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

• 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: Stanford University
• Collaborator: National Institute of Mental Health (NIMH)
• Information provided by (Responsible Party): Debra L. Safer, Stanford University

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	Phase
Overweight; Eating Disorders	Behavioral: Emotion regulation group therapy; Drug: Orlistat/alli program	Not Applicable

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
• Actual Primary Completion Date: November 2008
• Actual Study Completion Date: December 2008

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

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• 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

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
• Other Study ID Numbers: K23MH066330 ( U.S. NIH Grant/Contract ); K23MH066330 ( U.S. NIH Grant/Contract )
• First Posted: January 28, 2008
• 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; Body Weight; Mental Disorders; Orlistat; Enzyme Inhibitors; Molecular Mechanisms of Pharmacological Action; Anti-Obesity Agents; Lipid Regulating Agents