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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 is a NA study that has completed, run by The Cleveland Clinic. The registered enrollment target is 27 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01636258
The ClinicalTrials.gov registry entry for NCT01636258 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 27 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is The Cleveland Clinic, which has 688 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 4 interventions - of which Exercise is the first listed.
NCT01636258 reports 0 study locations.
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.
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