The Potential Effectiveness of Behavior Therapy on Weight Loss Following Bariatric Surgery
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- Mayo Clinic
- Enrollment
- 34
- Locations
- 2
- Primary Endpoint
- Percent excess weight loss following bariatric surgery
Study Overview
Brief 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 25 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •BMI between 40 and 60
- •age 25 to 65
- •ability to participate in weekly LEARN groups for 3 months at Mayo Clinic (local to the Rochester, MN area)
- •seeking RYGB procedure
Exclusion Criteria
- •patients seeking surgical revision of a previous bariatric procedure
- •diagnosis of schizophrenia
- •diagnosis of bipolar disorder
- •diagnosis of borderline personality disorder
- •non-local patients
Outcomes
Primary Outcomes
Percent excess weight loss following bariatric surgery
Time Frame: 6 months post-surgery
The study will compare percent excess weight loss between the two groups (behavioral intervention vs. control)
Secondary Outcomes
- Psychosocial outcomes(6 months post-surgery)
- Resolution of medical comorbidities(6 months post-surgery)
Investigators
Karen Grothe
Karen Grothe, PhD
Mayo Clinic