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Movement Integration in Primary Schools' Lessons (MovIn-Lessons)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05468216
Recruitment Status : Not yet recruiting
First Posted : July 21, 2022
Last Update Posted : July 21, 2022
Sponsor:
Information provided by (Responsible Party):
Anna M. Señé Mir, University of Vic - Central University of Catalonia

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.

Condition or disease Intervention/treatment Phase
Physical Activity Executive Function Other: MovIn-Lessons group Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 700 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Randomized Controlled Trial
Masking: None (Open Label)
Masking Description: Only an allocation concealment mechanism will be used to prevent clusters' selection bias
Primary Purpose: Prevention
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
Estimated Study Start Date : September 1, 2022
Estimated Primary Completion Date : June 2, 2023
Estimated Study Completion Date : June 20, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Health Checkup

Arm Intervention/treatment
Experimental: MovIn-Lessons group
The schools which will implement the movement integration in the learning activities of primary education subjects (maths, natural science and English).
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.

No Intervention: Control group
Schools which will continues applying the same methodology in the realization of the learning activities.



Primary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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).

  5. 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.


Other Outcome Measures:
  1. Socioeconomic status [ Time Frame: Baseline ]
    (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.

  2. General Physical activity levels [ Time Frame: Baseline ]
    (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.

  3. Body Mass Index [ Time Frame: Baseline ]
    (confounding variable)



Information from the National Library of Medicine

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Ages Eligible for Study:   11 Years to 12 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05468216


Contacts
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Contact: Anna M Señé Mir, PhD 34938816164 ext 1224 annam.sene@uvic.cat
Contact: Anna M Señé Mir, PhD annam.sene@uvic.cat

Locations
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Spain
University of Vic- Central University of Catalonia
Vic, Barcelona, Spain, 08500
Sponsors and Collaborators
University of Vic - Central University of Catalonia
Investigators
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Principal Investigator: Anna M Señé Mir, PhD University of Vic- Central University of Vic
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Responsible Party: Anna M. Señé Mir, PhD, Lecturer and researcher, University of Vic - Central University of Catalonia
ClinicalTrials.gov Identifier: NCT05468216    
Other Study ID Numbers: MovIn
First Posted: July 21, 2022    Key Record Dates
Last Update Posted: July 21, 2022
Last Verified: July 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Anna M. Señé Mir, University of Vic - Central University of Catalonia:
exercise
education
sedentary behaviour
movement integration
executive functions
academic performance