Diet
- BEHAVIORAL Mindfulness and Positive Affect Skills
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 34 participants |
| Start Date | 2012-10 |
| Est. Completion | 2013-11 |
| Phase | Phase 2 |
What the finished NCT01713764 record still lists
NCT01713764 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 34 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (74% lower).
The record links to 0 conditions, and to 3 interventions - of which Low Carbohydrate Diet is the first listed.
NCT01713764 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01713764 about?
NCT01713764 is a clinical study titled "A Pilot Study of the Effects of Diet and Behavioral Interventions on Health in Diabetics". The study is a small pilot, designed to provide data regarding the feasibility and acceptability of conducting such a study on a larger scale. The present study is a randomized controlled clinical trial comparing two mindfulness-based lifestyle modification programs to help people manage diabetes an...
What is the current status of trial NCT01713764?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 34 participants. The study started on 2012-10. Estimated completion is 2013-11.
What interventions are being tested in trial NCT01713764?
The interventions under investigation include: Low Carbohydrate Diet (BEHAVIORAL), American Diabetes Association Diet (BEHAVIORAL), Mindfulness and Positive Affect Skills (BEHAVIORAL).
Who is sponsoring clinical trial NCT01713764?
This trial is sponsored by University of California, San Francisco, which has 1,713 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01713764's enrollment target sits among peer trials
34 1539th of 2000 higher than 448 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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