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Change Physical Activity and School Play Space. Randomized Study Protocol. (Play&Cognition)

2021年8月20日 更新者:Natalia Bustamante、Universidad Autónoma de Chile
Physical activity is a factor that contributes to a motor and cognitive development in early childhood. Currently, childhood obesity has grown steadily in Chile. This study aims to evaluate the impact of a school environmental intervention on the physical activity and cognitive functions in 1st-grade schoolchildren during the COVID-19 pandemic. The study will use a randomized experimental design with a sample of 300 schoolchildren divided into a control and an intervention group (n=150 each group). Sociodemographic characteristics and lifestyle of the schoolchildren will be obtained through a questionnaire answered by parents/guardians. Cognitive function will be evaluated using the TENI test by tablet and physical activity will be measured during 7 consecutive days using accelerometers (Actigraph GT3X and wGT3X-BT). Both groups will receive a lecture aimed at schoolchildren. Teachers of the intervention group will also receive a talk regarding the intervention that will take place in their school environment, which includes a circuit of psychomotor games painted on the recess playground floor. ANCOVA analysis will be performed, adjusted for age and sex; then, a multivariate linear regression model will be applied considering the significant variables and adjustment. The significance level will be p<.05. SPSSv25 and R version 3.14 will be used for the analyses. The intervention is expected to contribute to the increase of physical activity favoring the school environment within a context of vulnerability and with a low-cost initiative

研究概览

研究类型

介入性

注册 (预期的)

300

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

    • Región Del Maule
      • Talca、Región Del Maule、智利、3467987
        • Universidad Autónoma de Chile

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

5年 至 8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:

  • The inclusion criteria for the participating students are a) children enrolled in 1st-grade in municipal schools in the city of Talca; b) without impediments to physical activity; c) able to understand an order considering their age; d) residents in the commune of Talca; and e) with a commitment not to change school or residence during the duration of the project.

Exclusion Criteria:

  • The exclusion criteria are presenting any medical condition that prevents the development of the evaluations and/or presenting any behavioral disorder condition.

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:其他
  • 分配:随机化
  • 介入模型:并行分配
  • 屏蔽:单身的

武器和干预

参与者组/臂
干预/治疗
实验性的:Intervention

The implementation of painted games will consist of adapting a space destined for recreation, designing a psychomotor circuit that does not require contact between peers, or manipulation of objects to maintain COVID-19 sanitary and safety protocols.

The schools in the intervention group will receive the online educational talk aimed at schoolchildren and a talk aimed at Physical Education teachers.

The schools in the intervention group will receive the online educational talk aimed at schoolchildren and a talk aimed at Physical Education teachers, given that they are fundamental for the development of habits in the school stage; besides, painted games will be implemented in the school playground.

The implementation of painted games will consist of adapting a space destined for recreation, designing a psychomotor circuit that does not require contact between peers or manipulation of objects in order to maintain COVID-19 sanitary and safety protocols. The psychomotor circuit includes a line circuit, a jumping sequence game, and a letter spiral. All the games will be implemented in a space within the educational establishment to which the students will have access during recess. The game designs involve activities to develop motor patterns such as jumping with different supports, running, and dynamic balance.

其他名称:
  • 认知功能
无干预:Control
The schools participating in the control group will receive an online educational talk aimed at promoting healthy habits and the benefits of physical activity inside and outside the school environment.

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
Physical activity
大体时间:change baseline up to 5 months
Accelerometry data will be valid if they present ≥ 3 days of measurement with a minimum of 9 hours of use per day.
change baseline up to 5 months
Cognitive function
大体时间:change baseline up to 5 months
The battery is composed of 8 games to assess the functioning of attention, visuospatial and visuomotor development, memory system, language, and executive functions in children aged 3 to 9 years. Test, TENI.
change baseline up to 5 months

次要结果测量

结果测量
措施说明
大体时间
Flowmetry
大体时间:change baseline up to 5 months
Flowmetry will be analyzed using the mean of three measurements recorded with the pediatric Mini wright (400l/m).
change baseline up to 5 months
Hand grip strength
大体时间:change baseline up to 5 months
Manual grip strength will be assessed three times on the dominant arm using a digital dynamometer (TKK504) fitted to the palm of the schoolchild's hand
change baseline up to 5 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。

调查人员

  • 首席研究员:Natalia Bustamante-Ara, PhD、Universidad Autónoma de Chile

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 (实际的)

2021年7月22日

初级完成 (预期的)

2021年9月1日

研究完成 (预期的)

2021年12月1日

研究注册日期

首次提交

2021年5月5日

首先提交符合 QC 标准的

2021年8月20日

首次发布 (实际的)

2021年8月25日

研究记录更新

最后更新发布 (实际的)

2021年8月25日

上次提交的符合 QC 标准的更新

2021年8月20日

最后验证

2021年8月1日

更多信息

与本研究相关的术语

其他研究编号

  • 01-20

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

药物和器械信息、研究文件

研究美国 FDA 监管的药品

研究美国 FDA 监管的设备产品

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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