A Phase 2 interventional study of Decider Guider: Weight Loss in Morbid Obesity and Weight Reduction, sponsored by University of Michigan. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-09-26.
Sponsored by University of Michigan · Phase 2, Interventional, and Other
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.
Our specific aims are:
This research is closely aligned with the goals of PCORI and will have direct impacts on patients and caregivers by providing information that is required to improve healthcare decision-making for this prevalent, damaging, and costly condition.
922 studies on the registry are indexed under Obesity, Morbid; 172 are open to participants now.
This study's planned enrollment of 1,000 is above the median of 60 across 590 interventional studies indexed under Obesity, Morbid.
Browse Obesity, Morbid studies →University of Michigan is the lead sponsor of 1,475 studies on the registry; 196 are open to participants now.
Of its 162 completed or terminated interventional studies of FDA-regulated products, 128 (79%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Potential bariatric surgery patients who receive both the baseline questionnaire and follow-up questionnaire.
Potential bariatric surgery patients who receive both the baseline questionnaire decision aid/conjoint analysis and follow-up questionnaire.
Behavioral: Decider Guider: Weight Loss
Decision aid tool about weight loss treatment
Decision outcome by Decider Guider Questionnaire
Decisional measures
Time frame: 24 months
Patient specific outcome by Decider Guider Questionnaire
Time frame: 24 months
Knowledge, as measured by a follow-up Decider Guider questionnaire to test knowledge
Time frame: 24 months
Preferences as measured by Decider Guider Questionnaire
Time frame: 24 months
Weight
Time frame: 24 months
Quality of Life as measured by Decider Guider Questionnaire
Time frame: 24 months
Comorbidity Resolution as measured by Decider Guider Questionnaire
Time frame: 24 months
Patient Satisfaction as measured by Decider Guider Questionnaire
Time frame: 24 months
This study is completed, as verified in Sep 2018. You cannot join it, but the record below documents what was studied.
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University of Michigan