NCT04194580

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

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
800

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Dec 2019

Geographic Reach
1 country

1 active site

Status
unknown

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

First Submitted

Initial submission to the registry

December 3, 2019

Completed
Same day until next milestone

Study Start

First participant enrolled

December 3, 2019

Completed
8 days until next milestone

First Posted

Study publicly available on registry

December 11, 2019

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 20, 2020

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 20, 2020

Completed
Last Updated

December 11, 2019

Status Verified

December 1, 2019

Enrollment Period

8 months

First QC Date

December 3, 2019

Last Update Submit

December 10, 2019

Conditions

Outcome Measures

Primary Outcomes (4)

  • Aerobic Capacity

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

    1 year

  • Muscle Strength

    By using standing long jump test

    1 year

  • Flexibility

    By using the sit and reach test

    1 year

  • Speed-agility

    By using 4x10 meters shuttle run test

    1 year

Secondary Outcomes (1)

  • Health-related quality of life

    1 year

Study Arms (2)

Physical activity

EXPERIMENTAL

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

Physical activity control

NO INTERVENTION

This group will not participate in the intervention

Interventions

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.

Physical activity

Eligibility Criteria

Age4 Years - 18 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Laboratorio Fisiología del Ejercicio

Temuco, La Araucanía, 4780000, Chile

RECRUITING

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Motor ActivityOverweightObesity

Condition Hierarchy (Ancestors)

BehaviorOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • José Bruneau, PhD

    Universidad Autónoma de Chile

    STUDY DIRECTOR

Central Study Contacts

Andrés Godoy, Prof.

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Profesor

Study Record Dates

First Submitted

December 3, 2019

First Posted

December 11, 2019

Study Start

December 3, 2019

Primary Completion

July 20, 2020

Study Completion

December 20, 2020

Last Updated

December 11, 2019

Record last verified: 2019-12

Locations