Behavior Therapy Prior to Bariatric Surgery

NCT01125397 | Completed Phase 1

• 2 other identifiers: 09-007135FP00054166
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

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.

Conditions

Obesity

Keywords

bariatric surgery; behavioral weight management; psychosocial outcomes following bariatric surgery

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Psychosocial outcomes

  6 months post-surgery

• Resolution of medical comorbidities

  6 months post-surgery

Study Arms (2)

Behavioral Intervention

EXPERIMENTAL

Behavioral: LEARN group

Control

NO INTERVENTION

These participants will be randomized to receive no behavioral intervention prior to bariatric surgery.

Interventions

LEARN group BEHAVIORAL

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.

Behavioral Intervention

Eligibility Criteria

• Age: 25 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• patients seeking surgical revision of a previous bariatric procedure
• diagnosis of schizophrenia
• diagnosis of bipolar disorder
• diagnosis of borderline personality disorder
• non-local patients

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Karen B Grothe, PhD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Karen Grothe, PhD

Study Record Dates

• First Submitted: May 17, 2010
• First Posted: May 18, 2010
• Study Start: November 1, 2009
• Primary Completion: October 1, 2012
• Study Completion: October 1, 2012
• Last Updated: May 10, 2013

Record last verified: 2013-05

Locations

US (1)