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Physical Activiy Intervention Programm

Primary Purpose

Physical Activity, Fitness, Overweight and Obesity

Status

Unknown status

Phase

Not Applicable

Locations

Chile

Study Type

Interventional

Intervention

Phisical activity intervention

About this trial

This is an interventional prevention trial for Physical Activity

Eligibility Criteria

4 Years - 18 Years (Child, Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

Laboratorio Fisiología del EjercicioRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Physical activity

Physical activity control

Arm Description

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

This group will not participate in the intervention

Outcomes

Primary Outcome Measures

Aerobic Capacity

By using 20-m shuttle run test, which is validated to measure maximal aerobic capacity in children from 4 years.

Muscle Strength

By using standing long jump test

Flexibility

By using the sit and reach test

Speed-agility

By using 4x10 meters shuttle run test

Secondary Outcome Measures

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.

Full Information

NCT ID

NCT04194580

First Posted

December 3, 2019

Last Updated

December 10, 2019

Sponsor

Universidad Autónoma de Chile

1. Study Identification

Unique Protocol Identification Number

NCT04194580

Brief Title

Physical Activiy Intervention Programm

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

December 2019

Overall Recruitment Status

Unknown status

Study Start Date

December 3, 2019 (Actual)

Primary Completion Date

July 20, 2020 (Anticipated)

Study Completion Date

December 20, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Universidad Autónoma de Chile

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. 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

Detailed Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Physical Activity, Fitness, Overweight and Obesity

7. Study Design

Primary Purpose

Prevention

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

800 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Physical activity

Arm Type

Experimental

Arm Description

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

Arm Title

Physical activity control

Arm Type

No Intervention

Arm Description

This group will not participate in the intervention

Intervention Type

Behavioral

Intervention Name(s)

Phisical activity intervention

Intervention Description

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.

Primary Outcome Measure Information:

Title

Aerobic Capacity

Description

By using 20-m shuttle run test, which is validated to measure maximal aerobic capacity in children from 4 years.

Time Frame

1 year

Title

Muscle Strength

Description

By using standing long jump test

Time Frame

1 year

Title

Flexibility

Description

By using the sit and reach test

Time Frame

1 year

Title

Speed-agility

Description

By using 4x10 meters shuttle run test

Time Frame

1 year

Secondary Outcome Measure Information:

Title

Health-related quality of life

Description

Time Frame

1 year

10. Eligibility

Sex

All

Minimum Age & Unit of Time

4 Years

Maximum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Andrés Godoy, Prof.

Phone

+56932259064

andres.godoy@uautonoma.cl

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

José Bruneau, PhD

Organizational Affiliation

Universidad Autónoma de Chile

Official's Role

Study Director

Facility Information:

Facility Name

Laboratorio Fisiología del Ejercicio

City

Temuco

State/Province

La Araucanía

ZIP/Postal Code

4780000

Country

Chile

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Andrés Godoy, Prof.

Phone

+56932259064

andres.godoy@uautonoma.cl

12. IPD Sharing Statement

Citations:

PubMed Identifier

36181063

Citation

Godoy-Cumillaf A, Fuentes-Merino P, Giakoni-Ramirez F, Duclos-Bastias D, Merellano-Navarro E. Effectiveness of a physical activity intervention on the overweight and obesity of Chilean schoolchildren. Medicine (Baltimore). 2022 Sep 30;101(39):e30908. doi: 10.1097/MD.0000000000030908.

Results Reference

derived

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Physical Activiy Intervention Programm

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