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临床试验/NCT01398358
NCT01398358已完成不适用

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

University of Michigan1 个研究点 分布在 1 个国家目标入组 697 人开始时间: 2011年3月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
697
试验地点
1
主要终点
Change in Body Mass Index Z-score

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
None

入排标准

年龄范围
2 Years 至 6 Years(Child)
性别
All
接受健康志愿者
是

入选标准

  • •child is enrolled in Head Start

排除标准

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

研究组 & 干预措施

Usual Head Start Exposure

No Intervention

Children will attend their usual Head Start classroom and receive the usual educational interventions provided in that classroom.

Parents of Preschoolers Series (POPS)

Experimental

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.

干预措施: Parents of Preschoolers Series (Behavioral)

POPS + Incredible Years Series (IYS)

Experimental

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.

干预措施: Parents of Preschoolers Series (Behavioral)

POPS + Incredible Years Series (IYS)

Experimental

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.

干预措施: Incredible Years Series (Behavioral)

结局指标

主要结局

Change in Body Mass Index Z-score

时间窗: 9 months

Child BMI z-score was calculated from measure height and weight at enrollment and at the end of the study period

次要结局

  • Change in Teacher-reported Self-regulation as Measured by the General Adaptation T-score From the Social Competence and Behavior Evaluation Scale(9 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Julie Lumeng

Associate Professor of Pediatrics

University of Michigan

研究点 (1)

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