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

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ClinicalTrials.gov Identifier: NCT00601354
Recruitment Status : Completed
First Posted : January 28, 2008
Results First Posted : September 9, 2013
Last Update Posted : September 9, 2013
Sponsor:
Collaborator:
Information provided by (Responsible Party):

Study Description
Brief Summary:
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 or disease Intervention/treatment
Overweight Eating Disorders Behavioral: Emotion regulation group therapy Drug: Orlistat/alli program

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.


Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 17 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Comparing Orlistat/Alli to Orlistat/Alli Plus Guided Self-help Group Therapy in Overweight Binge Eaters
Study Start Date : September 2007
Primary Completion Date : November 2008
Study Completion Date : December 2008

Resource links provided by the National Library of Medicine

Drug Information available for: Orlistat
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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


Outcome Measures

Primary Outcome Measures :
  1. Weight Loss [ Time Frame: 3 months: Measured from pre to post treatment ]
    Change in weight in lbs from per to post treatment


Secondary Outcome Measures :
  1. Binge Frequency [ Time Frame: 3 months: Measured from pre to post treatment ]
    frequency of objective binge days over prior 28 days


Other Outcome Measures:
  1. Weeks of Adherence to Orlistat [ Time Frame: Number of adherent weeks over 1 year study ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00601354


Locations
United States, California
Stanford University School of Medicine
Stanford, California, United States, 94305
Sponsors and Collaborators
Stanford University
National Institute of Mental Health (NIMH)
Investigators
Principal Investigator: Debra L. Safer, MD Stanford University Department of Psychiatry
More Information

Responsible Party: Debra L. Safer, PI, Stanford University
ClinicalTrials.gov Identifier: NCT00601354     History of Changes
Other Study ID Numbers: K23MH066330 ( U.S. NIH Grant/Contract )
First Posted: January 28, 2008    Key Record Dates
Results First Posted: September 9, 2013
Last Update Posted: September 9, 2013
Last Verified: June 2013

Keywords provided by Debra L. Safer, Stanford University:
Binge Eating
Orlistat
Alli
Guided Self-Help

Additional relevant MeSH terms:
Overweight
Feeding and Eating Disorders
Binge-Eating Disorder
Body Weight
Signs and Symptoms
Mental Disorders
Orlistat
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Obesity Agents