Skip to main content
Clinical Trials/NCT05020041
NCT05020041
Unknown
Not Applicable

Change Physical Activity and School Play Space. Randomized Study Protocol.

Universidad Autónoma de Chile1 site in 1 country300 target enrollmentJuly 22, 2021

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Cognitive Function
Sponsor
Universidad Autónoma de Chile
Enrollment
300
Locations
1
Primary Endpoint
Physical activity
Last Updated
4 years ago

Overview

Brief Summary

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

Registry
clinicaltrials.gov
Start Date
July 22, 2021
End Date
December 2021
Last Updated
4 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Universidad Autónoma de Chile
Responsible Party
Principal Investigator
Principal Investigator

Natalia Bustamante

Principal Investigator, PhD Natalia Bustamante-Ara

Universidad Autónoma de Chile

Eligibility Criteria

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.

Outcomes

Primary Outcomes

Physical activity

Time Frame: 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.

Cognitive function

Time Frame: 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.

Secondary Outcomes

  • Flowmetry(change baseline up to 5 months)
  • Hand grip strength(change baseline up to 5 months)

Study Sites (1)

Loading locations...

Similar Trials