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NCT01125397 · ClinicalTrials.gov registry record · Phase 1
Behavior Therapy Prior to Bariatric Surgery
A Phase 1 study, sponsored by Mayo Clinic.
- Completed
- Registry status
- Phase 1
- Development phase
- 34
- Enrollment target
NCT01125397: Completed Phase 1 study, sponsored by Mayo Clinic.
NCT01125397 is a Phase 1 study that has completed, run by Mayo Clinic. The registered enrollment target is 34 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01125397, a Phase 1 study, has completed, sponsored by Mayo Clinic.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 34 participants
- Enrollment target
Study Summary
Obesity is an ever increasing public health problem in this country. Bariatric surgery is currently the most effective treatment for morbid obesity and two hundred thousand surgeries are performed in the United States each year. Unfortunately, despite anatomically successful surgery, it is estimated that at most surgical centers about 30 percent of patients will not achieve significant weight loss following surgery. It has been proposed that participation in preoperative behavior therapy can enhance postoperative outcomes, although empirical evidence for this premise is lacking. The current study is a pilot project designed to conduct a prospective randomized trial to examine the impact of participation in a 12-week standardized preoperative behavioral weight management program on percentage of excess weight loss and psychosocial and medical outcomes at six months after roux-en-Y gastric bypass surgery. The cost of bariatric surgery is not covered by this study and only patients local to the Rochester, Minnesota area are eligible to participate. It is hypothesized that patients who complete the 12-week behavioral program will experience greater weight loss and improved psychosocial and medical outcomes compared to controls.
Interventions
- BEHAVIORAL LEARN group
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 34 participants |
| Start Date | 2009-11 |
| Est. Completion | 2012-10 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01125397
The ClinicalTrials.gov registry entry for NCT01125397 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 34 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Mayo Clinic, which has 2,844 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which LEARN group is the first listed.
NCT01125397 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01125397 about?
NCT01125397 is a clinical study titled "Behavior Therapy Prior to Bariatric Surgery". Obesity is an ever increasing public health problem in this country. Bariatric surgery is currently the most effective treatment for morbid obesity and two hundred thousand surgeries are performed in the United States each year. Unfortunately, despite anatomically successful surgery, it is estimated...
What is the current status of trial NCT01125397?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 34 participants. The study started on 2009-11. Estimated completion is 2012-10.
What interventions are being tested in trial NCT01125397?
The interventions under investigation include: LEARN group (BEHAVIORAL).
Who is sponsoring clinical trial NCT01125397?
This trial is sponsored by Mayo Clinic, which has 2,844 total clinical trials registered on ClinicalTrials.gov.
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