Building Blocks for Healthy Preschoolers
5 de mayo de 2021 actualizado por: Maureen Black, University of Maryland, Baltimore
Building Blocks for Healthy Preschoolers: Child Care and Family Models
Pediatric obesity, a defining health problem of the century, leads to long-term health disparities. This application evaluates strategies to prevent health disparities early in life by developing environmental wellness-related interventions focused on child-care center staff and families.
Childcare centers provide an excellent opportunity to build healthy dietary and physical activity lifestyle habits and avoid the rapid weight gain that leads to health disparities. Building on a statewide survey among childcare centers and a pilot evaluation of an environmental intervention, this 3-cell randomized trial evaluates the impact of a staff-led wellness intervention and a staff-led and family-focused intervention, against a control condition.
Descripción general del estudio
Estado
Terminado
Condiciones
Intervención / Tratamiento
Descripción detallada
The intervention trial will be conducted in 48-55 childcare centers throughout Maryland, enrolling 864 children age 30-54 months from childcare centers serving low-income families. The aims are:
- to examine the impact of the wellness intervention individually and combined with the family intervention versus control on BMI z-score, food preferences and knowledge, and physical activity among children
- to examine the sustainability of the interventions
- to examine whether changes in outcomes measures for children's BMI z-score, gross motor skills, food preferences and knowledge, and physical activity are mediated by changes in the childcare staff wellness-related attitudes and behaviors and/or parent wellness-related attitudes and behaviors (exploratory).
Findings from the trial will inform programs and policies in childcare centers to prevent obesity and reduce disparities, and will be disseminated locally, regionally, and nationally through conferences, information briefs, social media, and peer-reviewed journal articles. The overall objective is to promote statewide strategies that reduce pediatric obesity and the long-term health disparities.
Tipo de estudio
Intervencionista
Inscripción (Actual)
1943
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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Maryland
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Baltimore, Maryland, Estados Unidos, 21201
- University of Maryland Growth and Nutrition Division
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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
18 años y mayores (Adulto, Adulto Mayor)
Acepta Voluntarios Saludables
Sí
Géneros elegibles para el estudio
Todos
Descripción
Inclusion Criteria:
- Preschooler 30-54 months
- Caregiver and childcare staff must be at least 18 years old
- Childcare center staff members willing to participate
- Licensed childcare centers serving low-income communities
- Children attending participating childcare centers (at least 3 days per week)
Exclusion Criteria:
- Caregivers and staff who do not speak or read English
- Childcare staff and preschoolers with health problems that would interfere with participation in physical activities
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: Prevención
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación factorial
- Enmascaramiento: Único
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Experimental: CHAMP group
Childcare centers randomly assigned the CHAMP group will receive an intervention that promotes physical activity in the classroom by developing gross motor skills through movement and enhances the nutritional environment in the centers by exposing preschoolers to new foods.
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The CHAMP only group intervention is based on "Food Friends & Mighty Moves", a nutritional program designed to introduce new foods over the course of 12 weeks to preschoolers to create positive eating experiences.
In conjunction with the nutritional program, the intervention also consists of an 18 week physical activity program designed to develop gross motor skills.
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Experimental: CHAMP+ group
These childcare centers, also randomly assigned, will have the same intervention as the CHAMP group in addition to a parenting intervention that promotes wellness and healthy behaviors within families.
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The CHAMP only group intervention is based on "Food Friends & Mighty Moves", a nutritional program designed to introduce new foods over the course of 12 weeks to preschoolers to create positive eating experiences.
In conjunction with the nutritional program, the intervention also consists of an 18 week physical activity program designed to develop gross motor skills.
The CHAMP+ component is comprised of a curriculum of parenting, wellness, physical activity, and feeding in the home environment.
The CHAMP+ intervention will span over the course of the CHAMP intervention.
