Fit, Healthy and Smart Preschool Children: PREFIT-Chile (PREFIT-Chile)

September 14, 2020 updated by: Johana Soto Sánchez, Playa Ancha University

Preschool Children: Fit, Healthy and Smart: PREFIT-Chile - Study Linking Physical Fitness to Non Invasive Health-Related Markers and Executive Function

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.

Study Overview

Status

Completed

Conditions

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

Study Type

Observational

Enrollment (Actual)

868

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Chile
      • Valparaíso, Chile, 2340000
        • Playa Ancha University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

4 years to 5 years (CHILD)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

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

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Measurement of "Physical fitness"
Time Frame: "1 Day" on "45 minute"
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.
"1 Day" on "45 minute"

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Measurement "Blood Pressure"
Time Frame: "1 Day" on "15 minutes"
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.
"1 Day" on "15 minutes"
Estimated "Body Mass Index"
Time Frame: "1 Day" on "10 minute"
Measured the weight (kg) and Height (m), then applicate the equation weight/height^2 to determinate de value.
"1 Day" on "10 minute"
Measurement "Waist circumference"
Time Frame: "1 Day" on "10 minutes"
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.
"1 Day" on "10 minutes"
Measurement "neck circumference"
Time Frame: "1 Day" on "10 minute"
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
"1 Day" on "10 minute"
Measurement "Physical activity"
Time Frame: "7 Days"
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
"7 Days"
Measurement "Motor Skills"
Time Frame: "1 Day" "45 minutes"
the standardized instrument called Test of Gross Motor Development (TGMD-2) will be used. Which measures 12 gross motor skills
"1 Day" "45 minutes"
Measurement "Neuropsychological development"
Time Frame: "1Day" "30 minutes"
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)
"1Day" "30 minutes"

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Playa Ancha University

Collaborators

Universidad de Granada
University of Chile

Investigators

  • Principal Investigator: Johana P Soto-Sánchez, PhD, Playa Ancha University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

June 1, 2019

Primary Completion (ACTUAL)

March 30, 2020

Study Completion (ACTUAL)

March 30, 2020

Study Registration Dates

First Submitted

February 7, 2020

First Submitted That Met QC Criteria

February 12, 2020

First Posted (ACTUAL)

February 13, 2020

Study Record Updates

Last Update Posted (ACTUAL)

September 16, 2020

Last Update Submitted That Met QC Criteria

September 14, 2020

Last Verified

September 1, 2020

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • REDI 170474

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Child, Preschool

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Oman

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe