Physical Activiy Intervention Programm

December 10, 2019 updated by: Andrés Godoy Cumillaf, Universidad Autónoma de Chile

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

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

800

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Chile
    • La Araucanía
      • Temuco, La Araucanía, Chile, 4780000
        • Recruiting
        • Laboratorio Fisiología del Ejercicio
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

4 years to 18 years (Child, Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Health-related quality of life
Time Frame: 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.
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universidad Autónoma de Chile

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 3, 2019

Primary Completion (Anticipated)

July 20, 2020

Study Completion (Anticipated)

December 20, 2020

Study Registration Dates

First Submitted

December 3, 2019

First Submitted That Met QC Criteria

December 10, 2019

First Posted (Actual)

December 11, 2019

Study Record Updates

Last Update Posted (Actual)

December 11, 2019

Last Update Submitted That Met QC Criteria

December 10, 2019

Last Verified

December 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UAChile

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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