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

NCT ID: NCT00601354

Last Updated: 2013-09-09

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

17 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-09-30

Study Completion Date

2008-12-31

Brief Summary

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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

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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.

Conditions

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Overweight Eating Disorders

Keywords

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Binge Eating Orlistat Alli Guided Self-Help

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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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

Group Type EXPERIMENTAL

Emotion regulation group therapy

Intervention Type BEHAVIORAL

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

Orlistat/alli program

Intervention Type DRUG

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.

Orlistat/alli program meds only

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

Group Type ACTIVE_COMPARATOR

Orlistat/alli program

Intervention Type DRUG

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.

Interventions

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Emotion regulation group therapy

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

Intervention Type BEHAVIORAL

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.

Intervention Type DRUG

Other Intervention Names

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emotion regulation guided self-help group therapy Alli

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Institute of Mental Health (NIMH)

NIH

Sponsor Role collaborator

Stanford University

OTHER

Sponsor Role lead

Responsible Party

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Debra L. Safer

PI

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Debra L. Safer, MD

Role: PRINCIPAL_INVESTIGATOR

Stanford University Department of Psychiatry

Locations

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Stanford University School of Medicine

Stanford, California, United States

Site Status

Countries

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United States

Other Identifiers

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K23MH066330

Identifier Type: NIH

Identifier Source: secondary_id

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K23MH066330

Identifier Type: NIH

Identifier Source: org_study_id

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