Behavior Therapy Prior to Bariatric Surgery

Study Overview
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Brief Summary
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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.

Official Title
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The Potential Effectiveness of Behavior Therapy on Weight Loss Following Bariatric Surgery

Conditions
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Obesity

Intervention / Treatment
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* Behavioral: LEARN group


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 25 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Behavioral Intervention<br> | Behavioral: LEARN group<br>* Participants will complete a 12-week behavioral weight management intervention (the LEARN program) prior to bariatric surgery, which is the current standard clinical practice at Mayo Clinic Rochester. This involves weekly group meetings, weigh-ins, and goal setting.<br>|
| No Intervention: Control<br>These participants will be randomized to receive no behavioral intervention prior to bariatric surgery. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent excess weight loss following bariatric surgery | The study will compare percent excess weight loss between the two groups (behavioral intervention vs. control) | 6 months post-surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Psychosocial outcomes | Psychological outcomes that will be assessed at baseline and 6 months postoperatively include quality of life (SF-36), depression (BDI-II, PHQ-9), anxiety (GAD-7), alcohol use (AUDIT), distress tolerance (DTS), emotional eating (EOQ), and eating self-efficacy (WEL). All questionnaires are validated and possess good psychometric properties. All measures except the SF-36 are currently given as routine practice during psychological evaluations of bariatric patients, enhancing feasibility for the current study. | 6 months post-surgery | 
| Resolution of medical comorbidities | Resolution rates of comorbidities will be assessed 6 months post-surgery defined as follows: diabetes as no longer requiring medication and A1C level <7, hypertension as no longer requiring medication and blood pressure of <140 mm Hg (systolic)/90 mm Hg (diastolic). Patients are typically seen at 2 and 6 weeks postoperatively in the surgery clinic and 3 and 6 months in Endocrinology, therefore percentage of follow-up will be calculated as appointments attended/appointments scheduled. Time from initial evaluation until surgery will also be assessed as a possible covariate. | 6 months post-surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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bariatric surgery, behavioral weight management, psychosocial outcomes following bariatric surgery