NCT06423404

Brief Summary

Background: The incidence of mental health issues in children is increasing worldwide. In Chile, a recent surge in reports of deteriorating mental health among school populations and an increase in complaints related to poor school climate have been observed. Physical activity, specifically active breaks in the classroom, has shown positive effects on children's health. However, evidence regarding its impact on mental health and school climate in children is limited. Objective: This article outlines the design, measurements, intervention program, and potential efficacy of the Active Classes + School Climate and Mental Health project. This project will assess a 12-week program of active breaks through guided videos with curricular content in the school classroom, and its effects on mental health and school climate as its primary contributions. Additionally, it will measure physical activity, physical fitness, motor competence, and academic performance in students aged 6 to 10 years in the Biobío province, Chile, as secondary contributions. Methodology: It will be performed a multicenter randomized controlled trial involving students in the 1st to 4th grade (6 to 10 years old), encompassing a total of 48 classes across six schools (three intervention and three control) in the Biobío region, Chile. Video-guided active breaks will be implemented through the Active Classes; web platform, featuring curricular content, lasting 5 to 10 minutes and of moderate to vigorous intensity physical activity, twice a day, Monday to Friday, over a span of 12 weeks. Expected Results/Discussion: To our knowledge, this will be the first study in Chile to evaluate the effects of incorporating video-guided active breaks with curricular content on mental health variables and school climate in schoolchildren. Thus, this study contributes to the scarce evidence on the effects of video-guided active breaks on mental health variables and school climate in schoolchildren worldwide. Additionally, it will provide crucial information about active teaching methodologies that have the potential to positively contribute to the well-being of students, thus addressing the problems of mental health and climate in Chilean schools.

Trial Health

55
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
700

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

2 active sites

Status
enrolling by invitation

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

Study Start

First participant enrolled

March 20, 2024

Completed
26 days until next milestone

First Submitted

Initial submission to the registry

April 15, 2024

Completed
1 month until next milestone

First Posted

Study publicly available on registry

May 21, 2024

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 30, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 30, 2024

Completed
Last Updated

May 21, 2024

Status Verified

May 1, 2024

Enrollment Period

5 months

First QC Date

April 15, 2024

Last Update Submit

May 15, 2024

Conditions

Keywords

active breakmental healthschool climateschoolchildrenphysical fitnessmulticentre randomized controlled trial

Outcome Measures

Primary Outcomes (2)

  • School climate

    School climate scale (ECLIS). 82 items with a four-level Likert-type response format (ranging from all to none).

    From enrollment to the end of treatment at five months

  • Mental health

    This outcome will be measurement with School Self-Esteem Test (SSET) and Self-report of socioemotional well-being. The raw score sum is transformed into a T score according to age norms, categorizing students as follows: normal self-esteem, ≥ 40 points; low self-esteem, 30-39 points; and very low self-esteem, ≤ 29 points.

    From enrollment to the end of treatment at five months

Secondary Outcomes (2)

  • Academic performance

    From enrollment to the end of treatment at five months

  • Physical health

    From enrollment to the end of treatment at five months

Other Outcomes (1)

  • Sociodemographic

    From enrollment to the end of treatment at five months

Study Arms (2)

Experimental Group: Active Break group

EXPERIMENTAL

The Experimental Group, receiving a 12-week program of video-guided active breaks with curricular content in the school classroom

Behavioral: the Experimental Group, receiving a 12-week program of video-guided active breaks with curricular content in the school classroom

Control group: waiting list group

OTHER

The Control Group, receiving the same intervention as the experimental group after the final data collection. During the time of the intervention, the waiting list group will receive the usual classes.

