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Behavior Therapy Prior to Bariatric Surgery

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Mayo Clinic

Status and phase

Completed
Phase 1

Conditions

Obesity

Treatments

Behavioral: LEARN group

Study type

Interventional

Funder types

Other

Identifiers

NCT01125397
FP00054166
09-007135

Details and patient eligibility

About

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.

Enrollment

34 patients

Sex

All

Ages

25 to 65 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

34 participants in 2 patient groups

Behavioral Intervention
Experimental group
Treatment:
Behavioral: LEARN group
Control
No Intervention group
Description:
These participants will be randomized to receive no behavioral intervention prior to bariatric surgery.

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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