Movement Integration in Primary Schools' Lessons

NCT ID: NCT05468216

Last Updated: 2022-11-09

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 700 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-09-01
• Study Completion Date: 2024-06-20

Brief Summary

The study assesses the effects of long-term movement integration intervention in academic lessons of primary education (6th grade) on physical activity levels and sedentary behaviour, executive functions, academic achievement and on-task behaviour. To achieve it, a cluster randomized controlled trial design will be adopted, where schools will be the clusters.

Detailed Description

The evidence shows that over 50% of Spanish children do not achieve the PA recommendations established by the WHO, and are therefore at higher risk of both short-term (e.g., overweight and obesity) and long-term health consequences (chronic illness in adolescence and adulthood). This is an alarming social and public health challenge in Spain and across Europe and effective solutions are needed.

Therefore, in this cluster randomized controlled trial, it will be tested if a long-term movement integration intervention in academic lessons (MovIn-Lessons) in primary education (specifically 6th grade) can increase the physical activity levels of children and reduce the sedentary behaviour at school-time. Additionally, it will be tested if this intervention can improve the executive functions, academic achievement and on-task behaviour.

Movement integration is defined as infusing physical activity, at any level of intensity, within general education classrooms during school time. Specifically, MovIn-Lessons intervention will consist of infusing physical activity in math, English and natural sciences lessons for all children attending the intervention schools. This will be achieved by carrying out learning activities in an active way.

Participants include children that are studying the 6th grade in primary education schools. Due to the cluster-randomized controlled trial design, the schools will be the clusters, and the design will have a restriction. The restriction is each cluster (school) that participates has to be from different towns or cities, even if schools are allocated to the same arm (intervention or control group). The aim of this restriction is to preserve construct validity by avoiding the fact that children from different schools in the same town or city could communicate with each other.

The recruitment will be following this procedure: all Catalan schools in the provinces of Barcelona and Girona will receive an invitation to participate in the study. Schools that are interested in taking part and meet the inclusion criteria will be eligible to participate. Schools will be randomly allocated to intervention or control group with matching. The matching criteria will be schools' characteristics (public or private, geographic location, sociodemographic profile and number of sixth grade classrooms) and teachers' characteristics (experience, confidence and pedagogical models used). Additionally, an allocation concealment mechanism will be used to prevent clusters' selection bias. All eligible participants will complete baseline assessments and follow-up evaluations conducted in the middle of the intervention (after three months), and one-week post-intervention.

Conditions

Physical Activity; Executive Function

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

MovIn-Lessons group

The schools which will implement the movement integration in the learning activities of primary education subjects (maths, natural science and English).

Group Type: EXPERIMENTAL

MovIn-Lessons group

Intervention Type: OTHER

The MovIn-Lessons intervention will consist of infusing PA in math, English and natural sciences lessons in primary education. The movement will be integrated in the learning activities for at least 20 minutes per session, at different physical intensities.

Control group

Schools which will continues applying the same methodology in the realization of the learning activities.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

MovIn-Lessons group

The MovIn-Lessons intervention will consist of infusing PA in math, English and natural sciences lessons in primary education. The movement will be integrated in the learning activities for at least 20 minutes per session, at different physical intensities.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• children in sixth grade of primary education

Exclusion Criteria

• children who require special educational needs and it is not following the whole-group classes

• Minimum Eligible Age: 11 Years
• Maximum Eligible Age: 12 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Vic - Central University of Catalonia

OTHER

Sponsor Role: lead

Responsible Party

Anna M. Señé Mir

PhD, Lecturer and researcher

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Anna M Señé Mir, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Vic- Central University of Vic

Locations

University of Vic- Central University of Catalonia

Vic, Barcelona, Spain

Countries

Spain

Central Contacts

Anna M Señé Mir, PhD

Role: CONTACT

annam.sene@uvic.cat

34938816164 ext. 1224

Anna M Señé Mir, PhD

Role: CONTACT

annam.sene@uvic.cat

Other Identifiers

MovIn

Identifier Type: -

Identifier Source: org_study_id