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| ID | Type | Description | Link |
|---|---|---|---|
| K23DK115893 | 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 study will develop and test a cognitive-behavioral intervention for adolescents with binge/loss-of-control eating.
Youth who engage in binge eating or loss-of-control eating are at high risk for physical and mental health impairment, as well as excess weight gain. As there are few evidence-based treatments for adolescents with binge/loss-of-control eating, assessment and treatment have received minimal attention for adolescent patients. Among adults, cognitive-behavioral therapy (CBT) has a strong evidence base for binge-eating disorder. Adolescents have unique social, cognitive and emotional needs because of their developmental stage; unique treatment approaches are essential to meet these unique needs. This study will develop a new CBT treatment for adolescents with binge eating or loss-of-control eating (modifying adult CBT for binge-eating disorder, conducting interviews with adolescents about aspects of treatment that need to be modified, conducting an open series of patients who receive the active treatment). This study will also test the efficacy of the newly-developed CBT for adolescents with binge/loss-of-control eating versus a control group in a randomized controlled trial.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cognitive-Behavioral Therapy | Experimental | Adapted Cognitive-Behavioral Therapy (CBT) for adolescents with binge eating or loss-of-control eating. |
|
| Control Condition | Other | Educational materials related to adolescent health and nutrition. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cognitive-Behavioral Therapy for Adolescent Binge/Loss-of-Control Eating | Behavioral | Cognitive-behavioral therapy (CBT) developed for adolescents with binge eating or loss-of-control eating. |
| Measure | Description | Time Frame |
|---|---|---|
| Binge (Loss-of-control) Eating Episode Frequency | Eating episodes will be assessed by questionnaire (Eating Disorder Examination questionnaire) | Post (4 months) |
| Weight (e.g., Percent Loss) | Percent BMI change | Post (4 months) |
| Measure | Description | Time Frame |
|---|---|---|
| Binge (Loss-of-control) Eating Episode Frequency | Eating episodes will be assessed by questionnaire (Eating Disorder Examination Questionnaire) | Short-Term Follow-Up (3 months after end of treatment) |
| Weight (e.g., Percent Loss) |
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Inclusion Criteria: To be included, adolescents must:
Exclusion Criteria: Prospective participants will be excluded if the adolescent:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Yale School of Medicine | New Haven | Connecticut | 06520 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Cognitive-Behavioral Therapy | Adapted Cognitive-Behavioral Therapy (CBT) for adolescents with binge eating or loss-of-control eating. Cognitive-Behavioral Therapy for Adolescent Binge/Loss-of-Control Eating: Cognitive-behavioral therapy (CBT) developed for adolescents with binge eating or loss-of-control eating. |
| FG001 | Control Condition | Educational materials related to adolescent health and nutrition. Control Condition: Educational and informational materials on adolescent health and nutrition. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Cognitive-Behavioral Therapy | Adapted Cognitive-Behavioral Therapy (CBT) for adolescents with binge eating or loss-of-control eating. Cognitive-Behavioral Therapy for Adolescent Binge/Loss-of-Control Eating: Cognitive-behavioral therapy (CBT) developed for adolescents with binge eating or loss-of-control eating. |
| 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 | Binge (Loss-of-control) Eating Episode Frequency | Eating episodes will be assessed by questionnaire (Eating Disorder Examination questionnaire) | Posted | Mean | Standard Deviation | episodes of behavior | Post (4 months) |
|
7 months
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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 | Cognitive-Behavioral Therapy | Adapted Cognitive-Behavioral Therapy (CBT) for adolescents with binge eating or loss-of-control eating. Cognitive-Behavioral Therapy for Adolescent Binge/Loss-of-Control Eating: Cognitive-behavioral therapy (CBT) developed for adolescents with binge eating or loss-of-control eating. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr Janet Lydecker | Yale University | 2037374299 | janet.lydecker@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 | Mar 13, 2024 | Aug 22, 2024 | Prot_SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Mar 7, 2022 | Feb 13, 2024 | ICF_000.pdf |
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| ID | Term |
|---|---|
| D002032 | Bulimia |
| D050177 | Overweight |
| D009765 | Obesity |
| ID | Term |
|---|---|
| D006963 | Hyperphagia |
| D012817 | Signs and Symptoms, Digestive |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D015928 | Cognitive Behavioral Therapy |
| ID | Term |
|---|---|
| D001521 | Behavior Therapy |
| D011613 | Psychotherapy |
| D004191 | Behavioral Disciplines and Activities |
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| Control Condition | Other | Educational and informational materials on adolescent health and nutrition. |
|
Percent BMI change
| Short-Term Follow-Up (3 months after end of treatment) |
| Control Condition |
Educational materials related to adolescent health and nutrition. Control Condition: Educational and informational materials on adolescent health and nutrition. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex/Gender, Customized | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| Binge Eating Episodes | Mean | Standard Deviation | episodes of behavior |
|
|
|
|
| Primary | Weight (e.g., Percent Loss) | Percent BMI change | Posted | Mean | Standard Deviation | percentage of baseline BMI | Post (4 months) |
|
|
|
|
| Secondary | Binge (Loss-of-control) Eating Episode Frequency | Eating episodes will be assessed by questionnaire (Eating Disorder Examination Questionnaire) | Posted | Mean | Standard Deviation | episodes of behavior | Short-Term Follow-Up (3 months after end of treatment) |
|
|
|
|
| Secondary | Weight (e.g., Percent Loss) | Percent BMI change | Posted | Mean | Standard Deviation | percentage of baseline BMI | Short-Term Follow-Up (3 months after end of treatment) |
|
|
|
| 0 |
| 25 |
| 0 |
| 25 |
| 0 |
| 25 |
| EG001 | Control Condition | Educational materials related to adolescent health and nutrition. Control Condition: Educational and informational materials on adolescent health and nutrition. | 0 | 25 | 0 | 25 | 0 | 25 |
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| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |