Physical Activiy Intervention Programm

Sponsor

Universidad Autónoma de Chile (Other)

Overall Status

Unknown status

CT.gov ID

NCT04194580

Collaborator

(none)

800

Enrollment

Location

Arms

12.6

Anticipated Duration (Months)

63.6

Patients Per Site Per Month

Study Details

Study Description

Brief 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

Condition or Disease	Intervention/Treatment	Phase
Physical Activity Fitness Overweight and Obesity	Behavioral: Phisical activity intervention	N/A

Detailed Description

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

Study Design

Study Type:

Interventional

Anticipated Enrollment :

800 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Prevention

Official Title:

Effectiveness of a Physical Activity Intervention on the Overweight and Obesity of Chilean Schoolchildren

Actual Study Start Date :

Dec 3, 2019

Anticipated Primary Completion Date :

Jul 20, 2020

Anticipated Study Completion Date :

Dec 20, 2020

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Physical activity In the program we will perform a recreational physical activity intervention during one year that include standardized recreative and non competitive activities conducted by sports instructors	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.
No Intervention: Physical activity control This group will not participate in the intervention

Arm

Intervention/Treatment

Experimental: Physical activity

In the program we will perform a recreational physical activity intervention during one year that include standardized recreative and non competitive activities conducted by sports instructors

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.

No Intervention: Physical activity control

This group will not participate in the intervention

Outcome Measures

Primary Outcome Measures

Aerobic Capacity [1 year]
By using 20-m shuttle run test, which is validated to measure maximal aerobic capacity in children from 4 years.
Muscle Strength [1 year]
By using standing long jump test
Flexibility [1 year]
By using the sit and reach test
Speed-agility [1 year]
By using 4x10 meters shuttle run test

Secondary Outcome Measures

Health-related quality of life [1 year]
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

4 Years to 18 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Laboratorio Fisiología del Ejercicio	Temuco	La Araucanía	Chile	4780000

Sponsors and Collaborators

Universidad Autónoma de Chile

Investigators

Study Director: José Bruneau, PhD, Universidad Autónoma de Chile

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Andrés Godoy Cumillaf, Profesor, Universidad Autónoma de Chile

ClinicalTrials.gov Identifier:

NCT04194580

Other Study ID Numbers:

UAChile

First Posted:

Dec 11, 2019

Last Update Posted:

Dec 11, 2019

Last Verified:

Dec 1, 2019

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Obesity

Overweight

Study Results

No Results Posted as of Dec 11, 2019