NCT04269135

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
868

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2019

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2019

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

February 7, 2020

Completed
6 days until next milestone

First Posted

Study publicly available on registry

February 13, 2020

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 30, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 30, 2020

Completed
Last Updated

September 16, 2020

Status Verified

September 1, 2020

Enrollment Period

10 months

First QC Date

February 7, 2020

Last Update Submit

September 14, 2020

Conditions

Child, Preschool

Keywords

Physical fitnessRisk factorsAnthropometricsBlood pressureNeuropsychological TestsPhysical activityMotor skills

Outcome Measures

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.

    "1 Day" on "45 minute"

Secondary Outcomes (7)

  • Measurement "Blood Pressure"

    "1 Day" on "15 minutes"

  • Estimated "Body Mass Index"

    "1 Day" on "10 minute"

  • Measurement "Waist circumference"

    "1 Day" on "10 minutes"

  • Measurement "neck circumference"

    "1 Day" on "10 minute"

  • Measurement "Physical activity"

    "7 Days"

  • +2 more secondary outcomes

Eligibility Criteria

Age4 Years - 5 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)
Sampling MethodNon-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

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Playa Ancha University

Valparaíso, 2340000, Chile

Location

Related Publications (7)

  • 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.

    PMID: 22332052BACKGROUND

  • 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.

    PMID: 25191243RESULT

  • 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.

    PMID: 25387414RESULT

  • Junta Nacional Escolar de Auxilio y Becas (JUNAEB). Informe Mapa Nutricional 2018 de Chile. Lira, M. 2019

    RESULT

  • 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

    RESULT

  • 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.

    PMID: 25370201RESULT

  • Soto-Sanchez J, Leyton-Dinamarca B, Kain J, Fernandez-Valero P, Castro-Cisterna S, Arias-Tellez MJ, Ortega FB. Reliability of the PREFIT fitness-test battery in Chilean preschoolers. Front Pediatr. 2026 Jan 12;13:1654731. doi: 10.3389/fped.2025.1654731. eCollection 2025.

    PMID: 41602872DERIVED

MeSH Terms

Conditions

Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Study Officials

  • Johana P Soto-Sánchez, PhD

    Playa Ancha University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Physical Education Teacher

Study Record Dates

First Submitted

February 7, 2020

First Posted

February 13, 2020

Study Start

June 1, 2019

Primary Completion

March 30, 2020

Study Completion

March 30, 2020

Last Updated

September 16, 2020

Record last verified: 2020-09

Data Sharing

IPD Sharing
Will not share

Locations

CL(1)