Cognitive and Behavioral Approaches to Reduce Binge Eating and Excess Weight in Adolescents (Online) (CARE2)
Cognitive and Behavioral Approaches to Reduce Binge Eating and Excess Weight in Adolescents (CARE2)
This study will compare a psychological treatment (cognitive-behavioral therapy; CBT-BED) and a lifestyle beahvioral obesity intervention (LBOI) for adolescents who experience binge eating and have overweight or obesity. These treatments will be compared to each other and to a control condition that involves self-monitoring eating and mood using an "app". Participants can be located in most states in the United States. All participation occurs remotely by telehealth. The goal is to learn which approach works best for reducing binge eating and excess weight in this age group.
Descripción general del estudio
Estado
Descripción detallada
Binge eating is the most prevalent eating disorder but has the lowest rate (<4%) of receiving eating disorder treatment. Binge eating often begins in adolescence and is related to obesity, physical and mental health problems, and psychological distress. Yet, there are virtually no established treatments, and no clear standard of care, for adolescents with binge eating. Evidence-based treatments exist for adults, including psychological treatments (e.g., CBT-BED) and lifestyle behavioral obesity intervention (LBOI), but how well these treatments work for adolescents remains largely unknown. LBOI is an effective treatment for adolescent obesity, but has only been tested as additional outcomes (not the initial goal) for binge eating. There is an urgent need for research to establish the efficacy of interventions for adolescents with binge eating to improve adolescents' health and quality of life. This study will conduct a randomized controlled trial (RCT) in which adolescents are randomized to Psychological Treatment (cognitive behavioral therapy for binge eating, or CBT-BED), Behavioral Treatment (lifestyle health behavioral treatment for obesity, or LBOI), or Active Control. In this study, we will compare both CBT-BED and LBOI to each other and to an Active Control. Active Control is daily self-monitoring (emotions, eating, exercise) on an "app", mimicking real-world self-help, followed by choice of CBT-BED or LBOI.
Tipo de estudio
Inscripción (Estimado)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
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Indiana
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Indianapolis, Indiana, Estados Unidos, 46202
- Indiana University School of Medicine
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Contacto:
- Janet Lydecker, PhD
- Número de teléfono: 317-963-7288
- Correo electrónico: jalydeck@iu.edu
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
- Be in the age range ≥12 years old and ≤17 years old;
- Have a BMI that places them above the 85th percentile based on their age and sex;
- Report 4 episodes of binge eating (feeling a loss of control while eating) per month for the past 3 months;
- Be available for participation in the study for 18 months.
Exclusion Criteria:
- Have a medical or psychiatric condition that would require a higher level of care, such as hospitalization or intensive outpatient care (e.g., neurological disorder, psychotic disorders, suicidality);
- Have a medical or psychiatric condition that would prohibit them from engaging in behavioral treatment or moderate physical activity (e.g., cardiovascular problems);
- Have uncontrolled medical condition(s) (e.g., uncontrolled diabetes or hypertension);
- Be pregnant or breastfeeding;
- Be taking medication(s) or participating in treatment(s) that could influence weight or appetite;
- Have begun taking hormonal contraceptives less than 3 months prior, as this can be related to weight changes;
- Have a developmental or cognitive disorder that would interfere with engaging in cognitive treatment;
- Have a concurrent feeding/eating disorder (e.g., bulimia nervosa); or
- Be participating in another clinical research study.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Único
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Experimental: Cognitive-Behavioral Therapy
Cognitive-behavioral therapy for binge-eating disorder (CBT-BED) for adolescents with binge eating and overweight or obesity, delivered remotely by telehealth. |
Cognitive-behavioral therapy for binge-eating disorder (CBT-BED) for adolescents with binge eating and overweight or obesity, delivered remotely by telehealth. Sessions target cognitive and emotional drivers of binge eating through coping skills, problem-solving triggers, cognitive restructuring, and executive-function skill training; parent sessions focus on communication and support.
Otros nombres:
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Experimental: Lifestyle Behavioral Obesity Intervention
Lifestyle behavioral obesity intervention (LBOI) for adolescents with binge eating and overweight or obesity, delivered remotely by telehealth. |
Lifestyle behavioral obesity intervention (LBOI) for adolescents with binge eating and overweight or obesity, delivered remotely by telehealth. Sessions provide nutrition and physical-activity prescriptions to create a modest calorie deficit and sustainable lifestyle habits and problem-solve nonadherence; parent sessions focus on the home food environment.
Otros nombres:
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Comparador activo: Active Control
Active control: daily self-monitoring of eating, emotions, and physical activity via an "app," similar to real-world digital self-help. At the end of the initial period, individuals are presented with descriptions of CBT-BED and LBOI, choose their preferred treatment, and receive it. |
Self-monitoring eating, emotions, and exercise daily in a digital "app" that is similar to real-world self-help.
Otros nombres:
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Binge Eating Episode Frequency
Periodo de tiempo: End of treatment (6 months)
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Eating episodes will be assessed by the Eating Disorder Examination |
End of treatment (6 months)
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Weight (e.g., Percent Loss)
Periodo de tiempo: End of treatment (6 months)
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Percent body mass index change |
End of treatment (6 months)
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Eating Disorder Severity
Periodo de tiempo: End of treatment (6 months)
|
Global eating-disorder psychopathology will be assessed by the Eating Disorder Examination (scores range from 0 through 6; higher scores indicate more severe psychopathology). |
End of treatment (6 months)
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Weight-related Quality of Life score
Periodo de tiempo: End of treatment (6 months)
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Weight-related quality of life will be assessed by questionnaire. |
End of treatment (6 months)
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Colaboradores e Investigadores
Patrocinador
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Estimado)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
- Desordenes mentales
- Trastornos Nutricionales
- Sobrenutrición
- Peso corporal
- Hiperfagia
- Signos y Síntomas Digestivos
- Condiciones Patológicas, Signos y Síntomas
- Enfermedades Nutricionales y Metabólicas
- Signos y síntomas
- Exceso de peso
- Bulimia
- Obesidad
- Trastornos de la alimentación y la alimentación
- Técnicas de investigación
- Terapéutica
- Técnicas de laboratorio clínico
- Técnicas y procedimientos de diagnóstico
- Diagnóstico
- Terapia conductual
- Psicoterapia
- Disciplinas y actividades de comportamiento
- Análisis de químicos de sangre
- Pruebas de química clínica
- Técnicas de diagnóstico, endocrino
- Monitoreo, fisiológico
- Autoestimidad
- Cuidados personales
- Terapia cognitiva conductual
- Auto-monitoreo de glucosa en sangre
Otros números de identificación del estudio
- 32948
- R01DK146817 (Subvención/contrato del NIH de EE. UU.)
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Descripción del plan IPD
de-identified data will be shared with qualified researchers with ethics board approval and a data use agreement.
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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