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NCT00666952 · ClinicalTrials.gov registry record · NA
Study Testing Patient Decision Tools Related to the Risks and Benefits of Weight Loss Surgery
A NA study, sponsored by Kaiser Permanente.
- Completed
- Registry status
- NA
- Development phase
- 150
- Enrollment target
NCT00666952 is a NA study that has completed, run by Kaiser Permanente. The registered enrollment target is 150 participants.
The verdict
NCT00666952, a NA study, has completed, sponsored by Kaiser Permanente.
- COMPLETED
- Registry status
- NA
- Development phase
- 150 participants
- Enrollment target
Study Summary
Morbid obesity currently affects more than 11 million US adults and is strongly associated with type 2 diabetes, cancer, cardiovascular disease, and arthritis. Bariatric (weight loss) surgical procedures have been shown to significantly reduce body weight and improve the health and quality of life of morbidly obese adults, at least in the short term. However, bariatric surgery also presents substantial risks, including a 10% to 20% risk of serious complications and up to a 2% risk of death in the first 30 days after surgery. Thus, a morbidly obese patient's decision regarding bariatric surgery should be based on his or her evaluation of accurate information on the possible risks and benefits of the various treatment options. Anecdotal reports suggest that bariatric treatment decisions may be more heavily influenced by insurance coverage and reimbursement rates than patient preferences. The main objective of the current proposal is to examine the impact of a bariatric decision aid, Weight loss surgery: Is it right for you?, on decision quality in primary care and bariatric specialty practice settings. We propose a randomized controlled trial to assess the effect of this bariatric decision aid on bariatric-specific measures of patient knowledge, values and choice of weight management strategy. We will also investigate the effect of the decision aid on decisional conflict and decisional self-efficacy and examine medical, psychological, and behavioral factors as mediators and moderators of treatment choice. This information will help to elucidate the value of this decision aid in improving decision quality. The primary aims of this of this research are to: 1. Determine if the bariatric decision aid results in superior bariatric surgery decision quality than an NIH booklet on weight loss surgery ('usual care'). 2. Determine if the bariatric decision aid results in less decisional conflict and superior decisional self-efficacy than usual care. 3. Determine if there is
Interventions
- OTHER Video Decision Aid
- OTHER Booklet Decision Aid
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 150 participants |
| Start Date | 2008-05 |
| Est. Completion | 2009-01 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00666952
The ClinicalTrials.gov registry entry for NCT00666952 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 150 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Kaiser Permanente, which has 294 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Video Decision Aid is the first listed.
NCT00666952 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00666952 about?
NCT00666952 is a clinical study titled "Study Testing Patient Decision Tools Related to the Risks and Benefits of Weight Loss Surgery". Morbid obesity currently affects more than 11 million US adults and is strongly associated with type 2 diabetes, cancer, cardiovascular disease, and arthritis. Bariatric (weight loss) surgical procedures have been shown to significantly reduce body weight and improve the health and quality of life o...
What is the current status of trial NCT00666952?
This trial is currently completed. It is a NA study. The enrollment target is 150 participants. The study started on 2008-05. Estimated completion is 2009-01.
What interventions are being tested in trial NCT00666952?
The interventions under investigation include: Video Decision Aid (OTHER), Booklet Decision Aid (OTHER).
Who is sponsoring clinical trial NCT00666952?
This trial is sponsored by Kaiser Permanente, which has 294 total clinical trials registered on ClinicalTrials.gov.
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