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

Primary Purpose

Overweight, Eating Disorders

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Emotion regulation group therapy
Orlistat/alli program
Sponsored by
Stanford University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Overweight focused on measuring Binge Eating, Orlistat, Alli, Guided Self-Help

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Stanford University School of Medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Emotion Regulation Group therapy + alli

Orlistat/alli program meds only

Arm Description

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

Group taking the weight loss medication orlistat (alli), in conjunction with the alli weight loss program alone

Outcomes

Primary Outcome Measures

Weight Loss
Change in weight in lbs from per to post treatment

Secondary Outcome Measures

Binge Frequency
frequency of objective binge days over prior 28 days

Full Information

First Posted
January 4, 2008
Last Updated
June 26, 2013
Sponsor
Stanford University
Collaborators
National Institute of Mental Health (NIMH)
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1. Study Identification

Unique Protocol Identification Number
NCT00601354
Brief Title
Adding Guided Self-Help Group Therapy to the Alli Weight Loss Program in Treating Binge Eating Disorder
Official Title
Comparing Orlistat/Alli to Orlistat/Alli Plus Guided Self-help Group Therapy in Overweight Binge Eaters
Study Type
Interventional

2. Study Status

Record Verification Date
June 2013
Overall Recruitment Status
Completed
Study Start Date
September 2007 (undefined)
Primary Completion Date
November 2008 (Actual)
Study Completion Date
December 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Stanford University
Collaborators
National Institute of Mental Health (NIMH)

4. Oversight

Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Overweight, Eating Disorders
Keywords
Binge Eating, Orlistat, Alli, Guided Self-Help

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
17 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Emotion Regulation Group therapy + alli
Arm Type
Experimental
Arm Description
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
Arm Title
Orlistat/alli program meds only
Arm Type
Active Comparator
Arm Description
Group taking the weight loss medication orlistat (alli), in conjunction with the alli weight loss program alone
Intervention Type
Behavioral
Intervention Name(s)
Emotion regulation group therapy
Other Intervention Name(s)
emotion regulation guided self-help group therapy
Intervention Description
Emotion regulation guided self-help group therapy involves twelve 2-hour sessions of guided self-help group psychotherapy.
Intervention Type
Drug
Intervention Name(s)
Orlistat/alli program
Other Intervention Name(s)
Alli
Intervention Description
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.
Primary Outcome Measure Information:
Title
Weight Loss
Description
Change in weight in lbs from per to post treatment
Time Frame
3 months: Measured from pre to post treatment
Secondary Outcome Measure Information:
Title
Binge Frequency
Description
frequency of objective binge days over prior 28 days
Time Frame
3 months: Measured from pre to post treatment
Other Pre-specified Outcome Measures:
Title
Weeks of Adherence to Orlistat
Time Frame
Number of adherent weeks over 1 year study

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Debra L. Safer, MD
Organizational Affiliation
Stanford University Department of Psychiatry
Official's Role
Principal Investigator
Facility Information:
Facility Name
Stanford University School of Medicine
City
Stanford
State/Province
California
ZIP/Postal Code
94305
Country
United States

12. IPD Sharing Statement

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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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