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Clinical Trials/NCT01125397
NCT01125397
Completed
Phase 1

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

Mayo Clinic1 site in 1 country34 target enrollmentNovember 2009
ConditionsObesity

Overview

Phase
Phase 1
Intervention
Not specified
Conditions
Obesity
Sponsor
Mayo Clinic
Enrollment
34
Locations
1
Primary Endpoint
Percent excess weight loss following bariatric surgery
Status
Completed
Last Updated
12 years ago

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.

Registry
clinicaltrials.gov
Start Date
November 2009
End Date
October 2012
Last Updated
12 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Karen Grothe

Karen Grothe, PhD

Mayo Clinic

Eligibility Criteria

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)

Study Sites (1)

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