Behavior Therapy Prior to Bariatric Surgery
|ClinicalTrials.gov Identifier: NCT01125397|
Recruitment Status : Completed
First Posted : May 18, 2010
Last Update Posted : May 10, 2013
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.
|Condition or disease||Intervention/treatment||Phase|
|Obesity||Behavioral: LEARN group||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||34 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||The Potential Effectiveness of Behavior Therapy on Weight Loss Following Bariatric Surgery|
|Study Start Date :||November 2009|
|Primary Completion Date :||October 2012|
|Study Completion Date :||October 2012|
|Experimental: Behavioral Intervention||
Behavioral: LEARN group
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.
No Intervention: Control
These participants will be randomized to receive no behavioral intervention prior to bariatric surgery.
- 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)
- Psychosocial outcomes [ Time Frame: 6 months post-surgery ]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.
- Resolution of medical comorbidities [ Time Frame: 6 months post-surgery ]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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01125397
|United States, Minnesota|
|Rochester, Minnesota, United States, 55905|
|Principal Investigator:||Karen B Grothe, PhD||Mayo Clinic|