Behavior Therapy Prior to Bariatric Surgery

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

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 Overview

• Status: Completed
• Conditions: Obesity
• Intervention / Treatment: Behavioral: LEARN group

• Study Type: Interventional
• Enrollment (Actual): 34
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Minnesota
    • Rochester, Minnesota, United States, 55905
      • Mayo Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 25 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Mayo Clinic
• Investigators: Principal Investigator: Karen B Grothe, PhD, Mayo Clinic

Study record dates

Study Major Dates

• Study Start: November 1, 2009
• Primary Completion (Actual): October 1, 2012
• Study Completion (Actual): October 1, 2012

Study Registration Dates

• First Submitted: May 17, 2010
• First Submitted That Met QC Criteria: May 17, 2010
• First Posted (Estimate): May 18, 2010

Study Record Updates

• Last Update Posted (Estimate): May 10, 2013
• Last Update Submitted That Met QC Criteria: May 8, 2013
• Last Verified: May 1, 2013

More Information

Terms related to this study

• Keywords: bariatric surgery; behavioral weight management; psychosocial outcomes following bariatric surgery
• Other Study ID Numbers: 09-007135; FP00054166