Official Title: “Comparing Orlistat/Alli to Orlistat/Alli Plus Guided Self-Help Group Therapy in Overweight Binge Eaters”

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.

Study Type: Interventional

Study Design: Treatment, Randomized, Single Blind (Outcomes Assessor), Active Control, Parallel Assignment, Efficacy Study

Study Primary Completion Date: November 2008

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.

Intervention(s) in this Clinical Trial

• Behavioral: Emotion regulation guided self-help group therapy
  • Emotion regulation guided self-help group therapy involves twelve 2-hour sessions of guided self-help group psychotherapy.
• 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.

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: 1
  • 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
• Active Comparator: 2
  • Group taking the weight loss medication orlistat (alli), in conjunction with the alli weight loss program alone

Primary Measures

• Weight loss
  • Time Frame: Measured at Month 9
    Safety Issue?: No

Secondary Measures

• Binge frequency
  • Time Frame: Measured at Month 9
    Safety Issue?: No

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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: National Institute of Mental Health (NIMH)

Overall Clinical Trial Officials and Contacts

Debra L. Safer, MD Principal Investigator Stanford University Department of Psychiatry  

Information obtained from ClinicalTrials.gov on July 02, 2009

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00601354

Study ID Number: K23 MH066330

ClinicalTrials.gov Identifier: NCT00601354

Health Authority: United States: Federal Government