Adding Guided Self-Help Group Therapy to the Alli Weight Loss Program in Treating Binge Eating Disorder

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Debra L. Safer, Stanford University
ClinicalTrials.gov Identifier:
NCT00601354
First received: January 4, 2008
Last updated: June 26, 2013
Last verified: June 2013
  Purpose

This study will evaluate the effectiveness of adding guided self-help group therapy to a weight loss program in achieving weight loss and reducing binge eating in overweight binge eaters.


Condition Intervention
Overweight
Eating Disorders
Behavioral: Emotion regulation group therapy
Drug: Orlistat/alli program

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Comparing Orlistat/Alli to Orlistat/Alli Plus Guided Self-help Group Therapy in Overweight Binge Eaters

Resource links provided by NLM:


Further study details as provided by Stanford University:

Primary Outcome Measures:
  • Weight Loss [ Time Frame: 3 months: Measured from pre to post treatment ] [ Designated as safety issue: No ]
    Change in weight in lbs from per to post treatment


Secondary Outcome Measures:
  • Binge Frequency [ Time Frame: 3 months: Measured from pre to post treatment ] [ Designated as safety issue: No ]
    frequency of objective binge days over prior 28 days


Other Outcome Measures:
  • Weeks of Adherence to Orlistat [ Time Frame: Number of adherent weeks over 1 year study ] [ Designated as safety issue: No ]

Enrollment: 17
Study Start Date: September 2007
Study Completion Date: December 2008
Primary Completion Date: November 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Emotion Regulation Group therapy + alli
Group taking the weight loss medication orlistat (alli), in conjunction with the alli weight loss program, plus 12 weekly sessions of guided self-help group psychotherapy
Behavioral: Emotion regulation group therapy
Emotion regulation guided self-help group therapy involves twelve 2-hour sessions of guided self-help group psychotherapy.
Other Name: emotion regulation guided self-help group therapy
Drug: Orlistat/alli program
The orlistat/alli program involves taking 60 mg orlistat three times a day and participating in the alli program, a comprehensive behavioral weight loss program with online access.
Other Name: Alli
Active Comparator: Orlistat/alli program meds only
Group taking the weight loss medication orlistat (alli), in conjunction with the alli weight loss program alone
Drug: Orlistat/alli program
The orlistat/alli program involves taking 60 mg orlistat three times a day and participating in the alli program, a comprehensive behavioral weight loss program with online access.
Other Name: Alli

Detailed Description:

Binge eating disorder is one of the most common eating disorders, with more than 4 million Americans affected. Following a binge eating episode, in which a person eats an excessive amount of food in a short period of time, the person often experiences feelings of guilt, depression, embarrassment, and disgust. Beyond the emotional distress caused by binge eating, people who binge eat are at a higher risk for more serious health problems associated with weight gain. These health problems may include high blood pressure, diabetes, heart disease, high cholesterol, and certain types of cancer. Thus, seeking effective treatment for binge eating disorder is vital to an affected person's overall physical and mental well-being. Managed weight loss programs, combined with certain forms of psychotherapy, have shown success in providing the direction and proper motivation to eat healthily and to prevent future binge eating episodes. This study will evaluate the effectiveness of adding guided self-help group therapy to the alli weight loss program in achieving weight loss and reducing binge eating in overweight binge eaters.

Participation in this single-blind study will last 36 weeks. Initial assessments will be divided over two 1- to 2-hour sessions. These assessments will include a history of any medical illness, height and weight measurements, and an eating disorder evaluation. Participants will also answer several questionnaires about self-esteem, feelings of depression, and emotion and eating. Participants will then be randomly assigned to one of two treatment groups: the alli program with the use of the weight loss drug orlistat or the alli program with the use of orlistat plus guided self-help group psychotherapy. All participants will take the over-the-counter weight loss medication orlistat three times a day for 12 weeks in conjunction with the alli program, a comprehensive weight loss program with online access. Participants assigned to the psychotherapy group will also attend 12 weekly guided self-help group psychotherapy sessions. These sessions will include behavioral support for adapting to the lifestyle changes promoted by the alli weight loss program.

All participants will undergo 12 weeks of active participation, 18 weeks of maintenance, and 18 weeks of follow-up. At various intervals during the first 6 months of the study, participants will answer a short group of questions concerning current binge eating habits; adherence to prescribed food, activity, and medication plan; and emotional state. The initial assessments will be repeated at Weeks 12, 30, and 42.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Body mass index greater than 27
  • Binge eating at least two times per week during the 6 months prior to study entry

Exclusion Criteria:

  • Current psychosis
  • Current suicidal ideations
  • Pregnant
  • Receiving concurrent psychotherapy
  • Unstable on psychotropic medications for 3 months prior to study entry
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00601354

Locations
United States, California
Stanford University School of Medicine
Stanford, California, United States, 94305
Sponsors and Collaborators
Stanford University
Investigators
Principal Investigator: Debra L. Safer, MD Stanford University Department of Psychiatry
  More Information

No publications provided

Responsible Party: Debra L. Safer, PI, Stanford University
ClinicalTrials.gov Identifier: NCT00601354     History of Changes
Other Study ID Numbers: K23 MH066330, K23MH066330
Study First Received: January 4, 2008
Results First Received: June 18, 2013
Last Updated: June 26, 2013
Health Authority: United States: Federal Government

Keywords provided by Stanford University:
Binge Eating
Orlistat
Alli
Guided Self-Help

Additional relevant MeSH terms:
Bulimia
Eating Disorders
Overweight
Binge-Eating Disorder
Hyperphagia
Signs and Symptoms, Digestive
Signs and Symptoms
Mental Disorders
Body Weight
Orlistat
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Anti-Obesity Agents
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on July 28, 2014