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| ID | Type | Description | Link |
|---|---|---|---|
| R01DK098492-01A1 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | NIH |
This study will test the effectiveness of two distinct behavioral treatments for loss of control eating following bariatric surgery:
These treatments will be compared to Standard-of-Care.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard-of-Care | Active Comparator | Standard-of-care is the continuation of any treatment or recommendations participants receive from his/her bariatric surgeon/team. |
|
| Behavioral Weight Loss Treatment | Experimental | Guided self-help Behavioral Weight Loss Treatment |
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| Cognitive Behavioral Therapy | Experimental | Guided self-help Cognitive Behavioral Therapy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Standard-of-Care | Behavioral | Standard-of-Care with bariatric team. Participants will be encouraged to continue their care with their bariatric team. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Loss of Control Eating Frequency (Categorical) | Loss of Control eating will be assessed by interview and self-report and the primary outcome is frequency. Frequency is defined categorically (presence or absence of loss of control eating). | Post-treatment (at 3 months) |
| Loss of Control Eating Frequency (Categorical) | Loss of Control eating will be assessed by interview and self-report and the primary outcome is frequency. Frequency is defined categorically (presence or absence of loss of control eating). | 24 month follow-up (an average of 24 months following treatment) |
| Loss of Control Eating Frequency (Continuous) | Loss of Control eating will be assessed by interview and self-report and the primary outcome is frequency. Frequency also is defined continuously (analyzed dimensionally). | Post-treatment (at 3 months) |
| Loss of Control Eating Frequency (Continuous) | Loss of Control eating will be assessed by interview and self-report and the primary outcome is frequency. Frequency also is defined continuously (analyzed dimensionally). | 24 month follow-up (an average of 24 months following treatment) |
| Body Mass Index (BMI) | BMI is calculated using measured height and weight. | Post-treatment (at 3 months) |
| Body Mass Index (BMI) | BMI is calculated using measured height and weight. | 24 month follow-up (an average of 24 months following treatment) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Carlos M Grilo, Ph.D. | Yale University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Yale Department of Psychiatry | New Haven | Connecticut | 06510 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31197602 | Derived | Lawson JL, Wiedemann AA, Carr MM, Ivezaj V, Duffy AJ, Grilo CM. Examining Sleep Quality Following Sleeve Gastrectomy Among Patients with Loss-of-Control Eating. Obes Surg. 2019 Oct;29(10):3264-3270. doi: 10.1007/s11695-019-03981-7. |
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| ID | Term |
|---|---|
| D009765 | Obesity |
| D009767 | Obesity, Morbid |
| D002032 | Bulimia |
| D056912 | Binge-Eating Disorder |
| D006963 | Hyperphagia |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D059039 | Standard of Care |
| D015928 | Cognitive Behavioral Therapy |
| ID | Term |
|---|---|
| D019984 | Quality Indicators, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |
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| Behavioral Weight Loss Treatment | Behavioral | Biweekly individual guided self-help sessions for 3 months |
|
| Cognitive Behavioral Therapy | Behavioral | Biweekly individual guided self-help sessions for 3 months |
|
| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012817 | Signs and Symptoms, Digestive |
| D001068 | Feeding and Eating Disorders |
| D001523 | Mental Disorders |
| D001521 | Behavior Therapy |
| D011613 | Psychotherapy |
| D004191 | Behavioral Disciplines and Activities |