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NCT02364128 · ClinicalTrials.gov registry record · Phase 2
Improving Patient Decisions About Bariatric Surgery
A Phase 2 study, sponsored by University of Michigan.
- Completed
- Registry status
- Phase 2
- Development phase
- 1,000
- Enrollment target
NCT02364128 is a Phase 2 study that has completed, run by University of Michigan. The registered enrollment target is 1,000 participants.
The verdict
NCT02364128, a Phase 2 study, has completed, sponsored by University of Michigan.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 1,000 participants
- Enrollment target
Study Summary
At least 15 million Americans are morbidly obese, or more than 100 pounds overweight. Medical treatments including drugs and behavior modification have proven ineffective in producing significant and lasting weight loss in this group. While bariatric surgery is extremely effective for most patients, it also carries risks for both short and long-term complications. There are currently four different types of bariatric surgery available and the risks and benefits of these procedures vary widely and are strongly affected by patient and clinical characteristics. Decision making under these circumstances should reflect informed patient's values and preferences regarding these trade-offs. Instead, the choice of bariatric procedure is more often driven by the beliefs and experiences of the bariatric surgeon that a patient happens to see. Variability in the type of surgery recommended to patients likely results from some combination of surgeons' subjective opinions and personal experiences with regard to the risks and benefits of the treatment options and delegated decision making on the part of patients. The goals of this research proposal are to develop, implement, and evaluate an informed decision support tool for treatment of morbid obesity. This project will be conducted within the context of the Michigan Bariatric Surgery Collaborative (MBSC), which is a statewide clinical registry and quality improvement program that has the participation of virtually every bariatric surgeon and program in the state of Michigan. The MBSC registry now includes externally audited clinical data for more than 80,000 consecutive bariatric surgery patients. MBSC outcome measures include complications occurring within 30 days as well as weight loss, comorbidity resolution, quality of life and satisfaction at 1, 2, and 3 years after bariatric surgery.
Interventions
- BEHAVIORAL Decider Guider: Weight Loss
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,000 participants |
| Start Date | 2014-01-01 |
| Est. Completion | 2018-09-15 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02364128
The ClinicalTrials.gov registry entry for NCT02364128 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 1,000 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Michigan, which has 1,327 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Decider Guider: Weight Loss is the first listed.
NCT02364128 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02364128 about?
NCT02364128 is a clinical study titled "Improving Patient Decisions About Bariatric Surgery". At least 15 million Americans are morbidly obese, or more than 100 pounds overweight. Medical treatments including drugs and behavior modification have proven ineffective in producing significant and lasting weight loss in this group. While bariatric surgery is extremely effective for most patients,...
What is the current status of trial NCT02364128?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 1,000 participants. The study started on 2014-01-01. Estimated completion is 2018-09-15.
What interventions are being tested in trial NCT02364128?
The interventions under investigation include: Decider Guider: Weight Loss (BEHAVIORAL).
Who is sponsoring clinical trial NCT02364128?
This trial is sponsored by University of Michigan, which has 1,327 total clinical trials registered on ClinicalTrials.gov.
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