Familial Overweight: Comparing Use of Strategies (FOCUS)
19 de mayo de 2015 actualizado por: Brian Saelens, Seattle Children's Hospital
Behavioral Skill Adherence in Pediatric Obesity Treatment
The purpose of this study is to compare the efficacy of two different approaches (prescribed & self-directed) to the treatment of childhood obesity and their relative impact on child weight status, physical activity, and diet.
Descripción general del estudio
Descripción detallada
Pediatric obesity is a highly prevalent problem, requiring both treatment and prevention efforts to reduce cardiovascular disease risk and metabolic consequences among affected children and the child population.
The efficacy of family-based behavioral pediatric obesity treatment is likely compromised by non-optimal parent and child behavioral skills use (BSU).
In pediatric obesity treatment trials, BSU assessment is infrequent, incomplete, and has unknown reliability.
Poor and incomplete BSU measurement precludes improving behavioral interventions for pediatric obesity.
Furthermore, different approaches to help families initiate and sustain BSU during and following treatment have not been tested.
This study aims to investigate 1) prospective relations between BSU measured during and following treatment and change in child weight status, physical activity, and diet, and 2) differences in BSU trajectory between two different implementation approaches during and following treatment.
Eighty-two parent-child (7-11 y.o.) pairs will participate in a 20-week treatment with follow-up at 3 and 6 months.
Participants will be randomly assigned to receive either a prescriptive or self-directed implementation approach to family-based behavioral pediatric obesity treatment.
BSU (monitoring, contingency management, environmental control) will be reported or assessed at pre-treatment, at the 5th, 10th, and 15th treatment sessions, at post-treatment and at the 3-month and 6-month follow-ups by the parent, interventionist, and supplemental evaluator.
Prospective associations between BSU, measured multiple times and by multiple informant/formats, and change in child weight status (z-BMI) and weight-related behaviors (diet, physical activity) over the course of treatment and throughout follow up will be examined.
This proposal will provide important information about the type of BSU and its measurement that is most related to short- and long-term treatment efficacy, and provide pilot data on the relative efficacy of different implementation approaches to initiate and sustain BSU in pediatric obesity intervention.
Tipo de estudio
Intervencionista
Inscripción (Actual)
72
Fase
- No aplica
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Ubicaciones de estudio
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Washington
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Seattle, Washington, Estados Unidos, 98101
- Seattle Children's Hospital Research Institute
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Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
7 años a 11 años (Niño)
Acepta Voluntarios Saludables
Sí
Géneros elegibles para el estudio
Todos
Descripción
Inclusion Criteria:
- Child age: 7-11 years.
- English-speaking.
- Parent is willing and able to actively participate in treatment.
- Overweight child: at or above 85th percentile for age- and gender-specific BMI, but not more than 175% above median BMI for age and gender.
- Overweight parent: BMI≥ 25.
- Live within 50 miles of Children's Hospital and Regional Medical Center.
Exclusion Criteria:
- Medical condition known to promote obesity (e.g. Prader-Willi syndrome, Cushing's syndrome).
- Already involved with another weight control program.
- Consistently engaging in weight-affecting behaviors (e.g. child: smoking)
- Significant diagnosed obesity-related co-morbidities (e.g. Type 2 diabetes)
- Taking weight-affecting medications (e.g. Ritalin)
- Participating parent or child: an existing thought disorder, suicidality, substance abuse disorder, or other psychological or medical conditions that may preclude full participation.
- Participating parent or child: Disability or illness that would preclude them from engaging in at least moderate intensity physical activity.
- Participating parent or child: Current or prior diagnosed eating disturbance.
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿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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Comparador activo: Prescribed Skills
Behavioral skills are all prescribed and considered necessary tools expected to be used consistently, completely, and uniformly by all participants throughout treatment
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Treatment will be delivered over a 20-week period.
Participating children and at least one of their parents will attend weekly in-person clinic sessions.
Treatment will consist of 20-25 minute meetings between the assigned interventionist and each child/parent pair to individualize treatment, with an emphasis on helping the family change eating and activity behaviors.
Family meetings will be followed by separate child and parent group meetings lasting approximately 35-45 minutes.
In both approaches, parents serve as primary implementers of the treatment for the child and, if overweight, for themselves.
Group sessions provide education in diet and physical activity, parenting, and behavioral skills, although conditions differ in whether skills are "prescribed" or "self-directed".
Children and parents will be weighed at each clinic visit.
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Experimental: Self-Directed Skills
Behavioral skills are considered a tool box from which families are encouraged to select skills that best apply to that family's situation in attempts to help their child make eating and activity change.
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Treatment will be delivered over a 20-week period.
Participating children and at least one of their parents will attend weekly in-person clinic sessions.
Treatment will consist of 20-25 minute meetings between the assigned interventionist and each child/parent pair to individualize treatment, with an emphasis on helping the family change eating and activity behaviors.
Family meetings will be followed by separate child and parent group meetings lasting approximately 35-45 minutes.
In both approaches, parents serve as primary implementers of the treatment for the child and, if overweight, for themselves.
Group sessions provide education in diet and physical activity, parenting, and behavioral skills, although conditions differ in whether skills are "prescribed" or "self-directed".
Children and parents will be weighed at each clinic visit.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Periodo de tiempo |
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Child weight status, physical activity, & diet.
Periodo de tiempo: 6 Months
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6 Months
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Medidas de resultado secundarias
Medida de resultado |
Periodo de tiempo |
|---|---|
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Secondary outcomes will include parents' BMI, and parents' physical activity and eating behaviors and covariates will include child age, gender, and household income.
Periodo de tiempo: 6 Months
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6 Months
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Investigadores
- Investigador principal: Brian E Saelens, PhD, Seattle Children's Hospital Research Institute
Publicaciones y enlaces útiles
La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio
1 de mayo de 2008
Finalización primaria (Actual)
1 de diciembre de 2012
Finalización del estudio (Actual)
1 de diciembre de 2012
Fechas de registro del estudio
Enviado por primera vez
3 de septiembre de 2008
Primero enviado que cumplió con los criterios de control de calidad
3 de septiembre de 2008
Publicado por primera vez (Estimar)
4 de septiembre de 2008
Actualizaciones de registros de estudio
Última actualización publicada (Estimar)
21 de mayo de 2015
Última actualización enviada que cumplió con los criterios de control de calidad
19 de mayo de 2015
Última verificación
1 de mayo de 2015
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- HD54871 (completed)
- 1R21DK095676 (Subvención/contrato del NIH de EE. UU.)
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