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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04269135
Recruitment Status : Recruiting
First Posted : February 13, 2020
Last Update Posted : February 13, 2020
Sponsor:
Collaborators:
University of Chile
Universidad de Granada
Information provided by (Responsible Party):
Johana Soto Sánchez, Playa Ancha University

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
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.

  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

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Study Type : Observational
Estimated Enrollment : 544 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 : June 1, 2019
Estimated Primary Completion Date : March 30, 2020
Estimated Study Completion Date : April 30, 2020

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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

  5. 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

  6. 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

  7. 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)



Information from the National Library of Medicine

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Ages Eligible for Study:   4 Years to 5 Years   (Child)
Sexes Eligible for Study:   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
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04269135


Contacts
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Contact: Johana P Soto-Sánchez, PhD +56 2500183 ext 183 jsoto@upla.cl
Contact: Tomás R Reyes Amigo, PhD +56 2500183 ext 183 tomas.reyes@upla.cl

Locations
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Chile
Playa Ancha University Recruiting
Valparaíso, Chile, 2340000
Contact: Paula A Magnere, MSc    +56 2500183 ext 183    pmagnere@upla.cl   
Sponsors and Collaborators
Playa Ancha University
University of Chile
Universidad de Granada
Investigators
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Principal Investigator: Johana P Soto-Sánchez, PhD Playa Ancha University

Publications of Results:
Other Publications:
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Responsible Party: Johana Soto Sánchez, Physical Education Teacher, Playa Ancha University
ClinicalTrials.gov Identifier: NCT04269135    
Other Study ID Numbers: REDI 170474
First Posted: February 13, 2020    Key Record Dates
Last Update Posted: February 13, 2020
Last Verified: February 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Johana Soto Sánchez, Playa Ancha University:
Physical fitness
Risk factors
Anthropometrics
Blood pressure
Neuropsychological Tests
Physical activity
Motor skills