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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04194580
Other study ID # UAChile
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date December 3, 2019
Est. completion date December 20, 2020

Study information

Verified date December 2019
Source Universidad Autónoma de Chile
Contact Andrés Godoy, Prof.
Phone +56932259064
Email andres.godoy@uautonoma.cl
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The purpose of this study is to evaluate the effectiveness of a recreational physical activity intervention for reducing the prevalence of overweight/obesity and other cardiovascular risk factors


Description:

A greater intensity of the intervention, and a longer weekly duration that extends until the weekend, could improve the efficiency in obesity.


Recruitment information / eligibility

Status Recruiting
Enrollment 800
Est. completion date December 20, 2020
Est. primary completion date July 20, 2020
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 4 Years to 18 Years
Eligibility Inclusion Criteria:

- The parents of the children will be informed about the objectives and methods of the study, and will give their written consent to the participation of the children. Similarly, the study will introduce children from classroom to class and their oral consent will be obtained

Exclusion Criteria:

- Participating children will be free from serious learning difficulties, or physical or mental disorders, that could prevent participation in scheduled physical activities.

Study Design


Intervention

Behavioral:
Phisical activity intervention
The prevalence of overweight in chilean children in the among the highest in the world and increasing quickly. The investigators recently evaluated an after-school program of recreational physical activity to control overweight, obesity and other cardiovascular risk factors in primary school children Temuco. This program reduced adiposity and increased the fitness.

Locations

Country Name City State
Chile Laboratorio Fisiología del Ejercicio Temuco La Araucanía

Sponsors (1)

Lead Sponsor Collaborator
Universidad Autónoma de Chile

Country where clinical trial is conducted

Chile, 

Outcome

Type Measure Description Time frame Safety issue
Primary Aerobic Capacity By using 20-m shuttle run test, which is validated to measure maximal aerobic capacity in children from 4 years. 1 year
Primary Muscle Strength By using standing long jump test 1 year
Primary Flexibility By using the sit and reach test 1 year
Primary Speed-agility By using 4x10 meters shuttle run test 1 year
Secondary Health-related quality of life By using the instrument for assessing Health-Related Quality of Life for children and adolescents aged 4-17 years (KINDL), in its version validated in Spanish. The KINDLR questionnaire consists of 24 Likert-scaled items associated with six dimensions: physical well-being, emotional well-being, self-esteem, family, friends and everyday functioning (school or nursery school/kindergarten). The sub-scales of these six dimensions can be combined to produce a total score. the score ranges from 0 to 100. Higher scores indicate better health-related quality of life. 1 year
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