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The Children in Action Feasibility Study (CIA)

2012年9月28日 更新者:Theresa A Nicklas、Baylor College of Medicine
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.

研究概览

地位

完全的

研究类型

介入性

注册 (实际的)

274

阶段

  • 不适用

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

3年 至 5年 (孩子)

接受健康志愿者

是的

有资格学习的性别

全部

描述

Inclusion Criteria:

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

Exclusion Criteria:

  • 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

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 主要用途:预防
  • 分配:不适用
  • 介入模型:单组作业
  • 屏蔽:单身的

武器和干预

参与者组/臂
干预/治疗
实验性的:SPARK-EC
SPARK-EC curriculum for preschoolers offered instruction and practice in a comprehensive program designed to promote motor development through increased physical activity.
The CIA study was a 5 month physical activity change intervention that utilized the SPARK-EC curriculum as the intervention. The SPARK-EC curriculum was designed to be a quality, comprehensive physical activity program for the preschool setting. Pre-and Post-intervention assessments were conducted

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Change from baseline in physical activity at post-intervention.
大体时间: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.
8 months

次要结果测量

结果测量
措施说明
大体时间
Change from baseline in gross motor skills at post intervention.
大体时间:8 months
Gross motor skills were measured using the Test of Gross Motor Development. Unit of measurement was the Total Gross Motor Development percentile rank.
8 months
Body Mass Index
大体时间:8 months
Body Mass Index was calculated using height and weight measures collected on the preschool children. Unit of measurement was kilograms (wt.)/meters squared (ht.).
8 months

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始

2007年9月1日

初级完成 (实际的)

2009年8月1日

研究完成 (实际的)

2009年8月1日

研究注册日期

首次提交

2012年9月17日

首先提交符合 QC 标准的

2012年9月28日

首次发布 (估计)

2012年10月2日

研究记录更新

最后更新发布 (估计)

2012年10月2日

上次提交的符合 QC 标准的更新

2012年9月28日

最后验证

2012年9月1日

更多信息

与本研究相关的术语

其他研究编号

  • H-20952
  • R21HD054836-02 (美国 NIH 拨款/合同)

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

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