- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT01626807
Evaluation of a Walking School Bus Program
Evaluation of a Walking School Bus Program: A Cluster Randomized Controlled Trial
Just two generations ago, walking or bicycling to school was the norm for a substantial number of US children, e.g. 48% of children walked or biked to school in 1969 versus only 13% in 2009. This decline occurred in the same timeframe as the childhood obesity epidemic, which is at record high levels in the US and affects low-income and ethnic minority children the most. This project will test "the walking school bus" (WSB) program, in which children walk to and from school with adults, and its impact on low-income, ethnic minority children's walking to school, physical activity, and risk for obesity. Ultimately, this line of research has the potential to provide a low-cost, easy to disseminate program to reduce risk of obesity and cancer for at-risk children.
The investigators Specific Aims among 3rd-5th grade children include:
SA1) To recruit 770 child-parent dyads from 22 elementary schools over 4 years and conduct a cluster randomized controlled trial to assess the efficacy of a WSB program on children's walking to school, physical activity, and BMI z-score over a school-year SA2) To collect and analyze data on individual-, school-, and macro-level influences on changes to children's walking to school resulting from the WSB program
The Primary Hypotheses to be tested, in comparison to control children, include:
H1) The WSB program will increase children's walking to school over a school-year.
H1a) Parents' outcome expectations and self-efficacy will mediate the relationship between the WSB and changes to children's walking to school.
H1b) Walkability, safety, and acculturation will moderate changes to children's walking to school.
H2) The WSB program will increase children's physical activity and decrease BMI z-scores over a school-year.
H3) The WSB program will increase school-level pedestrian safety behaviors over a school-year.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Tipo de estudio
Inscripción (Actual)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
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Washington
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Seattle, Washington, Estados Unidos, 98145-5005
- Seattle Children's Research Institute
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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:
- physically capable of walking to and from school
- live within 1-mile of school or parents agree to regularly drop off children within 1-mile of school
- attend a study school and enrolled in 3rd, 4th, or 5th grade
Exclusion Criteria:
- another child from the same household is enrolled in the study
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Prevención
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Único
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Sin intervención: Cuidado usual
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Experimental: Walking school bus
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Children will have the option of walking to and/or from school with study staff who are trained in Safe Routes to School methods.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Periodo de tiempo |
|---|---|
|
Weekly rate of children's active commuting to school
Periodo de tiempo: 5-6 months
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5-6 months
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Medidas de resultado secundarias
Medida de resultado |
Periodo de tiempo |
|---|---|
|
Moderate-to-vigorous physical activity
Periodo de tiempo: 5-6 months
|
5-6 months
|
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Body mass index z-score
Periodo de tiempo: 5-6 months
|
5-6 months
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Jason A Mendoza, MD, MPH, Seattle Children's Research Institute
Publicaciones y enlaces útiles
Enlaces Útiles
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Estimar)
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
Otros números de identificación del estudio
- 1R01CA163146-01A1 (Subvención/contrato del NIH de EE. UU.)
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .