- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT02144519
Physical Activity and Nutrition Intervention in Afterschool Programs
12 de noviembre de 2020 actualizado por: Michael Beets, University of South Carolina
Nutrition and Physical Activity Policies, Obesogenic Behaviors and Weight Outcomes
The investigators long-term goal is to advance the adoption and successful implementation of policies that promote PA and nutrition in after school programs (ASP) nationwide.
The investigators objective here is two fold.
First, the investigators will test the effectiveness of two promising strategies designed to 1) increase the amount of PA children accumulate while attending an ASP and 2) promote changes in the nutritional quality of the snacks served.
This represents a fundamental step in establishing practice-based guidelines (best practices) for the uptake and achievement of public health policy goals (CA and Harvard).
Second, the investigators will examine the barriers and facilitators to implementing these strategies.
The expected outcome of this study is evidence supporting best practices for ASPs to employ to meet policy goals.
Descripción general del estudio
Estado
Terminado
Condiciones
Intervención / Tratamiento
Descripción detallada
The investigators will use a 3-year delayed treatment, cluster randomized controlled trial design with 20 ASPs that serve mostly low-income and minority children (approximately 1300 children ages 6-12yrs) in Columbia, SC and address the following specific aims: Aim 1. Evaluate the impact of a staff-level intervention, a professional development training program focused on core competencies to promote physical activity, on children's physical activity levels; Aim 2. Evaluate the impact of a site-level intervention, a snack modification program that includes a discount buying program, on the quality of snacks served and consumed; and Aim 3. Evaluate the implementation of the staff-level and site-level interventions and identify organizational, staff, and setting characteristics that influence the process of implementing these strategies.
Tipo de estudio
Intervencionista
Inscripción (Actual)
2635
Fase
- No aplica
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
6 años a 12 años (Niño)
Acepta Voluntarios Saludables
No
Géneros elegibles para el estudio
Todos
Descripción
Inclusion Criteria:
Programs that:
- Operate immediately after the school day
- Operate every day of the school year for a minimum of 2 hours
- Serve a minimum of 30 children of elementary age (6-12 years)
- Operate in a school, community or faith Setting
- Provide a snack
- Provide homework assistance/completion time
- Provide enrichment
- Provide opportunities for physical activity
- All children enrolled, staff, and afterschool program (ASP) leaders in the ASPs were eligible to participate in the study.
Exclusion Criteria:
- Programs that:
- Were singularly focused
- Programs that were physical activity focused
Children that:
- Have any physical and/or orthopedic impairment that would limit a child's ability to participate in regular physical activity.
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: Otro
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Experimental: Immediate Intervention
Over the 3 year project, this arm receives the Healthy Eating and Physical Activity intervention after year 1 (baseline) for a total of 2 years (year 2 and 3).
|
Create partnerships with ASPs to help facilitate changes in programming to meet the National Afterschool Alliance's HEPA Standards.
Otros nombres:
|
|
Experimental: Delayed Intervention
Over the 3 year project, this arm serves as the no treatment control/comparison group for year 1 and 2 (2 years of baseline) and receives the Healthy Eating and Physical Activity intervention in year 3 for a total of 1 year.
|
Create partnerships with ASPs to help facilitate changes in programming to meet the National Afterschool Alliance's HEPA Standards.
Otros nombres:
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Change in Percentage of Children Meeting Physical Activity Policy
Periodo de tiempo: Spring of Year 1, Year 2, and Year 3
|
We will assess the number of children meeting the physical activity policy of 30 minutes or more of moderate-to-vigorous physical activity.
The primary physical activity (PA) and sedentary behavior outcome was derived via accelerometry.
All children attending an ASP on unannounced measurement days had an opportunity to wear the ActiGraph GT3X+.
The accelerometers were distilled using 5-second epochs.
When children arrived to a program, they were fitted with an accelerometer and the arrival time was recorded (monitor time on).
Before a child departed from a program, research staff removed the belt and recorded the time of departure (monitor time off).
Children wore the monitors for their entire attendance at the ASPs.
Cutpoint thresholds associated with moderate and vigorous activity were used to distill the PA intensity levels and sedentary behavior.
Children were considered to have a valid day of accelerometer data if their total wear time (time off minus time on) was ≥60 minutes.
|
Spring of Year 1, Year 2, and Year 3
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Changes in Nutritional Quality of Snacks
Periodo de tiempo: Spring of Year 1, Year 2, and Year 3
|
We will assess quality of snacks served at the ASPs in terms of number of fruits and vegetables served per week.
These analyses were performed at the ASP level with a sample size of 20 (10 per arm)
|
Spring of Year 1, Year 2, and Year 3
|
Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Investigadores
- Investigador principal: Michael W Beets, PhD, University of South Carolina
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.
Publicaciones Generales
- Beets MW, Weaver RG, Turner-McGrievy G, Huberty J, Ward DS, Pate RR, Freedman D, Hutto B, Moore JB, Bottai M, Chandler J, Brazendale K, Beighle A. Physical activity outcomes in afterschool programs: A group randomized controlled trial. Prev Med. 2016 Sep;90:207-15. doi: 10.1016/j.ypmed.2016.07.002. Epub 2016 Jul 7.
- Beets MW, Weaver RG, Turner-McGrievy G, Huberty J, Ward DS, Freedman D, Hutto B, Moore JB, Beighle A. Making Healthy Eating Policy Practice: A Group Randomized Controlled Trial on Changes in Snack Quality, Costs, and Consumption in After-School Programs. Am J Health Promot. 2016 Sep;30(7):521-31. doi: 10.4278/ajhp.141001-QUAN-486. Epub 2016 Jun 17.
- Beets MW, Weaver RG, Turner-McGrievy G, Huberty J, Ward DS, Pate RR, Freedman D, Hutto B, Moore JB, Beighle A. Making policy practice in afterschool programs: a randomized controlled trial on physical activity changes. Am J Prev Med. 2015 Jun;48(6):694-706. doi: 10.1016/j.amepre.2015.01.012.
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 agosto de 2012
Finalización primaria (Actual)
1 de abril de 2015
Finalización del estudio (Actual)
1 de mayo de 2016
Fechas de registro del estudio
Enviado por primera vez
13 de mayo de 2014
Primero enviado que cumplió con los criterios de control de calidad
21 de mayo de 2014
Publicado por primera vez (Estimar)
22 de mayo de 2014
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
16 de noviembre de 2020
Última actualización enviada que cumplió con los criterios de control de calidad
12 de noviembre de 2020
Última verificación
1 de noviembre de 2020
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 1R01HL112787-01A1 (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. .