## Protocol Section
### Identification Module
**NCT ID:** NCT06423404

**Brief Title:** 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

#### Organization Study ID Info
**ID:** Universidad de Concepción
#### Organization
**Class:** OTHER
**Full Name:** Universidad de Concepcion
### Status Module
#### Completion Date
**Date:** 2024-08-30

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-21

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-15

**Overall Status:** ENROLLING_BY_INVITATION

#### Primary Completion Date
**Date:** 2024-08-30

**Type:** ESTIMATED

#### Start Date
**Date:** 2024-03-20

**Type:** ACTUAL

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-21
**Type:** ACTUAL
**Study First Submit Date:** 2024-04-15
**Study First Submit QC Date:** 2024-05-15
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Universidad de Concepcion

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** False

### Description Module

**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.

### Conditions Module

**Conditions:**

- Mental Health

- School-age Children

- School Health

**Keywords:**

- active break

- mental health

- school climate

- schoolchildren

- physical fitness

- multicentre randomized controlled trial

### Design Module

#### Design Info

**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).

##### Masking Info

**Masking:** DOUBLE

**Masking Description:** 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.

**Who Masked:**

- INVESTIGATOR

- OUTCOMES_ASSESSOR

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 700

**Type:** ESTIMATED

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

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

**Intervention Names:**

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

**Label:** Experimental Group: Active Break group

**Type:** EXPERIMENTAL

#### Arm Group 2

**Description:** 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.

**Intervention Names:**

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

**Label:** Control group: waiting list group

**Type:** OTHER

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Control group: waiting list group

- Experimental Group: Active Break group

**Description:** The \&#34;Active Classes + School Climate and Mental Health\&#34; 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

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

**Other Names:**

- active break program

**Type:** BEHAVIORAL

### Outcomes Module

#### Other Outcomes

**Description:** The sociodemographic instrument includes information related to characteristics of the students and their parents (i.e. economic level, educational level). In addition, physical activity and sedentary behavior, eating habits, sleeping and screen habits, type of transportation to the educational center.

**Measure:** Sociodemographic

**Time Frame:** From enrollment to the end of treatment at five months

#### Primary Outcomes

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

**Measure:** School climate

**Time Frame:** From enrollment to the end of treatment at five months

**Description:** 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.

**Measure:** Mental health

**Time Frame:** From enrollment to the end of treatment at five months

#### Secondary Outcomes

**Description:** The academic performance of the students will be measured using Integral Learning Diagnosis. For this study, only the reading test (2nd, 3rd, and 4th grades) and mathematics test (3rd and 4th grades) were used, measured at the beginning and end of the school year. The grading scale is from 1 as a minimum value to 7 as a maximum value.

**Measure:** Academic performance

**Time Frame:** From enrollment to the end of treatment at five months

**Description:** This outcome will be measurement using the Alpha Fitness Test battery protocol, which includes measurements of cardiorespiratory, musculoskeletal, and motor condition.

**Measure:** Physical health

**Time Frame:** From enrollment to the end of treatment at five months

### Eligibility Module

**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.

**Healthy Volunteers:** True

**Maximum Age:** 10 Years

**Minimum Age:** 6 Years

**Sex:** ALL

**Standard Ages:**

- CHILD

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Concepción

**Country:** Chile

**Facility:** Universidad de Concepción

**State:** Biobio

**Zip:** 4030000

**Location 2:**

**City:** Concepción

**Country:** Chile

**Facility:** Universidad de Concepción

**State:** Biobio

**Zip:** 4070371

### IPD Sharing Statement Module

**IPD Sharing:** UNDECIDED

### References Module

#### 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.

**PMID:** 38259740

## Derived Section

### Misc Info Module

- Version Holder: 2024-05-31
