Fit, Healthy and Smart Preschool Children: PREFIT-Chile

Sponsor

Playa Ancha University (Other)

Overall Status

Completed

CT.gov ID

NCT04269135

Collaborator

University of Chile (Other), Universidad de Granada (Other)

868

Enrollment

Location

Actual Duration (Months)

87.2

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Child, Preschool

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.

The primary outcome is to determine the degree of association of physical fitness with non-invasive risk factors and neuropsychological development in preschoolers
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 Design

Study Type:

Observational

Actual Enrollment :

868 participants

Observational Model:

Case-Only

Time Perspective:

Cross-Sectional

Official Title:

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

Actual Study Start Date :

Jun 1, 2019

Actual Primary Completion Date :

Mar 30, 2020

Actual Study Completion Date :

Mar 30, 2020

Outcome Measures

Primary Outcome Measures

Measurement of "Physical fitness" ["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.

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

4 Years to 5 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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.