ClinicalTrials.gg
Status unknownNCT05020041Play&CognitionUpdated Aug 25, 2021

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

An interventional study of Physical activity in Cognitive Function, Physical Activity and Children, sponsored by Universidad Autónoma de Chile. Status unknown at 1 site in Chile. Open to participants aged 5 Years to 8 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-08-25.

Primary conditionChild BehaviorRegistry: Motor ActivityReclassifiedWhy we changed it
Registry
Motor Activity — the first condition term the registry derived for this study.
ClinicalTrials.gg
Child Behavior
Why
  1. Motor Activity is a broad heading, used only when no more specific condition is named.
  2. The study's listed conditions name Child Behavior.
Confidence
High: the new condition is named in the study's own listed conditions. Of 351 hand-checked studies reclassified this way, 68% were exactly right and 84% in the right disease family; the registry's first term was right for 5% (measured 2026-10-21). How we classify →
Wrong?
Tell us the study's main condition →

Sponsored by Universidad Autónoma de Chile · Not applicable, Interventional, and Other

The sponsor has not verified this record recently (last verified Aug 2021), so the status shown — last known as Enrolling by invitation — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
300
Allocation
Randomized
Ages
5 Years to 8 Years
Sex
All
01

Study 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

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Conditions studied

  • Cognitive Function
  • Physical Activity
  • Children
  • Behavior, Child

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03

In context

Child Behavior Reclassified

224 studies on the registry are indexed under Child Behavior; 41 are open to participants now.

This study's planned enrollment of 300 is above the median of 140 across 197 interventional studies indexed under Child Behavior.

Browse Child Behavior studies →

Lead sponsor

Universidad Autónoma de Chile is the lead sponsor of 4 studies on the registry; 2 are open to participants now.

Compared within Child Behavior, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Motor Activity. The counts are of registry records indexed under each term, refreshed daily. How we classify →

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Who can participate

Ages eligible
5 Years to 8 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion Criteria:

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

Phase
Not applicable
Primary purpose
Other
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
300 participants (estimated)

Study arms

  • Experimental
    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.

    Behavioral: Physical activity

  • No intervention
    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.

Interventions

  • BehavioralPhysical activity

    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

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What researchers measure

Primary outcomes

  1. Physical activity

    Accelerometry data will be valid if they present ≥ 3 days of measurement with a minimum of 9 hours of use per day.

    Time frame: change baseline up to 5 months

  2. 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.

    Time frame: change baseline up to 5 months

Secondary outcomes

  1. Flowmetry

    Flowmetry will be analyzed using the mean of three measurements recorded with the pediatric Mini wright (400l/m).

    Time frame: change baseline up to 5 months

  2. Hand grip strength

    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

    Time frame: change baseline up to 5 months

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Study locations

1 site
  • Universidad Autónoma de Chile
    Talca, Región Del Maule 3467987, Chile
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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

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Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Jul 2021 (actual). Primary completion is estimated for Sep 2021, 2 months after the start.

Of 140 non-industry interventional studies with no phase under Child Behavior, half reached primary completion within 20 months of starting (the median), counting those still running; a quarter within 8 and three quarters within 42. This study's planned 2 months is below that.

Counting every sponsor, half of 141 studies reached it within 20 months; a quarter within 8 and three quarters within 41.

How these figures are worked out, and which studies are left out of them.

Registered
May 5, 2021
First posted
Aug 25, 2021
StartActual
Jul 22, 2021
Primary completionEst.
Sep 2021
CompletionEst.
Dec 2021
Last update
Aug 25, 2021
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Aug 25, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT05020041
Lead sponsor
Universidad Autónoma de Chile
Collaborators
Ministry of Sport, Chile
Responsible party
Natalia Bustamante (Principal Investigator, PhD Natalia Bustamante-Ara, Universidad Autónoma de Chile) — Principal investigator
First posted
Aug 25, 2021
Start date
Jul 22, 2021
Primary completion
Sep 2021 (estimated)
Completion
Dec 2021 (estimated)
Last update
Aug 25, 2021

Study contacts

Natalia Bustamante-Ara, PhD
principal investigator · Universidad Autónoma de Chile

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Aug 2021. You cannot join it, but the record below documents what was studied.

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