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

NCT05020041 | Unknown

• 1 other identifier: 01-20
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

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

Conditions

Cognitive Function; Physical Activity; Children; Behavior, Child

Outcome Measures

Primary Outcomes (2)

• Physical activity

  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

  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

Secondary Outcomes (2)

• Flowmetry

  change baseline up to 5 months

• Hand grip strength

  change baseline up to 5 months

Study Arms (2)

Intervention

EXPERIMENTAL

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.

Behavioral: Physical activity

Control

NO INTERVENTION

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.

Interventions

Physical activity BEHAVIORAL

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.

Also known as: Cognitive function

Intervention

Eligibility Criteria

• Age: 5 Years - 8 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

Sponsors & Collaborators

• Universidad Autónoma de Chile: lead
• Ministry of Sport, Chile: collaborator

Study Sites (1)

Universidad Autónoma de Chile

Talca, Maule Region, 3467987, Chile

Location

MeSH Terms

Conditions

Motor Activity; Child Behavior

Interventions

Exercise; Neuropsychological Tests

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Psychological Tests; Behavioral Disciplines and Activities

Study Officials

• Natalia Bustamante-Ara, PhD

  Universidad Autónoma de Chile

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, PhD Natalia Bustamante-Ara

Study Record Dates

• First Submitted: May 5, 2021
• First Posted: August 25, 2021
• Study Start: July 22, 2021
• Primary Completion: September 1, 2021
• Study Completion: December 1, 2021
• Last Updated: August 25, 2021

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will not share

Locations

CL (1)