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| Name | Class |
|---|---|
| American Psychological Foundation | OTHER |
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This study will examine behavioral and pharmacologic (Naltrexone+Bupropion) treatments for weight regain after bariatric surgery.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Behavioral Weight Loss | Experimental |
| |
| Behavioral Weight Loss + Medication | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Behavioral Weight Loss (BWL) | Behavioral | All participants will receive twelve weeks of BWL treatment. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Body Mass Index | BMI is calculated using measured height and weight- kg/m2. | Post-treatment (3 months) |
| Measure | Description | Time Frame |
|---|---|---|
| Eating Disorder Psychopathology | Eating-disorder psychopathology is a continuous variable as assessed by the global score of the Eating Disorder Examination/Eating Disorder Examination-Questionnaire. Scores range from 0-6 (0=no eating-disorder psychopathology; 6=severe eating-disorder psychopathology). | Post-treatment (3 months) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Yale University | New Haven | Connecticut | 06511 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Behavioral Weight Loss | Behavioral Weight Loss (BWL): All participants will receive twelve weeks of BWL treatment. Early Responder: BWL continued: Participants categorized as experiencing early weight loss at the end of the first month of treatment will continue with BWL for the remainder of treatment. |
| FG001 | Behavioral Weight Loss + Medication | Behavioral Weight Loss (BWL): All participants will receive twelve weeks of BWL treatment. Early Non-responder: BWL continued with medication added: Participants categorized as not experiencing early weight loss at the end of the first month of treatment will continue BWL plus a weight loss medication (Naltrexone Bupropion) for the remainder of treatment. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Behavioral Weight Loss | Behavioral Weight Loss (BWL): All participants will receive twelve weeks of BWL treatment. Early Responder: BWL continued: Participants categorized as experiencing early weight loss at the end of the first month of treatment will continue with BWL for the remainder of treatment. |
| BG001 |
| 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 | Body Mass Index | BMI is calculated using measured height and weight- kg/m2. | Participants with complete data at follow up. | Posted | Mean | Standard Deviation | kg/m2 | Post-treatment (3 months) |
|
Up to 3 months
Adverse events were collected for both arms however, the on label listed potential side effects for the drug were used to assess participants in the '+ drug' arm systematically.
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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 | Behavioral Weight Loss | Behavioral Weight Loss (BWL): All participants will receive twelve weeks of BWL treatment. Early Responder: BWL continued: Participants categorized as experiencing early weight loss at the end of the first month of treatment will continue with BWL for the remainder of treatment. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diarrhea | Gastrointestinal disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr Valentina Ivezaj, Assistant Professor of Psychiatry | Yale School of Medicine | +1 (203) 785-7807 | valentina.ivezaj@yale.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Nov 30, 2021 | Oct 19, 2023 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D009765 | Obesity |
| D050177 | Overweight |
| ID | Term |
|---|---|
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
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| Early Responder: BWL continued | Behavioral | Participants categorized as experiencing early weight loss at the end of the first month of treatment will continue with BWL for the remainder of treatment. |
|
| Early Non-responder: BWL continued with medication added | Combination Product | Participants categorized as not experiencing early weight loss at the end of the first month of treatment will continue BWL plus a weight loss medication (Naltrexone Bupropion) for the remainder of treatment. |
|
| Food Craving |
Food craving will be assessed by the Food Craving Inventory (FCI). FCI scores range from 1-5, with higher scores indicative of greater craving. |
| Post-treatment (3 months) |
| Depressive Symptoms | Depressive symptoms will be assessed by the Patient Health Questionnaire-9. The range is 0-27, which higher scores indicative of greater depressive symptomatology | Post-treatment (3 months) |
| Behavioral Weight Loss + Medication |
Behavioral Weight Loss (BWL): All participants will receive twelve weeks of BWL treatment. Early Non-responder: BWL continued with medication added: Participants categorized as not experiencing early weight loss at the end of the first month of treatment will continue BWL plus a weight loss medication (Naltrexone Bupropion) for the remainder of treatment. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
|
|
|
| Secondary | Eating Disorder Psychopathology | Eating-disorder psychopathology is a continuous variable as assessed by the global score of the Eating Disorder Examination/Eating Disorder Examination-Questionnaire. Scores range from 0-6 (0=no eating-disorder psychopathology; 6=severe eating-disorder psychopathology). | Participants with complete data at follow up- 1 participant did not complete questionnaires in the Behavioral Weight Loss + Medication group at follow up. | Posted | Mean | Standard Deviation | units on a scale | Post-treatment (3 months) |
|
|
|
| Secondary | Food Craving | Food craving will be assessed by the Food Craving Inventory (FCI). FCI scores range from 1-5, with higher scores indicative of greater craving. | Participants with complete data at follow up- 1 participant did not complete questionnaires in the Behavioral Weight Loss + Medication group at follow up. | Posted | Mean | Standard Deviation | units on a scale | Post-treatment (3 months) |
|
|
|
| Secondary | Depressive Symptoms | Depressive symptoms will be assessed by the Patient Health Questionnaire-9. The range is 0-27, which higher scores indicative of greater depressive symptomatology | Participants with complete data at follow up- 1 participant did not complete questionnaires in the Behavioral Weight Loss + Medication group at follow up. | Posted | Mean | Standard Deviation | units on a scale | Post-treatment (3 months) |
|
|
|
| 0 |
| 12 |
| 0 |
| 12 |
| 0 |
| 12 |
| EG001 | Behavioral Weight Loss + Medication | Behavioral Weight Loss (BWL): All participants will receive twelve weeks of BWL treatment. Early Non-responder: BWL continued with medication added: Participants categorized as not experiencing early weight loss at the end of the first month of treatment will continue BWL plus a weight loss medication (Naltrexone Bupropion) for the remainder of treatment. | 0 | 10 | 0 | 10 | 7 | 10 |
| Constipation | Gastrointestinal disorders | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | Systematic Assessment |
|
| Dizziness | General disorders | Systematic Assessment |
|
| Dry mouth | General disorders | Systematic Assessment |
|
| Headache | General disorders | Systematic Assessment |
|
| Insomnia | General disorders | Systematic Assessment |
|
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| D012816 |
| Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |