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This study will evaluate the efficacy of a multifactorial approach associated with orlistat (Xenical) in weight loss maintenance during 4 years. The effect of orlistat in combination with diet, physical activity, and/or cognitive behavioral therapy will be monitored.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Orlistat | Experimental | Participants will receive intermittent orlistat for up to 4 years, with the dose determined according to body weight changes. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Orlistat | Drug | Participants will receive orlistat on an intermittent basis as 120 milligrams (mg) three times a day: once with breakfast, once with lunch, and once with dinner. In case of weight relapse (increase 2.5 percent [%] or more from Baseline) orlistat will be administered for up to 2 months or until weight regain reaches 0% from Baseline. For special occasions (feasts, birthdays, anniversaries) orlistat will be given for up to 3 days. |
| Measure | Description | Time Frame |
|---|---|---|
| Percent Change from Baseline in Body Weight at Year 2 | Baseline and Year 2 | |
| Percent Change from Baseline in Body Weight at Year 4 | Baseline and Year 4 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Diagnosed with Binge Eating Disorder According to Diagnostic and Statistical Manual of Mental Disorders (DSM) IV Criteria | Every 6 months during Year 1, annually during Years 2 to 4 | |
| Eating Disorder Inventory (EDI) 2 Subscale and Total Score |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Hoffmann-La Roche | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Geneva | 1211 | Switzerland |
| Type | Date | Date Unknown |
|---|---|---|
| Release | Aug 3, 2016 | |
| Reset | Sep 23, 2016 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Aug 3, 2016 | Sep 23, 2016 |
| ID | Term |
|---|---|
| D009765 | Obesity |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D000077403 | Orlistat |
| ID | Term |
|---|---|
| D007783 | Lactones |
| D009930 | Organic Chemicals |
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|
| Baseline and Year 4 |
| Hospital Anxiety and Depression (HAD) Subscale Score | Baseline and Year 4 |
| Number of Orlistat Capsules Taken During the Study | Given up to three times per day for 4 years |
| Duration of Orlistat Treatment During the Study | Given up to three times per day for 4 years |
| Waist-to-Hip Circumference Ratio | Baseline and Year 4 |
| Waist, Hip, Wrist, and Arm Circumference (Expressed in Centimeters) | Baseline and Year 4 |
| Skinfold Thickness (Expressed in Millimeters) | Baseline and Year 4 |
| Bioelectrical Impedance (Expressed in Kilograms of Body Fat Mass) | Baseline and Year 4 |
| Number of Kilocalories Expended, Total and at Rest | Baseline and Year 4 |
| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |