ClinicalTrials.gov
 Home    Search    Study Topics    Glossary  
 

  Full Text View  
  Tabular View  
  Contacts and Locations  
  No Study Results Posted  
  Related Studies  
Adding Guided Self-Help Group Therapy to the Alli Weight Loss Program in Treating Binge Eating Disorder

This study is ongoing, but not recruiting participants.

Sponsored by: National Institute of Mental Health (NIMH)
Information provided by: National Institute of Mental Health (NIMH)
ClinicalTrials.gov Identifier: NCT00601354
  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 guided self-help group therapy
Drug: Orlistat/alli program

MedlinePlus related topics:   Eating Disorders    Weight Control   

Drug Information available for:   Orlistat   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Randomized, Single Blind (Outcomes Assessor), Active Control, Parallel Assignment, Efficacy Study
Official Title:   Comparing Orlistat/Alli to Orlistat/Alli Plus Guided Self-Help Group Therapy in Overweight Binge Eaters

Further study details as provided by National Institute of Mental Health (NIMH):

Primary Outcome Measures:
  • Weight loss [ Time Frame: Measured at Month 9 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Binge frequency [ Time Frame: Measured at Month 9 ] [ Designated as safety issue: No ]

Estimated Enrollment:   17
Study Start Date:   October 2007
Estimated Study Completion Date:   December 2008
Estimated Primary Completion Date:   November 2008 (Final data collection date for primary outcome measure)

Arms Assigned Interventions
1: Experimental
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 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.
2: Active Comparator
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.

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

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

Investigators
Principal Investigator:     Debra L. Safer, MD     Stanford University Department of Psychiatry    
  More Information


Responsible Party:   Stanford University School of Medicine ( Debra L. Safer MD )
Study ID Numbers:   K23 MH066330, 98267, DSIR 83-ATAS
First Received:   January 4, 2008
Last Updated:   September 18, 2008
ClinicalTrials.gov Identifier:   NCT00601354
Health Authority:   United States: Federal Government

Keywords provided by National Institute of Mental Health (NIMH):
Binge Eating  
Orlistat  
Alli  
Guided Self-Help  

Study placed in the following topic categories:
Body Weight
Signs and Symptoms
Bulimia Nervosa
Orlistat
Mental Disorders
Bulimia
Weight Loss
Overweight
Eating Disorders

Additional relevant MeSH terms:
Anti-Obesity Agents
Pathologic Processes
Disease
Molecular Mechanisms of Pharmacological Action
Therapeutic Uses
Enzyme Inhibitors
Central Nervous System Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on November 20, 2008




Links to all studies - primarily for crawlers