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Enhancing Self Regulation as a Strategy for Obesity Prevention in Head Start Preschoolers

18 de julio de 2017 actualizado por: Julie Lumeng, University of Michigan
The goal of this integrated project targeting the Childhood Obesity Prevention Challenge Area is to reduce the prevalence of obesity among children attending Head Start in Michigan. The proposed intervention program is based on Social Cognitive theory and the premise that enhancing children's capacity for emotional and behavioral self-regulation is a key component of effective obesity prevention. A randomized controlled trial design is proposed to evaluate, among 600 Head Start children and their parents, the effectiveness of 2 approaches to obesity prevention: (1) the Parents of Preschoolers Prevention Series (POPS), a curriculum delivered to preschoolers and their parents focused on obesity-related health behaviors; and (2) POPS in combination with the Incredible Years Series (IYS), an evidence-based program designed to improve preschoolers' emotional and behavioral self-regulation. The research objective is to test the hypotheses that: (1) POPS, compared to Usual Head Start exposure, will lead to greater improvements in obesity-related health behaviors and adiposity indices; and (2) POPS + IYS will lead to the greatest improvements in obesity-related health behaviors and adiposity indices, and this effect will be mediated by improved self-regulation. The extension objective is to evaluate the feasibility, fidelity, and educational effectiveness of the POPS and POPS + IYS interventions, as delivered by paraprofessionals and educators within Extension and Head Start. The education objective is to provide Extension and Head Start staff non-formal training and educational curricula which can be widely disseminated. The long-term goal of this project is disseminate a novel and effective approach to obesity prevention in preschoolers.

Descripción general del estudio

Tipo de estudio

Intervencionista

Inscripción (Actual)

697

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

    • Michigan
      • Ann Arbor, Michigan, Estados Unidos, 48109-5406
        • University of Michigan

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

2 años a 6 años (Niño)

Acepta Voluntarios Saludables

Géneros elegibles para el estudio

Todos

Descripción

Inclusion Criteria:

  • child is enrolled in Head Start

Exclusion Criteria:

  • Significant developmental disabilities that would preclude participation
  • Child is a foster child
  • Parent is non-English speaking

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: Ninguno (etiqueta abierta)

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Sin intervención: Usual Head Start Exposure
Children will attend their usual Head Start classroom and receive the usual educational interventions provided in that classroom.
Experimental: Parents of Preschoolers Series (POPS)
Children attend Head Start preschool. Within the classroom, they receive a series of lessons about nutrition and obesity prevention delivered by an Extension Educator in collaboration with the classroom teacher. Parents are invited to attend a series of classes about nutrition and obesity prevention.

The POPS-Parent intervention consists of eight 60-90 minute lessons about preventing childhood obesity followed by four 10-minute reinforcing telephone contacts. Each lesson includes opportunities for parents to develop and practice skills, and a discussion of strategies to overcome challenges and problem-solving techniques, with an emphasis on building knowledge and self-efficacy.

The POPS-Child Intervention uses children's stories with embedded healthy nutrition themes. Five lessons (6 books) are delivered over 12 weeks. Activities include classroom cooking experiences, games/activities associated with the story's nutrition themes, and goal setting. "Family Links" and "Parent Pages" are sent home to reinforce content from school to home.

Experimental: POPS + Incredible Years Series (IYS)
Children attend Head Start preschool. Within the classroom, they receive a series of lessons about nutrition and obesity prevention delivered by an Extension Educator in collaboration with the classroom teacher. Parents are invited to attend a series of classes about nutrition and obesity prevention. In the classroom, children also receive a series of lessons about emotional and behavioral self-regulation delivered by a trained mental health specialist. The parents also are invited to classes about child behavioral and emotional self-regulation delivered by a mental health specialist.

The POPS-Parent intervention consists of eight 60-90 minute lessons about preventing childhood obesity followed by four 10-minute reinforcing telephone contacts. Each lesson includes opportunities for parents to develop and practice skills, and a discussion of strategies to overcome challenges and problem-solving techniques, with an emphasis on building knowledge and self-efficacy.

The POPS-Child Intervention uses children's stories with embedded healthy nutrition themes. Five lessons (6 books) are delivered over 12 weeks. Activities include classroom cooking experiences, games/activities associated with the story's nutrition themes, and goal setting. "Family Links" and "Parent Pages" are sent home to reinforce content from school to home.

The Parent component (BASIC) is a group-based program (12-14 weeks, 2 hours/week) focused on enhancing parenting skills such as using effective praise, incentives, and limit-setting, and handling misbehavior. Parents complete homework activities that will be reviewed in group sessions and receive follow-up reinforcement phone calls.

For the Child component ("Dinosaur School"), 60, 15-20 minute lessons are delivered during "Circle Time" in Head Start classrooms followed by small group activities. The curriculum focuses on teaching self-regulation skills, problem-solving strategies, and prosocial behaviors.

Teachers are trained in classroom management strategies.

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Change in Body Mass Index Z-score
Periodo de tiempo: 9 months
Child BMI z-score was calculated from measure height and weight at enrollment and at the end of the study period
9 months

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Change in Teacher-reported Self-regulation as Measured by the General Adaptation T-score From the Social Competence and Behavior Evaluation Scale
Periodo de tiempo: 9 months
To assess self-regulation, teachers completed a modified 60-item version of the Social Competence and Behavior Evaluation (SCBE) scale.The SCBE assesses emotional and behavioral regulation difficulties typically seen in the preschool setting. It includes both positive (competence) and negative (emotional or behavioral problems) items, including internalizing (ie, anxious, sad) and externalizing (ie, oppositional) behaviors, both of which are indicators of poor behavioral self-regulation. The General Adaptation T-score assesses child overall emotional and behavioral self-regulation in the classroom setting. It is calculated by taking the mean of all 60 items for the SCBE questionnaire (with reverse scoring for questions capturing problem behavior) and then determining the corresponding t-score based on published tables. Higher scores indicate better self-regulation. The range for General Adaptation T-score is 30-70.
9 months

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

Investigadores

  • Investigador principal: Julie Lumeng, MD, University of Michigan

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.

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 marzo de 2011

Finalización primaria (Actual)

1 de mayo de 2015

Finalización del estudio (Actual)

1 de mayo de 2015

Fechas de registro del estudio

Enviado por primera vez

19 de julio de 2011

Primero enviado que cumplió con los criterios de control de calidad

19 de julio de 2011

Publicado por primera vez (Estimar)

20 de julio de 2011

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

5 de febrero de 2018

Última actualización enviada que cumplió con los criterios de control de calidad

18 de julio de 2017

Última verificación

1 de julio de 2017

Más información

Términos relacionados con este estudio

Palabras clave

Otros números de identificación del estudio

  • 2010-04785

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