Behavior Therapy Prior to Bariatric Surgery

NCT ID: NCT01125397

Last Updated: 2013-05-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 34 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-11-30
• Study Completion Date: 2012-10-31

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Behavioral Intervention

Group Type: EXPERIMENTAL

LEARN group

Intervention Type: 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.

Control

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 25 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Mayo Clinic

OTHER

Sponsor Role: lead

Responsible Party

Karen Grothe

Karen Grothe, PhD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Karen B Grothe, PhD

Role: PRINCIPAL_INVESTIGATOR

Mayo Clinic

Locations

Mayo Clinic

Rochester, Minnesota, United States

Countries

United States

Other Identifiers

FP00054166

Identifier Type: -

Identifier Source: secondary_id

09-007135

Identifier Type: -

Identifier Source: org_study_id