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Sin intervención: Control
This group will not receive theCHAMP intervention at the childcare center nor will this group receive the CHAMP+ parenting intervention.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Change of BMI Z-score for preschoolers
Periodo de tiempo: Baseline to 6 month (Midline) Follow-up or 1 year (Post Intervention) Follow-up
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Measured weight and height for the preschoolers, calculated as age and gender-specific BMI Z-score
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Baseline to 6 month (Midline) Follow-up or 1 year (Post Intervention) Follow-up
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Change of Physical Activity for preschoolers and childcare center staff
Periodo de tiempo: Baseline to 6 month (Midline) Follow-up or 1 year (Post Intervention) Follow-up
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Moderate to Vigorous Physical Activity (MVPA) based on anthropometrics
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Baseline to 6 month (Midline) Follow-up or 1 year (Post Intervention) Follow-up
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Change in Gross Motor Skills
Periodo de tiempo: Baseline to 6 month (Post Intervention) Follow-up or 1 year (Delayed Intervention) Follow-up
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Measured by Test of Gross Motor Development-2
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Baseline to 6 month (Post Intervention) Follow-up or 1 year (Delayed Intervention) Follow-up
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Change in Preschoolers to try new foods
Periodo de tiempo: Baseline to 6 month (Post Intervention) Follow-up or 1 year (Delayed Intervention) Follow-up
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Measured by Food Neophobia Scale (Caregiver report)
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Baseline to 6 month (Post Intervention) Follow-up or 1 year (Delayed Intervention) Follow-up
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Change in Preschoolers to try new foods
Periodo de tiempo: Baseline to 6 month (Post Intervention) Follow-up or 1 year (Delayed Intervention) Follow-up
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Measured by Fruit & Vegetable Knowledge & Preference Test
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Baseline to 6 month (Post Intervention) Follow-up or 1 year (Delayed Intervention) Follow-up
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Change in Preschoolers to try new foods
Periodo de tiempo: Baseline to 6 month (Post Intervention) Follow-up or 1 year (Delayed Intervention) Follow-up
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Measured by Food Tasting Assessment
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Baseline to 6 month (Post Intervention) Follow-up or 1 year (Delayed Intervention) Follow-up
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Investigadores
- Investigador principal: Maureen M Black, PhD, University of Maryland, Baltimore
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
- Rahmaty Z, Johantgen ME, Storr CL, Wang Y, Black MM. Preschoolers BMI: Associations with Patterns of Caregivers' Feeding Practices Using Structural Equation Models. Child Obes. 2022 Jun 1. doi: 10.1089/chi.2022.0026. Online ahead of print.
- Armstrong B, Trude ACB, Johnson C, Castelo RJ, Zemanick A, Haber-Sage S, Arbaiza R, Black MM. CHAMP: A cluster randomized-control trial to prevent obesity in child care centers. Contemp Clin Trials. 2019 Nov;86:105849. doi: 10.1016/j.cct.2019.105849. Epub 2019 Sep 13.
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 (Actual)
17 de junio de 2016
Finalización primaria (Actual)
13 de marzo de 2020
Finalización del estudio (Actual)
13 de marzo de 2020
Fechas de registro del estudio
Enviado por primera vez
27 de marzo de 2017
Primero enviado que cumplió con los criterios de control de calidad
6 de abril de 2017
Publicado por primera vez (Actual)
12 de abril de 2017
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
10 de mayo de 2021
Última actualización enviada que cumplió con los criterios de control de calidad
5 de mayo de 2021
Última verificación
1 de mayo de 2021
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- HP-00065933
- 1R01DK107761-01 (Subvención/contrato del NIH de EE. UU.)
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
NO
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
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. .
Ensayos clínicos sobre CHAMP
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University of TorontoUniversity Health Network, Toronto; Sunnybrook Health Sciences Centre; Unity HealthAún no reclutando
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University Health Network, TorontoReclutamientoCáncer | Adultos mayoresCanadá
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Indiana UniversityNational Institute on Aging (NIA)TerminadoDelirio | Deterioro CognitivoEstados Unidos