Clinical trial NCT05020041: Change Physical Activity and School Play Space. Randomized Study Protocol.
Official title: Change Physical Activity and School Play Space. Randomized Study Protocol.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Cognitive Function
Physical Activity
Children
Behavior, Child
Lead sponsor: Universidad Autónoma de Chile
Sponsor class: OTHER
Collaborators: name: Ministry of Sport, Chile
First posted: 2021-08-25
Enrollment: 300
Sex: ALL
Minimum age (years): 5
Maximum age (years): 8
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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


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.

Primary outcomes:
measure: Physical activity
timeFrame: change baseline up to 5 months
measure: Cognitive function
timeFrame: change baseline up to 5 months
Secondary outcomes:
measure: Flowmetry
timeFrame: change baseline up to 5 months
measure: Hand grip strength
timeFrame: change baseline up to 5 months
Other outcomes:
Locations:
city: Talca
country: Chile
facility: Universidad Autónoma de Chile
state: Región Del Maule
Study officials:
affiliation: Universidad Autónoma de Chile
name: Natalia Bustamante-Ara, PhD
role: PRINCIPAL_INVESTIGATOR
References: