ClinicalTrials.gg
CompletedNCT04269135PREFIT-ChileUpdated Sep 16, 2020

Fit, Healthy and Smart Preschool Children: PREFIT-Chile

An observational study in Child, Preschool, sponsored by Playa Ancha University. Completed at 1 site in Chile. Open to participants aged 4 Years to 5 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-09-16.

Sponsored by Playa Ancha University · Observational

Study type
Observational
Model
Case-only
Time perspective
Cross-sectional
Enrollment
868
Ages
4 Years to 5 Years
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 53 studies in Motor Activity with a site in Chile — 16 open to participants now, 19 under way, none of them phase 3. Motor Activity · Chile.

Started
2019
with 3 others
Observational
4 of 53
1 open now
Registered
11th of 53
by date

Among the 53 studies in Motor Activity with a site in Chile, this one is one of 4 that started in 2019, is one of 4 observational ones, and was the 11th registered.

Motor Activity

9,798 studies on the registry are indexed under Motor Activity; 1,910 are open to participants now.

Browse Motor Activity studies →

Open to participants now

16 of the 53 studies in Motor Activity with a site in Chile are open now. Recruiting first, the newest first:

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All 16 open studies →

A study can be open while its sites in Chile have not opened yet or have stopped. Only those recruiting at a site in Chile →

Who these studies take

Of the 1,201 Motor Activity studies recruiting now, 517 (43%) set no upper age limit and 535 (45%) stop at 75 or younger; 180 take children under 18; 420 take healthy volunteers.

This study: 4 Years to 5 Years · all sexes · healthy volunteers too.

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02

Study summary

Introduction: Investigating the interrelationship between physical condition, non-invasive health markers and executive function in preschoolers, is based on the current health and cognitive development situation of this population, especially the low socioeconomic level. National figures estimate that the prevalence of overweight / obesity in the preschool population reaches 53.6%, exposing not only the development of cardiovascular and metabolic diseases, but also affect cognitive potential.

Physical condition is a powerful health marker independent of nutritional status. Its evaluation together with the evaluation of non-invasive health markers and executive function in preschoolers inside educational establishments is essential to investigate alterations at an early age that could be prevented with adequate interventions in schools. However, to achieve this, valid, reliable and comparable tools are needed internationally.

Objective: to analyze the factors that affect the configuration of a diagnostic model which includes the physical fitness and physical activity levels, motor development, non-invasive risk factors and neuropsychological development in preschoolers.

Methods: Observational study, case only, cross sectional. Enrollment 544 preschool child 4 to 5 years old. Primary Outcome is Physical fitness to "Prefit Battery", Secondary outcome non-invasive risk factors (Blood pressure, BMI, Waist circumference, neck circumference) Physical activity, Motor skills and Neuropsychological development.

expected results: Determine the degree of association of physical fitness with non-invasive risk factors and neuropsychological development in preschoolers, determine the influence that physical activity level and motor development have on physical fitness and development a diagnostic model which includes the physical fitness and physical activity levels, motor development, non-invasive risk factors and neuropsychological development in Chilean preschoolers.

Read the detailed description

In recent years it has been demonstrated that physical fitness , which is linked to a higher level of physical activity has a positive effect on the health status of adults, adolescents and children, especially by lowering the probability of developing overweight and/or obesity. At the same time, recent research has shown that there is a positive relationship between fitness with brain structure and executive function in children.

In Chile, overweight and obesity constitute a public health problem in children. National figures show that the prevalence of overweight / obesity among preschool children reached 53.6% in 2018 exposing the children not only the development of cardiovascular and metabolic diseases , but also affecting motor and cognitive development. Obesity has been shown to influence a country´s economic development, such as salary and productivity. The Economic Commission for Latin America and the Caribbean in 2017 determined that the health cost derived from obesity In Chile was equivalent to 0,2% of the national Gross Domestic Product. It is expected that by 2078, the estimated annual cost produced by an increasing prevalence overweight / obesity will be approximately 1 billion dollars.

Because it is not economically viable in Chile to determine in every overweight/obese child the probability of developing chronic diseases later in life, it is of utmost importance to have valid, simple and reliable indicators to discriminate at an early age, children that are at greatest risk. In this respect, physical fitness appears as a powerful health marker independent of the nutritional status. Evaluation of fitness as well as that of non-invasive health markers, motor development and neuropsychological development in preschool children in schools, constitute an excellent opportunity to investigate at an early age, alterations that could be prevented with adequate interventions in schools that would probably be significantly less costly than interventions applied later on. To achieve this goal, valid and reliable tools have to be developed that are also comparable with similar ones developed elsewhere.

With this background, The research objective is to analyze the factors that affect the configuration of a diagnostic model which includes the physical fitness and physical activity levels, motor development, non-invasive risk factors and neuropsychological development in preschoolers.

The hypothesis is that there is a positive association between physical fitness, non-invasive health markers and neuropsychological functions in preschool children, thus enabling to generate a predictive diagnostic model based on physical fitness.

  1. The primary outcome is to determine the degree of association of physical fitness with non-invasive risk factors and neuropsychological development in preschoolers
  2. The second outcome is to determine the influence that physical activity level and motor development have on physical fitness among preschool children.

This research aims a) to establish that physical fitness in preschool children may be considered as a diagnostic tool of the health status of children (independent of their nutritional status), and b) to determine the possible impact that the physical fitness level has on neuropsychological development

03

Conditions studied

  • Child, Preschool

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Keywords

  • Physical fitness
  • Risk factors
  • Anthropometrics
  • Blood pressure
  • Neuropsychological Tests
  • Physical activity
  • Motor skills
04

Who can participate

Ages eligible
4 Years to 5 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

Preschoolers from 4 to 5 years old, incorporated into the school system and attending kindergartens and schools, residents of the central area of Chile, to detail IV region of "Coquimbo", V region of "Valparaíso", VI region of the "Liberator Bernardo O'Higgins" and the "Metropolitan" Region

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

  • Preschool child, 4 to 5 years old, Speaking Spanish and Agree to the commitment

Exclusion criteria

Exclusion Criteria:

  • Chronic pediatric disease (except for obesity) Cardiovascular or metabolic disease, neurological, respiratory bronchial disease and Orthopedic limitation.
05

Study design

Observational model
Case-only
Time perspective
Cross-sectional
Enrollment
868 participants (actual)
Patient registry
No
06

What researchers measure

Primary outcomes

  1. Measurement of "Physical fitness"

    Results from PREFIT battery; is composed of the following tests: the 20 m shuttle-run test for assessing cardiorespiratory fitness, the handgrip-strength and the standing long-jump tests for assessing muscular musculoskeletal fitness, and the 4x10 m shuttle-run.

    Time frame: "1 Day" on "45 minute"

Secondary outcomes

  1. Measurement "Blood Pressure"

    Measured in the right arm, The child stay a quiet for 3-5 min before measurement, with the back supported and feet uncrossed on the floor.

    Time frame: "1 Day" on "15 minutes"

  2. Estimated "Body Mass Index"

    Measured the weight (kg) and Height (m), then applicate the equation weight/height\^2 to determinate de value.

    Time frame: "1 Day" on "10 minute"

  3. Measurement "Waist circumference"

    The child stands erect with the abdomen relaxed, the arms at the sides and the feet together. The tester faces the child and places an inelastic tape around him / her, in a horizontal plane, The measurement will be made at the level of the navel and so that the tape forms a horizontal plane parallel to the ground.

    Time frame: "1 Day" on "10 minutes"

  4. Measurement "neck circumference"

    The child stands tall, arms at the sides and feet together. The tester looks at the Child and places an inelastic tape around of thyroid cartilage

    Time frame: "1 Day" on "10 minute"

  5. Measurement "Physical activity"

    The equipment will be located in the right hip area with an adjustable elastic belt. Record the information with an interval of 15 seconds (time) with a frequency of 100 Hz, the above is executed by means of the Actilife-6 software

    Time frame: "7 Days"

  6. Measurement "Motor Skills"

    the standardized instrument called Test of Gross Motor Development (TGMD-2) will be used. Which measures 12 gross motor skills

    Time frame: "1 Day" "45 minutes"

  7. Measurement "Neuropsychological development"

    It will be evaluated by means of standardized tests, battery of child computerized neuropsychological evaluation (BENCI), which requires children to perform a series of activities on an iPad, where the following functions will be evaluated: Visomotor coordination, Processing speed, Language and Executive function (only in 5 years)

    Time frame: "1Day" "30 minutes"

07

Study locations

1 site
  • Playa Ancha University
    Valparaíso, 2340000, Chile
08

References and documents

Publications

  • Burkhalter TM, Hillman CH. A narrative review of physical activity, nutrition, and obesity to cognition and scholastic performance across the human lifespan. Adv Nutr. 2011 Mar;2(2):201S-6S. doi: 10.3945/an.111.000331. Epub 2011 Mar 10. PubMed 22332052 ↗
  • Chaddock-Heyman L, Erickson KI, Holtrop JL, Voss MW, Pontifex MB, Raine LB, Hillman CH, Kramer AF. Aerobic fitness is associated with greater white matter integrity in children. Front Hum Neurosci. 2014 Aug 19;8:584. doi: 10.3389/fnhum.2014.00584. eCollection 2014. PubMed 25191243 ↗
  • Chaddock-Heyman L, Hillman CH, Cohen NJ, Kramer AF. III. The importance of physical activity and aerobic fitness for cognitive control and memory in children. Monogr Soc Res Child Dev. 2014 Dec;79(4):25-50. doi: 10.1111/mono.12129. PubMed 25387414 ↗
  • Junta Nacional Escolar de Auxilio y Becas (JUNAEB). Informe Mapa Nutricional 2018 de Chile. Lira, M. 2019
  • Fernández, A., Martínez, R., Carrasco, I., & Palma, A. (2017). Impacto social y económico de la malnutrición: modelo de análisis y estudio piloto en Chile, el Ecuador y México. Retrieved from https://www.cepal.org/es/publicaciones/41247-impacto-social-economico-la-malnutricion-modelo-analisis-estudio-piloto-chile
  • Ortega FB, Cadenas-Sanchez C, Sanchez-Delgado G, Mora-Gonzalez J, Martinez-Tellez B, Artero EG, Castro-Pinero J, Labayen I, Chillon P, Lof M, Ruiz JR. Systematic review and proposal of a field-based physical fitness-test battery in preschool children: the PREFIT battery. Sports Med. 2015 Apr;45(4):533-55. doi: 10.1007/s40279-014-0281-8. PubMed 25370201 ↗

Individual participant data

Plan to share: No

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Jun 2019 to primary completion in Mar 2020, 9 months.

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

Registered
Feb 7, 2020
First posted
Feb 13, 2020
StartActual
Jun 1, 2019
Primary completionActual
Mar 30, 2020
CompletionActual
Mar 30, 2020
Last update
Sep 16, 2020
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 Sep 16, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04269135
Lead sponsor
Playa Ancha University
Responsible party
Johana Soto Sánchez (Physical Education Teacher, Playa Ancha University) — Principal investigator
First posted
Feb 13, 2020
Start date
Jun 1, 2019
Primary completion
Mar 30, 2020
Completion
Mar 30, 2020
Last update
Sep 16, 2020

Study contacts

Johana P Soto-Sánchez, PhD
principal investigator · Playa Ancha University

Oversight

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

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This study is completed, as verified in Sep 2020. You cannot join it, but the record below documents what was studied.

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