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| ID | Type | Description | Link |
|---|---|---|---|
| R01DK049587 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | NIH |
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This controlled study will test the effectiveness of a stepped-care approach to a standard behavioral weight loss treatment for obese patients with Binge Eating Disorder (BED). The major question is whether the stepped-care approach, which begins with behavioral weight loss and then follows a decision tree for additional interventions based on early treatment response is superior to standard behavioral treatment.
The stepped-care arm of this study included an obesity medication intervention. At the start of the study, the active medication was sibutramine and was compared to a placebo control. On 10/8/2010, Abbott Laboratories withdrew their obesity drug sibutramine (Meridia) from the market in light of clinical trial data pointing to an increased risk for stroke and myocardial infarction. In response to this event, the investigators submitted an IRB amendment to change the active obesity medication from sibutramine to Orlistat. The IRB amendment was approved on 11/4/2010. The PI received approval from NIH/NIDDK Program Officer Robert Kuczmarski to enact this change.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Active Comparator | Standard Care |
|
| 2 | Experimental | Stepped-care |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Behavioral Weight Loss | Behavioral | weekly individual sessions for 6 months |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Subjects Who Reached Binge Eating Remission | Binge Remission (abstinence from binge eating) | 12 months follow-up |
| Measure | Description | Time Frame |
|---|---|---|
| BMI | The body mass index is a value derived from the mass and height of an individual. The BMI is defined as the body mass divided by the square of the body height, and is universally expressed in units of kg/m^2. | 12 months follow-up post-treatment |
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Inclusion criteria:
Exclusion criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Carlos M Grilo, PhD | Yale University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Yale School of Medicine | New Haven | Connecticut | 06520 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32985114 | Derived | Grilo CM, White MA, Ivezaj V, Gueorguieva R. Randomized Controlled Trial of Behavioral Weight Loss and Stepped Care for Binge-Eating Disorder: 12-Month Follow-up. Obesity (Silver Spring). 2020 Nov;28(11):2116-2124. doi: 10.1002/oby.22975. Epub 2020 Sep 27. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Standard Care | Standard Care Behavioral Weight Loss: weekly individual sessions for 6 months |
| FG001 | Stepped-care | Stepped-care Behavioral Weight Loss: weekly individual sessions for 6 months Behavioral Weight Loss + Guided self-help Cognitive-behavioral Therapy: weekly BWL sessions for 4 weeks and 6-8 CBT sessions for 5 months Placebo: One pill daily Sibutramine/Orlistat: Sibutramine 15 mg daily or Orlistat 120mg TID |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Standard Care | Standard Care Behavioral Weight Loss: weekly individual sessions for 6 months |
| BG001 | Stepped-care | Stepped-care Behavioral Weight Loss: weekly individual sessions for 6 months Behavioral Weight Loss + Guided self-help Cognitive-behavioral Therapy: weekly BWL sessions for 4 weeks and 6-8 CBT sessions for 5 months Placebo: One pill daily Sibutramine/Orlistat: Sibutramine 15 mg daily or Orlistat 120mg TID |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Number of Subjects Who Reached Binge Eating Remission | Binge Remission (abstinence from binge eating) | Posted | Number | participants | 12 months follow-up |
|
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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 | Standard Care | Standard Care Behavioral Weight Loss: weekly individual sessions for 6 months |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Carlos Grilo | Yale School of Medicine | 203-785-2792 | carlos.grilo@yale.edu |
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| ID | Term |
|---|---|
| D009765 | Obesity |
| D002032 | Bulimia |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| C058254 | sibutramine |
| D000077403 | Orlistat |
| ID | Term |
|---|---|
| D007783 | Lactones |
| D009930 | Organic Chemicals |
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| Behavioral Weight Loss + Guided self-help Cognitive-behavioral Therapy |
| Behavioral |
weekly BWL sessions for 4 weeks and 6-8 CBT sessions for 5 months |
|
| Placebo | Drug | One pill daily |
|
| Sibutramine/Orlistat | Drug | Sibutramine 15 mg daily or Orlistat 120mg TID |
|
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Number | participants |
|
| BMI | Mean | Standard Deviation | kg/m^2 |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Secondary | BMI | The body mass index is a value derived from the mass and height of an individual. The BMI is defined as the body mass divided by the square of the body height, and is universally expressed in units of kg/m^2. | Posted | Mean | Standard Deviation | kg/m^2 | 12 months follow-up post-treatment |
|
|
|
| 0 |
| 39 |
| 0 |
| 39 |
| EG001 | Stepped-care | Stepped-care Behavioral Weight Loss: weekly individual sessions for 6 months Behavioral Weight Loss + Guided self-help Cognitive-behavioral Therapy: weekly BWL sessions for 4 weeks and 6-8 CBT sessions for 5 months Placebo: One pill daily Sibutramine/Orlistat: Sibutramine 15 mg daily or Orlistat 120mg TID | 0 | 152 | 0 | 152 |
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| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D006963 | Hyperphagia |
| D012817 | Signs and Symptoms, Digestive |