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NCT01636258 · ClinicalTrials.gov registry record · NA
FRESH Study (Fitness, Relaxation and Eating to Stay Healthy)
A NA study, sponsored by The Cleveland Clinic.
- Completed
- Registry status
- NA
- Development phase
- 27
- Enrollment target
NCT01636258: Completed NA study, sponsored by The Cleveland Clinic.
NCT01636258 is a NA study that has completed, run by The Cleveland Clinic. The registered enrollment target is 27 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (98% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01636258, a NA study, has completed, sponsored by The Cleveland Clinic.
- COMPLETED
- Registry status
- NA
- Development phase
- 27 participants
- Enrollment target
Study Summary
To examine whether a lifestyle program results in weight loss and thereby delays or prevents progression of pre-diabetes to diabetes, we propose a pilot randomized controlled trial of 6 weeks duration with 30 participants held at Stephanie Tubbs Jones Health Center. Participants are randomized to receive all of the following: nutrition education, exercise instruction, stress management instruction, and culinary education or follow usual care. Outcomes include: blood sugars and cholesterol, weight, waist circumference, blood pressure, diet, physical activity, perceived stress, and class attendance. Analysis is by Intention to treat analysis of variance. Results will be used to help design larger randomized trial in the future.
Primary Outcome
Change in weight measured at baseline and followup (at 8-14 weeks).
Interventions
- BEHAVIORAL Exercise
- BEHAVIORAL Stress Management
- BEHAVIORAL Diet
- BEHAVIORAL Culinary education
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 27 participants |
| Start Date | 2012-05 |
| Est. Completion | 2012-12 |
| Phase | NA |
What the finished NCT01636258 record still lists
NCT01636258 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 27 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (98% lower).
The record links to 0 conditions, and to 4 interventions - of which Exercise is the first listed.
NCT01636258 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01636258 about?
NCT01636258 is a clinical study titled "FRESH Study (Fitness, Relaxation and Eating to Stay Healthy)". To examine whether a lifestyle program results in weight loss and thereby delays or prevents progression of pre-diabetes to diabetes, we propose a pilot randomized controlled trial of 6 weeks duration with 30 participants held at Stephanie Tubbs Jones Health Center. Participants are randomized to re...
What is the current status of trial NCT01636258?
This trial is currently completed. It is a NA study. The enrollment target is 27 participants. The study started on 2012-05. Estimated completion is 2012-12.
What interventions are being tested in trial NCT01636258?
The interventions under investigation include: Exercise (BEHAVIORAL), Stress Management (BEHAVIORAL), Diet (BEHAVIORAL), Culinary education (BEHAVIORAL).
Who is sponsoring clinical trial NCT01636258?
This trial is sponsored by The Cleveland Clinic, which has 688 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01636258's enrollment target sits among peer trials
27 1708th of 2000 higher than 291 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA 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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