Clinical trial NCT06423404: Active Breaks on Mental Health and Classroom Climate in Chilean Schoolchildren Aged 6 to 10
Official title: 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
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Mental Health
School-age Children
School Health
Keywords: active break
mental health
school climate
schoolchildren
physical fitness
multicentre randomized controlled trial
Lead sponsor: Universidad de Concepcion
Sponsor class: OTHER
First posted: 2024-05-21
Enrollment: 700
Sex: ALL
Minimum age (years): 6
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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).
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

- 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: School climate
timeFrame: From enrollment to the end of treatment at five months
measure: Mental health
timeFrame: From enrollment to the end of treatment at five months
Secondary outcomes:
measure: Academic performance
timeFrame: From enrollment to the end of treatment at five months
measure: Physical health
timeFrame: From enrollment to the end of treatment at five months
Other outcomes:
measure: Sociodemographic
timeFrame: From enrollment to the end of treatment at five months
Locations:
city: Concepción
country: Chile
facility: Universidad de Concepción
state: Biobio
city: Concepción
country: Chile
facility: Universidad de Concepción
state: Biobio
Study officials:
References:
citation: 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.