- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT02222766
Parents and Tots Together: A Family-Based Obesity Prevention Intervention (PTT)
Parents and Tots Together: A Family-Based Intervention to Promote Healthy Eating and Activity Behaviors Among Preschool Children
The obesity epidemic has spared no age group, including our youngest children. My and others' formative research shows that ethnically-diverse, low-income parents of young children are enthusiastic about learning general parenting skills, such as discipline strategies, but less interested in nutrition and physical activity. To capitalize on this enthusiasm, I will create and test an intervention that embeds strategies to improve child weight-related behaviors within a general skills parenting program.
The overall goal of this study is to assess Parents and Tots Together (PTT), a family-based intervention to prevent obesity among children age 2 through 5 years. To achieve this goal, my colleagues and I will conduct a randomized controlled trial (RCT) among ethnically diverse, primarily low-income families. Our specific aims are to:
- Determine the extent to which the intervention, compared with a control condition, results in a smaller age-associated increase in body mass index (BMI) among children after a 3- month intervention and a 9-month follow-up period (primary outcome).
Determine the extent to which the intervention, compared with a control condition, results in:
- Improved parent general parenting behaviors, i.e., increased use of positive discipline strategies.
- Improved parent feeding practices, i.e., increased responsiveness to child satiety cues.
- Improved child weight-related behaviors, i.e., increased sleep duration and physical activity, and reduced sugar-sweetened beverage intake and television/video viewing.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Tipo de estudio
Inscripción (Actual)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
-
-
Massachusetts
-
Boston, Massachusetts, Estados Unidos, 02215
- Harvard Pilgrim Health Care
-
-
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
- parents who have a child aged 2-5 years
- respond to interviews and questionnaires in English or Spanish
Exclusion Criteria:
- any families who plan to move during the study period
- children or parents with severe health conditions that would prohibit them from participating in study activities
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Prevención
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación de un solo grupo
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
---|---|
Experimental: Parents and Tots Together Program
9-week group-based parenting program
|
Group-based parenting program, 9 sessions offered weekly
|
Comparador activo: Control
Minimal attention control- weekly mailed information on general child development for 9 weeks
|
Minimal attention control- 9 weekly mailed information on general child development
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Periodo de tiempo |
---|---|
Change in body mass index (BMI), adjusted for age and gender
Periodo de tiempo: baseline, post-intervention, 9-month follow-up
|
baseline, post-intervention, 9-month follow-up
|
Medidas de resultado secundarias
Medida de resultado |
Periodo de tiempo |
---|---|
Change in parent general parenting behaviors, i.e., use of positive discipline strategies.
Periodo de tiempo: baseline, post-intervention, 9-month follow-up
|
baseline, post-intervention, 9-month follow-up
|
Change in child weight-related behaviors, i.e., sleep duration and physical activity, and sugar-sweetened beverage intake and television/video viewing.
Periodo de tiempo: baseline, post-intervention, 9-month follow-up
|
baseline, post-intervention, 9-month follow-up
|
Change in parental feeding behaviors, i.e., controlling feeding practices
Periodo de tiempo: baseline, post-intervention, 9-month follow-up
|
baseline, post-intervention, 9-month follow-up
|
Colaboradores e Investigadores
Patrocinador
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 (Estimar)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 190331-41
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. .