Behavioral: the Experimental Group, receiving a 12-week program of video-guided active breaks with curricular content in the school classroom

Interventions

The \"Active Classes + School Climate and Mental Health\" program was crafted following a comprehensive review by the research team on active breaks in the child school population. Based on the findings of this review, the optimal type and duration of intervention, frequency and intensity of the most effective exercises, and video-guided modalities with curricular content for active breaks will be established. Subsequently, a collaborative network was formed, involving researchers from education, sports science, social sciences, medicine, primary school teachers within the Chilean public school system, teams of educational leaders, parents, guardians, pedagogy students, and graduate students. The purpose was to create a team that systematically supports the development of various stages of the project from a multi and interdisciplinary perspective

Also known as: active break program
Control group: waiting list groupExperimental Group: Active Break group

Eligibility Criteria

Age6 Years - 10 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • \- a) Regular male or female students in primary education, from first to fourth grade, at a public school in one of the three provinces of the Biobío region, willing to participate and with parental consent.
  • b) Students spend at least 38 hours per week in classes (6.5 hours daily) and have at least two short breaks (10-15 minutes) per day.

You may not qualify if:

  • a) Students with a medical diagnosis of spinal pathologies, vertigo, or uncontrolled hypertension.
  • b) Students with severe intellectual disabilities prevented them from following the program instructions.
  • c) Students participating simultaneously in another project with similar objectives.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Universidad de Concepción

Concepción, Región del Biobío, 4030000, Chile

Location

Universidad de Concepción

Concepción, Región del Biobío, 4070371, Chile

Location

Related Publications (3)

  • 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.

    PMID: 38259740BACKGROUND
  • Robles-Campos A, Reyes-Molina D, Kracht-Suazo K, Cigarroa I, Carcamo-Oyarzun J, Martinez-Lopez N, Perez-Ruiz M, Grao-Cruces A, Mota J, Ruiz-Ariza A, Munoz Hinrichsen F, Garcia-Perez-de-Sevilla G, Celis-Morales C, Zapata-Lamana R. Effects of Video-Guided Active Breaks on Motor Competence of Schoolchildren with Special Education Needs. Children (Basel). 2025 Jun 21;12(7):820. doi: 10.3390/children12070820.

  • Zapata-Lamana R, Robles-Campos A, Reyes-Molina D, Rojas-Bravo J, Salcedo Lagos P, Chavez-Castillo Y, Gajardo-Aguayo J, Villalobos JV, Arias AM, Sanhueza-Campos C, Ibarra Mora J, Reyes-Amigo T, Cristi-Montero C, Sanchez-Oliva D, Ruiz-Hermosa A, Sanchez-Lopez M, Poblete-Valderrama F, Celis-Morales C, Martorell M, Carrasco-Marin F, Albornoz-Guerrero J, Parra-Rizo MA, Cigarroa I. Effects of video-guided active breaks with curricular content on mental health and classroom climate in chilean schoolchildren aged 6 to 10: study protocol for a multicentre randomized controlled trial. Front Physiol. 2024 Sep 12;15:1438555. doi: 10.3389/fphys.2024.1438555. eCollection 2024.

MeSH Terms

Conditions

Psychological Well-Being

Condition Hierarchy (Ancestors)

Personal SatisfactionBehavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
After schools agreed to participate, they were randomly assigned using a sequence generated by the IBM SPSS statistical package, with concealed allocation to one of two groups: 1) the Experimental Group (n=3), receiving a 12-week program of video-guided active breaks with curricular content in the school classroom; and 2) the Control Group (n=3), receiving the same intervention as the experimental group after the final data collection. A simple stratified randomization sequence by sex was used to achieve balance between males and females in both groups. The randomization sequence will be concealed through sequentially numbered, opaque, sealed envelopes, conduct by a project investigator with no contact with schools and participants. Significant differences in the quality of life, motor skills, and academic performance have been found in studies with similar samples.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: The project involves public primary schools with similar indices of school vulnerability (SVI) and medium to low socioeconomic status in the Biobío province, Chile. This selection was made because students attending these schools spend approximately eight hours per day (from 8:00 AM to 4:00 PM) with two 30-minute breaks and a longer one-hour lunch break. The intervention will focus on 1st to 4th grade classes. Six schools (three treatments and three controls) were recruited, estimating a sample size of 700 students (six schools × eight classes, with each class having 30 to 40 students).
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 15, 2024

First Posted

May 21, 2024

Study Start

March 20, 2024

Primary Completion

August 30, 2024

Study Completion

August 30, 2024

Last Updated

May 21, 2024

Record last verified: 2024-05

Locations