Effects of an Active Break Program at Primary School (Activa-Mente)

December 27, 2023 updated by: Nicolas Aguilar Farias, Universidad de La Frontera

Effects of an Active Break Program at School on Physical Activity and On-task Behavior in Children From 6 to 12 Years Old

The purpose of this study is to assess the effectiveness of an active break program at school on physical activity levels and enjoyment, and on-task behavior in children.

Study Overview

Status

Active, not recruiting

Intervention / Treatment

Detailed Description

The protocol will include third and fourth-grade students (children aged 8 to 10 years) from elementary schools in the Valparaíso Region, Chile. Four school classes from two schools (intervention and control school) will be included. The intervention school will carry out the active break program, ACTIVA-MENTE This program consists of the application of a 4-and-a-half-minute video with moderate to vigorous-intensity physical activity. These breaks will take place 6 times a day in classes for 6 weeks.

Study Type

Interventional

Enrollment (Estimated)

60

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 Contact

Study Locations

      • Valparaíso, Chile
        • Facultad de Ciencias de la Actividad Física y del Deporte

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

8 years to 10 years (Child)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Schoolchildren aged 8 to 10 years old (third to fourth grade of primary education).

Exclusion Criteria:

  • Children with school attendance lower than 90 per cent (excluded from data analysis).
  • Any medical condition that impedes physical activity breaks.

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: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Activa-Mente (Intervention)
The active break program involves the presentation of video (4.5 min) with moderate-to-vigorous physical activities. These active breaks will be performed 6 times per day during 6 weeks.
Active break program
No Intervention: Control group
This group of students will not be exposed to the intervention.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Physical activity
Time Frame: 6 weeks
Physical activity will be measured with waist-worn ActiGraph GT3X+ accelerometers for seven days. Physical activity intensities will be derived from the accelerometer counts. Evenson cut points will be used to classify counts into physical activity intensities. Physical activity will be classified as light, moderate-to-vigorous and total physical activity.
6 weeks
On-task behavior
Time Frame: 6 weeks
The Direct Behaviour Rating Scale will be used to measure on-task behavior at the individual level. This scale measures academically engaged, respectful and disruptive behavior. For each domain, the scale uses a per cent grading system in which 0% indicates 'never' while 100% indicates 'always'. At the group level, the Classroom Behaviour and Assets Survey will be used teachers who will be asked to indicate the proportion of the class displaying on-task behavior as defined by the individual behavior tool. Response options include: 0 (0 students), 1 (1-2 students), 2 (a few students), 3 (about ¼ of the class), 4 (about ½ of the class), 5 (about ¾ of the class), 6 (most of the class), and 7 (all of the class).
6 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Physical activity enjoyment
Time Frame: 6 weeks
The Physical Activity Enjoyment Scale (PACES) will be used to measure enjoyment during the active breaks. Each of the 14 items of this instrument includes a Likert-type scale that ranges from 1 (Disagree a lot) to 5 (Agree a lot).
6 weeks

Collaborators and Investigators

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

Investigators

  • Principal Investigator: Tomas Reyes, PhD, Playa Ancha University

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)

November 1, 2022

Primary Completion (Actual)

October 20, 2023

Study Completion (Estimated)

April 30, 2024

Study Registration Dates

First Submitted

May 31, 2022

First Submitted That Met QC Criteria

May 31, 2022

First Posted (Actual)

June 3, 2022

Study Record Updates

Last Update Posted (Estimated)

January 1, 2024

Last Update Submitted That Met QC Criteria

December 27, 2023

Last Verified

December 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

  • UPLA-005-2022

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

The anonymized and raw data supporting the conclusions of this study will be made available by the principal investigator, upon reasonable request.

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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