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临床试验/NCT01697124
NCT01697124已完成不适用

The Children in Action Feasibility Study

Baylor College of Medicine0 个研究点目标入组 274 人开始时间: 2007年9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
274
主要终点
Change from baseline in physical activity at post-intervention.

研究概览

简要总结

The Children in Action (CIA) program was a five month physical activity intervention. This intervention was a feasibility study with 3- to 5-year-olds enrolled in four Head Start centers. After baseline assessment, centers were matched by ethnicity and for number of participants and randomly assigned to either the intervention or the control condition. A total of 224 preschool children were randomly selected across the four centers. To evaluate the efficacy of the CIA intervention, the change in physical activity, gross motor skills and weight during the awake time and used mixed effect time-series regression models was compared. Observations did not show a statistical difference between intervention and control groups in physical activity level during the awake time, gross motor development or weight status. It was demonstrated that it is feasible to conduct the SPARK-EC curriculum among preschool children attending Head Start Centers but that an increased dose and/or longer intervention duration will be required to impact gross motor skills, weight status and physical activity levels during this critical early childhood development stage.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Prevention
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
3 Years 至 5 Years(Child)
性别
All
接受健康志愿者
是

入选标准

  • •3-5 years old
  • •attends Head Start
  • •African-American
  • •Hispanic-American

排除标准

  • •older than 5 years old
  • •does not attend Head Start
  • •race/ethnicity other than African-American or Hispanic-American
  • •has a disability or handicap that would prevent them from participating in physical activities

研究组 & 干预措施

SPARK-EC

Experimental

SPARK-EC curriculum for preschoolers offered instruction and practice in a comprehensive program designed to promote motor development through increased physical activity.

干预措施: SPARK-EC (Behavioral)

结局指标

主要结局

Change from baseline in physical activity at post-intervention.

时间窗: 8 months

Mini-Mitter Actical, an accelerometer-based activity monitor, was used to assess physical activity of the preschool children. Unit of measurement was mean percentage of time spent in sedentary, light and moderate-vigorous physical activity each day.

次要结局

  • Change from baseline in gross motor skills at post intervention.(8 months)
  • Body Mass Index(8 months)

研究者

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

Theresa A Nicklas

Professor of Pediatrics

Baylor College of Medicine

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