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| ID | Type | Description | Link |
|---|---|---|---|
| K23MH066330 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Mental Health (NIMH) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Emotion Regulation Group therapy + alli | 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 |
|
| Orlistat/alli program meds only | Active Comparator | Group taking the weight loss medication orlistat (alli), in conjunction with the alli weight loss program alone |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Emotion regulation group therapy | Behavioral | Emotion regulation guided self-help group therapy involves twelve 2-hour sessions of guided self-help group psychotherapy. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Weight Loss | Change in weight in lbs from per to post treatment | 3 months: Measured from pre to post treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Binge Frequency | frequency of objective binge days over prior 28 days | 3 months: Measured from pre to post treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Weeks of Adherence to Orlistat | Number of adherent weeks over 1 year study |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Debra L. Safer, MD | Stanford University Department of Psychiatry | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Stanford University School of Medicine | Stanford | California | 94305 | United States |
There was no wash out, run-in, or transition following participant enrollment.Exclusion criteria are described previously. Main exclusion was weight less than 27 kg/m2.
Participants were recruited through newspaper advertisements and flyers. The study took place at an outpatient psychiatry department of a large university medical center.
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| ID | Title | Description |
|---|---|---|
| FG000 | OTC Orlistat + Guided Self-help Affect Regulation | 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 |
| FG001 | OTC Orlistat /Medication Management Alone | Group taking the weight loss medication orlistat (alli), in conjunction with the alli weight loss program alone |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | OTC Orlistat + Guided Self-help Affect Regulation | 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 |
| BG001 | OTC Orlistat /Medication Management Alone |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Weight Loss | Change in weight in lbs from per to post treatment | Used intent-to-treat analysis | Posted | Mean | Standard Deviation | lbs | 3 months: Measured from pre to post treatment |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | OTC Orlistat + Guided Self-help Affect Regulation | 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 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Debra L Safer | Stanford University | 650-723-7928 | dlsafer@stanford.edu |
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| ID | Term |
|---|---|
| D050177 | Overweight |
| D001068 | Feeding and Eating Disorders |
| D002032 | Bulimia |
| ID | Term |
|---|---|
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
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| ID | Term |
|---|---|
| D000077403 | Orlistat |
| ID | Term |
|---|---|
| D007783 | Lactones |
| D009930 | Organic Chemicals |
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| Orlistat/alli program | 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. |
|
|
Group taking the weight loss medication orlistat (alli), in conjunction with the alli weight loss program alone |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Secondary | Binge Frequency | frequency of objective binge days over prior 28 days | Intent to treat | Posted | Mean | Standard Deviation | % change objective binge days | 3 months: Measured from pre to post treatment |
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| Other Pre-specified | Weeks of Adherence to Orlistat | Intent to treat | Posted | Mean | Standard Deviation | week of adherence to orlistat | Number of adherent weeks over 1 year study |
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| 0 |
| 8 |
| 0 |
| 8 |
| EG001 | OTC Orlistat /Medication Management Alone | Group taking the weight loss medication orlistat (alli), in conjunction with the alli weight loss program alone | 0 | 9 | 0 | 9 |
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| D012816 |
| Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012817 | Signs and Symptoms, Digestive |
| D001523 | Mental Disorders |
| D006963 | Hyperphagia |