Movement Integration in Primary Schools' Lessons

Physical Activity Clinical Trial

— MovIn-Lessons  

Official title:

The Effect of MovIn-Lessons Project on Physical Activity Levels, Executive Functions, Academic Performance and On-task Behaviour in Primary Schools: Study Protocol for a Cluster-randomized Controlled Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05468216
• Other study ID #: MovIn
• Status: Not yet recruiting
• Phase: N/A
• Start date: September 1, 2023
• Est. completion date: June 20, 2024

Study information

• Verified date: November 2022
• Source: University of Vic - Central University of Catalonia
• Contact: Anna M Señé Mir, PhD
• Phone: 34938816164
• Email: annam.sene[@]uvic.cat
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 700
• Est. completion date: June 20, 2024
• Est. primary completion date: June 2, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 11 Years to 12 Years

Eligibility

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

Related Conditions & MeSH terms

• Executive Function
• Physical Activity

Intervention

Other:
• 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.

Locations

Country	Name	City	State
Spain	University of Vic- Central University of Catalonia	Vic	Barcelona

Sponsors (1)

Lead Sponsor	Collaborator
University of Vic - Central University of Catalonia

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Socioeconomic status	(confounding variable) The Family Affluence Scale II (FAS II) consists of four questions asking children aspects they are likely to know about their family. FAS II low (score=0,1,2) indicates low affluence, FAS II medium (score=3,4,5) indicates middle affluence, and FAS II high (score=6,7,8,9) indicates high affluence. Therefore 0 is the minimum value and 9 the maximum value.	Baseline
Other	General Physical activity levels	(confounding variable) The Physical Activity Questionnaire for Children (PAQ-C) assesses the general physical activity level in the last seven days. It is a self-administered recall questionnaire.	Baseline
Other	Body Mass Index	(confounding variable)	Baseline
Primary	Physical activity measures change: time and intensity	Accelerometers will be used to measure and quantify the physical activity levels of students. Accelerometers have already been demonstrated as a valid and objective measure to quantify body posture and activity patterns during free-living conditions in children and adults.	Baseline, 8 weeks after starting intervention, end of the intervention (after 16 weeks)
Primary	Sedentary behaviour measures change: time	Accelerometers will be used to measure and quantify sedentary behaviour of students. Accelerometers have already been demonstrated as a valid and objective measure to quantify body posture and activity patterns during free-living conditions in children and adults.	Baseline, 8 weeks after starting intervention, end of the intervention (after 16 weeks).
Primary	Executive functions measures change	Three core EFs will be assessed with validated tests from the NIH toolbox battery for the population aged between 3 and 85 years old. Inhibition control and attention: Flanker Inhibitory Control and Attention test; Working memory: List Sorting Working Memory test; Cognitive flexibility: Dimensional Change Card Sort test.	Baseline, 8 weeks after starting intervention, end of the intervention (after 16 weeks)
Primary	Academic achievement measures change	The Catalan national standardized test consists of evaluating the degree of achievement of basic competences at the end of primary education (sixth grade).	Baseline, and end of the intervention (after 16 weeks)
Primary	On-task behaviour measures change	The Direct Behaviour Rating Scale assesses students' behaviour and engagement by rating the percentage of time that the student does the desired behaviour. High scores on the Direct Behavior Rating scales (Academically engaged, Respectful and Disruptive) indicate high levels, with 10 being the maximum value. On the other hand, low scores on the Direct Behavior Rating scales (Academically engaged, Respectful and Disruptive) indicate low levels, with 0 being the minimum value.	Baseline, 8 weeks after starting intervention, end of the intervention (after 16 weeks)