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This study will perform a clinical trial with adolescents to pilot a new cognitive-behavioral treatment (CBT) for weight-related bullying testing (1) feasibility, (2) acceptability, and (3) initial efficacy. The treatment will be conducted via audio/video telehealth.
Youth with obesity are more likely to be bullied than healthy-weight peers and weight-related bullying is the most common form of bullying. Treating bullying during childhood could reduce immediate and long-term health consequences, but there are no established individual-level treatments for weight-related bullying despite recommendations that they could improve children's health. This study will develop and test a new treatment for adolescents (11-17 years old) who have experienced bullying due to weight. The treatment will address traumatic stress and potentially co-occurring or developing problems with unhealthy weight-control behaviors, disordered eating, and weight. The treatment will be conducted via audio/video telehealth to increase accessibility and is therefore available to anyone in the United States who meets eligibility criteria.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CBT for Weight Bullying | Experimental | Cognitive-Behavioral Therapy (CBT) for children who have experienced weight-related bullying |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CBT for Weight Bullying | Behavioral | Cognitive-behavioral therapy for weight-related bullying delivered by audio/video telehealth. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Stress | Reductions in traumatic stress as measured by the Children's Revised Impact of Event Scale (total; scores range from 0 to 65 with higher scores indicative of more traumatic stress) | post (3 months) |
| Measure | Description | Time Frame |
|---|---|---|
| Body Dissatisfaction | Reductions in body dissatisfaction (weight and shape dissatisfaction) as measured by the brief Eating Disorder Examination Questionnaire (scores range from 0 to 6; higher scores are indicative of more concern) | post (3 months) |
| Overvaluation |
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Inclusion Criteria: To be included, adolescents must:
Exclusion Criteria: Prospective participants will be excluded if the adolescent:
Identifying as female
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| Name | Affiliation | Role |
|---|---|---|
| Janet A Lydecker, PhD | Yale University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Yale University School of Medicine | New Haven | Connecticut | 06519 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39007703 | Derived | Lydecker JA, Ozbardakci EV, Lou R, Grilo CM. Trauma-Focused Cognitive-Behavioral Therapy for Adolescents Bullied Because of Weight: A Feasibility Study. Int J Eat Disord. 2024 Oct;57(10):2117-2127. doi: 10.1002/eat.24257. Epub 2024 Jul 15. |
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| ID | Title | Description |
|---|---|---|
| FG000 | CBT for Weight Bullying | Cognitive-Behavioral Therapy (CBT) for children who have experienced weight-related bullying CBT for Weight Bullying: Cognitive-behavioral therapy for weight-related bullying delivered by audio/video telehealth. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | CBT for Weight Bullying | Cognitive-Behavioral Therapy (CBT) for children who have experienced weight-related bullying CBT for Weight Bullying: Cognitive-behavioral therapy for weight-related bullying delivered by audio/video telehealth. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 | Stress | Reductions in traumatic stress as measured by the Children's Revised Impact of Event Scale (total; scores range from 0 to 65 with higher scores indicative of more traumatic stress) | Posted | Mean | Standard Deviation | units on a scale | post (3 months) |
|
|
3 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 | CBT for Weight Bullying | Cognitive-Behavioral Therapy (CBT) for children who have experienced weight-related bullying CBT for Weight Bullying: Cognitive-behavioral therapy for weight-related bullying delivered by audio/video telehealth. |
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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 | Jun 25, 2021 | Aug 22, 2024 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jun 25, 2021 | Aug 22, 2024 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D058445 | Bullying |
| D001835 | Body Weight |
| D000067073 | Psychological Trauma |
| D001068 | Feeding and Eating Disorders |
| D009765 | Obesity |
| ID | Term |
|---|---|
| D000374 | Aggression |
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
| D000071277 | Harassment, Non-Sexual |
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Reductions in overvaluation of shape/weight as measured by the brief Eating Disorder Examination Questionnaire (scores range from 0 to 6; higher scores are indicative of more concern) |
| post (3 months) |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Stress | Children's Revised Impact of Event Scale (total score; scores range from 0 to 65 with higher scores indicative of more traumatic stress) | Mean | Standard Deviation | units on a scale |
|
| Body Dissatisfaction | Body dissatisfaction subscale of the brief Eating Disorder Examination Questionnaire (weight dissatisfaction and shape dissatisfaction). | data not available on two participants. | Mean | Standard Deviation | units on a scale |
|
| Overvaluation of Shape/Weight | Overvaluation subscale of the brief Eating Disorder Examination Questionnaire (weight overvaluation and shape overvaluation). | data not available on two participants. | Mean | Standard Deviation | units on a scale |
|
|
|
| Secondary | Body Dissatisfaction | Reductions in body dissatisfaction (weight and shape dissatisfaction) as measured by the brief Eating Disorder Examination Questionnaire (scores range from 0 to 6; higher scores are indicative of more concern) | Posted | Mean | Standard Deviation | units on a scale | post (3 months) |
|
|
|
|
| Secondary | Overvaluation | Reductions in overvaluation of shape/weight as measured by the brief Eating Disorder Examination Questionnaire (scores range from 0 to 6; higher scores are indicative of more concern) | Posted | Mean | Standard Deviation | units on a scale | post (3 months) |
|
|
|
|
| 0 |
| 28 |
| 0 |
| 28 |
| 0 |
| 28 |
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| D012919 |
| Social Behavior |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D040921 | Stress Disorders, Traumatic |
| D000068099 | Trauma and Stressor Related Disorders |
| D001523 | Mental Disorders |
| D012817 | Signs and Symptoms, Digestive |
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |