- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT07583459
Efficacy of Center-based Childcare to Mitigate Unhealthy Weight Gain in Preschoolers From Low-income Households During the Summer
10 de junio de 2026 actualizado por: Michael Beets, University of South Carolina
Studies show that preschool-age children are especially vulnerable to accelerated weight gain during the summer, with those from low-income households (≤185% poverty level or Medicaid eligible - the target population for this study) exhibiting the greatest risk of unhealthy weight gain.
Despite numerous interventions designed to prevent OWOB, none target preschoolers during summer.
For families from low-income households, attending center-based childcare is associated with a lower risk of developing OWOB by 1st grade compared to attending home-based care.
Center-based childcare lowers the risk of OWOB through daily rules/routines that promote healthy behaviors.
For families from low-income households, publicly funded center-based childcares (e.g., needs-based pre-K, Head Start) typically operate on an academic/school 9-month calendar (Aug-May).
During summer, fewer than 30% of preschoolers attend center-based childcare.
For many preschoolers from lower-income households, summer may serve as an extended period away from formal center-based childcare, because the out-of-pocket expense may prohibit attendance.
This may promote unhealthy behaviors and excessive weight gain.
In the majority of US states, publicly funded center-based childcare during the academic/school year for families from underserved populations is free; however, center-based childcare during the summer is an out-of-pocket expense for many of these families.
Despite parents' desire for childcare during the summer, a major reason children from low-income households do not attend center-based care during summer is cost.
This creates unequal access to resources and likely exacerbates health disparities for families from low-income households.
Using a structural intervention approach, this study will test the impact of providing free center-based childcare in the summer.
This R01 will rigorously test the impact of providing free center-based childcare during the summer on weight status of preschoolers from low-income households (≤185% of poverty level or Medicaid eligible).
Descripción general del estudio
Estado
Reclutamiento
Condiciones
Intervención / Tratamiento
Tipo de estudio
Intervencionista
Inscripción (Estimado)
300
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.
Estudio Contacto
- Nombre: Michael W Beets, MEd, MPH, PhD
- Número de teléfono: 8037773003
- Correo electrónico: beets@mailbox.sc.edu
Ubicaciones de estudio
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South Carolina
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Columbia, South Carolina, Estados Unidos, 29208
- Reclutamiento
- University of South Carolina
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Contacto:
- Michael Beets, PhD
- Número de teléfono: 8037773003
- Correo electrónico: beets@mailbox.sc.edu
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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
- Niño
Acepta Voluntarios Saludables
Sí
Descripción
Inclusion Criteria:
- Children will need to be enrolled in a needs-based pre-K program in our partner organizations to be eligible to participate. No other exclusion criteria will be applied
Exclusion Criteria:
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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 paralela
- Enmascaramiento: Doble
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Experimental: Intervention
Children randomly assigned to receive free center-based childcare during the summer will be provided 8 to 10 weeks (depending on the length of summer - which can vary due to school-year closures and make-up days) of access to a school-operated, needs-based center-based childcare during the summer.
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Daily Schedule: The daily schedule will be from ~8am to 5pm M-F.
The centers will provide lunch, snacks, and a nap.
The activities each day will focus on core state curriculum standards for reading, social emotional learning, and kindergarten readiness.
Preschoolers will be offered 2-3 15-20min recess periods each day and be provided physical education for 45min on a rotating 2/3 schedule every 2 weeks (i.e., 2 days/week followed by 3 days/week).
Meals: All meals provided will be reimbursed through the district's Summer Food Service Program and will adhere to the nutritional guidelines of the Summer Food Service Program.
The program will be overseen by district personnel who are responsible for pre-K during the 9m school year.
Staffing: The program will be staffed by pre-K teachers who teach in the district.
Teachers have already expressed interest in staffing the summer program and will be recruited by organization personnel.
Setting: The center-based childcare wil
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Sin intervención: Control
The control group will not receive free access to attend the center-based childcare during the summer.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Bioelectrical Impedance
Periodo de tiempo: Baseline (0 months) prior to the beginning of summer and post intervention at the end of summer (3 months)
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Bioelectrical Impedance (BIA) will be used as a measure of children's body composition.
This will allow for the quantification of whole-body fat mass and fat free mass associated with changes over school and summer.
BIA will be collected via the Inbody 270 (Seoul, South Korea), which is validated for use in 3-4 yr-old children.
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Baseline (0 months) prior to the beginning of summer and post intervention at the end of summer (3 months)
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BMI z-score
Periodo de tiempo: Baseline (0 months) prior to the beginning of summer and post intervention at the end of summer (3 months)
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BMI z-score is a age-sex standardized metric of BMI (height and weight)
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Baseline (0 months) prior to the beginning of summer and post intervention at the end of summer (3 months)
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
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)
1 de mayo de 2026
Finalización primaria (Estimado)
30 de junio de 2030
Finalización del estudio (Estimado)
30 de junio de 2030
Fechas de registro del estudio
Enviado por primera vez
29 de abril de 2026
Primero enviado que cumplió con los criterios de control de calidad
6 de mayo de 2026
Publicado por primera vez (Actual)
13 de mayo de 2026
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
11 de junio de 2026
Última actualización enviada que cumplió con los criterios de control de calidad
10 de junio de 2026
Última verificación
1 de junio de 2026
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- USouthCarolina
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. .