Physical ActivityMovIn-LessonsNCT05468216
Movement Integration in Primary Schools' Lessons
A study testing MovIn-Lessons group in people with Physical Activity and Executive Function, run by University of Vic - Central University of Catalonia at 1 site in Spain.
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. Read more about this study
- Who is it for?
- Ages 11 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Physical Activity, Executive Function
- What is being tested?
- MovIn-Lessons group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 700 participants
- Where
- 1 siteSpain
- Study dates
- 1 Sep 2023to 20 Jun 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 11 to 12 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- children in sixth grade of primary education
Who cannot join
- children who require special educational needs and it is not following the whole-group classes
Trial locations and contacts
1 site in 1 country.
Anna M Señé Mir, PhD contact
Spain1 site
University of Vic- Central University of Catalonia
Vic, Barcelona, 08500
About this study
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
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.
Read the 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
- Being tested
- MovIn-Lessons group
- Keywords
- exercise, education, sedentary behaviour, movement integration, executive functions, academic performance
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MovIn-Lessons groupOther
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.
| Study group | Role | What they receive |
|---|---|---|
| MovIn-Lessons group | Experimental | The schools which will implement the movement integration in the learning activities of primary education subjects (maths, natural science and English). Receives: Other: MovIn-Lessons group |
| Control group | No intervention | Schools which will continues applying the same methodology in the realization of the learning activities. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, 8 weeks after starting intervention, end of the intervention (after 16 weeks)
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.
Measured: Baseline, 8 weeks after starting intervention, end of the intervention (after 16 weeks).
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.
Measured: Baseline, 8 weeks after starting intervention, end of the intervention (after 16 weeks)
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).
Measured: Baseline, and end of the intervention (after 16 weeks)
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.
Measured: Baseline, 8 weeks after starting intervention, end of the intervention (after 16 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2022
- Study start1 Sep 2023 (estimated)
- Primary completion2 Jun 2024 (estimated)
- Study completion20 Jun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Physical ActivityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized Controlled Trial
- Masking
- None (open label)
- Enrolment
- 700 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Vic - Central University of Catalonia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Anna M. Señé Mir, University of Vic - Central University of Catalonia
- Investigators
- Anna M Señé Mir, PhD, Principal investigator, University of Vic- Central University of Vic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05468216
- Sponsor's protocol ID
- MovIn
- Acronym
- MovIn-Lessons
- Status last verified
- Nov 2022
- First submitted
- 9 May 2022
- Last updated
- 9 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05468216
- Acronym / sponsor ID
- MovIn-Lessons / MovIn
- Conditions
- Physical Activity, Executive Function
- Keywords
- exercise, education, sedentary behaviour, movement integration, executive functions, academic performance
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 700 participants (estimated)
- Lead sponsor
- University of Vic - Central University of CataloniaUniversity, hospital or other
- Study start
- 1 Sep 2023 (estimated)
- Primary completion
- 2 Jun 2024 (estimated)
- Study completion
- 20 Jun 2024 (estimated)
- First posted
- 21 Jul 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomized Controlled Trial
| Arm | Type | Receives |
|---|---|---|
| MovIn-Lessons group | Experimental | Other: MovIn-Lessons groupThe schools which will implement the movement integration in the learning activities of primary education subjects (maths, natural science and English). |
| Control group | No intervention | –Schools which will continues applying the same methodology in the realization of the learning activities. |
Who may qualify
- Ages
- 11 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- children in sixth grade of primary education
Key exclusion criteria (1 listed)
- children who require special educational needs and it is not following the whole-group classes
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MovIn-Lessons groupThe 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. | Other | MovIn-Lessons group |
Primary outcome
Physical activity measures change: time and intensity
Time frame: Baseline, 8 weeks after starting intervention, end of the intervention (after 16 weeks)
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.
Sedentary behaviour measures change: time
Time frame: Baseline, 8 weeks after starting intervention, end of the intervention (after 16 weeks).
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.
Executive functions measures change
Time frame: Baseline, 8 weeks after starting intervention, end of the intervention (after 16 weeks)
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.
Academic achievement measures change
Time frame: Baseline, and end of the intervention (after 16 weeks)
The Catalan national standardized test consists of evaluating the degree of achievement of basic competences at the end of primary education (sixth grade).
On-task behaviour measures change
Time frame: Baseline, 8 weeks after starting intervention, end of the intervention (after 16 weeks)
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Nov 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anna M Señé Mir, PhD contact
Anna M Señé Mir, PhD principal investigator
University of Vic- Central University of Vic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MovIn-Lessons group in people with Physical Activity and Executive Function, run by University of Vic - Central University of Catalonia at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Anna M Señé Mir, PhD (34938816164 ext. 1224, annam.sene@uvic.cat), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Physical activity measures change: time and intensity (time frame: Baseline, 8 weeks after starting intervention, end of the intervention (after 16 weeks)). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Nov 2022.