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Behavior Therapy Prior to Bariatric Surgery

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Karen Grothe, Mayo Clinic
ClinicalTrials.gov Identifier:
NCT01125397
First received: May 17, 2010
Last updated: May 8, 2013
Last verified: May 2013
History of Changes
  Purpose

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.


Condition Intervention Phase
Obesity
 Behavioral: LEARN group
 Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: The Potential Effectiveness of Behavior Therapy on Weight Loss Following Bariatric Surgery

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Mayo Clinic:

Primary Outcome Measures:
  • Percent excess weight loss following bariatric surgery [ Time Frame: 6 months post-surgery ] [ Designated as safety issue: No ]
    The study will compare percent excess weight loss between the two groups (behavioral intervention vs. control)


Secondary Outcome Measures:
  • Psychosocial outcomes [ Time Frame: 6 months post-surgery ] [ Designated as safety issue: No ]
    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.

  • Resolution of medical comorbidities [ Time Frame: 6 months post-surgery ] [ Designated as safety issue: No ]
    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.


Enrollment: 34
Study Start Date: November 2009
Study Completion Date: October 2012
Primary Completion Date: October 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   25 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01125397

Locations
United States, Minnesota
Mayo Clinic
Rochester, Minnesota, United States, 55905
Sponsors and Collaborators
Mayo Clinic
Investigators
Principal Investigator: Karen B Grothe, PhD Mayo Clinic
  More Information

No publications provided

Responsible Party: Karen Grothe, Karen Grothe, PhD, Mayo Clinic
ClinicalTrials.gov Identifier: NCT01125397     History of Changes
Other Study ID Numbers: 09-007135, FP00054166
Study First Received: May 17, 2010
Last Updated: May 8, 2013
Health Authority: United States: Institutional Review Board
United States: Food and Drug Administration

Keywords provided by Mayo Clinic:
bariatric surgery
behavioral weight management
psychosocial outcomes following bariatric surgery

Additional relevant MeSH terms:
Obesity
Overnutrition
Nutrition Disorders
 Overweight
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on May 23, 2013