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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

January 4, 2008
June 26, 2013
September 2007
November 2008   (final data collection date for primary outcome measure)
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
Weight loss [ Time Frame: Measured at Month 9 ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00601354 on ClinicalTrials.gov Archive Site
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
Binge frequency [ Time Frame: Measured at Month 9 ] [ Designated as safety issue: No ]
Weeks of Adherence to Orlistat [ Time Frame: Number of adherent weeks over 1 year study ] [ Designated as safety issue: No ]
Not Provided
 
Adding Guided Self-Help Group Therapy to the Alli Weight Loss Program in Treating Binge Eating Disorder
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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
  • Overweight
  • Eating Disorders
  • 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
  • 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
    Interventions:
    • Behavioral: Emotion regulation group therapy
    • Drug: Orlistat/alli program
  • Active Comparator: Orlistat/alli program meds only
    Group taking the weight loss medication orlistat (alli), in conjunction with the alli weight loss program alone
    Intervention: Drug: Orlistat/alli program
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
17
December 2008
November 2008   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00601354
K23 MH066330, K23MH066330
No
Debra L. Safer, Stanford University
Stanford University
National Institute of Mental Health (NIMH)
Principal Investigator: Debra L. Safer, MD Stanford University Department of Psychiatry
Stanford University
June 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP