NCT05403996

Brief Summary

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.

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
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2022

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

May 31, 2022

Completed
3 days until next milestone

First Posted

Study publicly available on registry

June 3, 2022

Completed
5 months until next milestone

Study Start

First participant enrolled

November 1, 2022

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 20, 2023

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2024

Completed
Last Updated

January 2, 2024

Status Verified

December 1, 2023

Enrollment Period

12 months

First QC Date

May 31, 2022

Last Update Submit

December 27, 2023

Conditions

Keywords

physical activityphysical activity enjoymenton-task behavior

Outcome Measures

Primary Outcomes (2)

  • Physical activity

    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

    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 Outcomes (1)

  • Physical activity enjoyment

    6 weeks

Study Arms (2)

Activa-Mente (Intervention)

EXPERIMENTAL

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.

Behavioral: Activa-Mente

Control group

NO INTERVENTION

This group of students will not be exposed to the intervention.

Interventions

Activa-MenteBEHAVIORAL

Active break program

Activa-Mente (Intervention)

Eligibility Criteria

Age8 Years - 10 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Facultad de Ciencias de la Actividad Física y del Deporte

Valparaíso, Chile

Location

Related Publications (2)

  • Reyes-Amigo T, Grao-Cruces A, Sanchez-Oliva D, Garcia-Hermoso A, Reyes-Molina D, Yanez-Sepulveda R, Olivares-Arancibia J, Hurtado-Almonacid J, Paez-Herrera J, Salinas-Gallardo G, Mendoza E, Ovalle-Fernandez C, Sepulveda-Figueroa F, Ibarra-Mora J. Acute effect of school-based active breaks on physical activity level and on-task classroom behavior in primary schoolchildren. Front Public Health. 2025 Oct 30;13:1644819. doi: 10.3389/fpubh.2025.1644819. eCollection 2025.

  • Reyes-Amigo T, Ibarra-Mora J, Aguilar-Farias N, Gomez-Alvarez N, Carrasco-Beltran H, Zapata-Lamana R, Hurtado-Almonacid J, Paez-Herrera J, Yanez-Sepulveda R, Cortes G, Rolle-Caceres G, Bezerra A. An active break program (ACTIVA-MENTE) at elementary schools in Chile: study protocol for a pilot cluster randomized controlled trial. Front Public Health. 2024 Jan 8;11:1243592. doi: 10.3389/fpubh.2023.1243592. eCollection 2023.

MeSH Terms

Conditions

Health BehaviorChild BehaviorMotor Activity

Condition Hierarchy (Ancestors)

Behavior

Study Officials

  • Tomas Reyes, PhD

    Playa Ancha University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Pilot cluster randomized controlled trial
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Phd

Study Record Dates

First Submitted

May 31, 2022

First Posted

June 3, 2022

Study Start

November 1, 2022

Primary Completion

October 20, 2023

Study Completion

April 30, 2024

Last Updated

January 2, 2024

Record last verified: 2023-12

Locations