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

Not Applicable

• Conditions: Cognitive Function; Physical Activity; Children; Behavior, Child

• Registration Number: NCT05020041
• Lead Sponsor: Universidad Autónoma de Chile

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-05-05
• Study Start: 2021-07-22
• Status Verified: 2021-08
• Study First Submitted QC: 2021-08-20
• Last Update Submitted: 2021-08-20
• Study First Posted: 2021-08-25
• Last Update Posted: 2021-08-25
• Primary Completion: 2021-09
• Study Completion: 2021-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 300

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Physical activity	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	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 Outcome Measures

Name	Time	Method
Flowmetry	change baseline up to 5 months	Flowmetry will be analyzed using the mean of three measurements recorded with the pediatric Mini wright (400l/m).
Hand grip strength	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

Trial Locations

Locations (1)

Universidad Autónoma de Chile; 🇨🇱 Talca, Región Del Maule, Chile