Clinical trial NCT05602948: ACTIVE SCHOOL - Effects on Academic Performance of Novel Approaches to Increase Physical Activity in School-children
Official title: ACTIVE SCHOOL - Effects on Academic Performance of Novel Approaches to Increase Physical Activity in School-children
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Academic Performance
Keywords: Physical activity
Embodied cognition
Mathematics
Reading
Lead sponsor: University College Copenhagen
Sponsor class: OTHER
Collaborators: name: University of Copenhagen
name: UCL University College, Denmark
First posted: 2022-11-02
Enrollment: 1200
Sex: ALL
Minimum age (years): 8
Maximum age (years): 11
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The overall aim of ACTIVE SCHOOL is to investigate the effects of two different physical activity (PA) interventions on academic performance (AP), cognition, wellbeing, health and motivation. The two different approaches to PA in schools are based on;

1. 'Embodied cognition' focusing on fine and gross motor PA closely related and highly relevant to the learning task. 'Embodied cognition' builds upon theory suggesting that movement and performing actions leads to the construction of enhanced mental representations e.g. strengthening memory recall. This intervention is called 'MOVE \& LEARN'.
2. 'Exercise and cognition theory focusing mainly on gross motor movements (e.g. aerobic exercise) which is not relevant to the learning task and with no temporal connection to the learning task. The assumed positive effects are explained by physiological adaptations leading to changes in cognition, which potentially can affect AP. This intervention is called 'RUN, JUMP \& FUN'.

Based on this, the aims of ACTIVE SCHOOL are to develop two types of school-based PA interventions in close collaboration with the participating teachers, students and schools AND to investigate the effects of these two interventions on AP in a large school-based cluster-RCT with an intervention length of one school year.

The ACTIVE SCHOOL study consists of three phases: Phase 1) Development of the intervention, Phase 2) Pilot testing and, Pase 3) A three-armed randomized controlled trial (RCT). Participants will be students in 3rd grade (8-10 years-old) and their teachers/school pedagogues.

The development phase started in August 2021 and is still ongoing. The pilot study will run in September-November 2022 and the RCT from August 2023 to June 2024. In the RCT, schools will be randomly allocated to one of three intervention/control arms: 1) 'MOVE \& LEARN', 2) 'RUN, JUMP \& FUN' or 3) control. Primary and secondary outcomes will be collected before and after the intervention period to assess the intervention effects. Both the pilot and RCT study has been granted approval by the local ethics committee, and all rules from the Danish Data Protection Agency and GDPR will be followed. The RCT study will follow the Consolidated Standards of Reporting Trials (CONSORT) guidelines for RCT studies.


Eligibility criteria: Inclusion Criteria:

* Children in 3rd grade

Exclusion Criteria:

* Children with cognitive or physical disabilities hindering participation in the project activities

Primary outcomes:
measure: Mathematics performance by standardized national tests. Average of three domains (algebra, geometry, and basic mathematics skills)
timeFrame: Change from baseline Mathematics performance at 10 months
Secondary outcomes:
measure: Reading performance by standardized tests
timeFrame: Change from baseline reading performance at 10 months
measure: Executive functions measured by a digit span test and a spatial working memory test (SWM) which assess working memory and attention
timeFrame: Change from baseline executive function measures at 10 months
measure: Objective PA measurements by accelerometry for one week
timeFrame: Change from baseline objective PA measurements at 10 months
measure: Cardiorespiratory fitness using a validated modified shuttle run test
timeFrame: Change from baseline cardiorespiratory fitness at 10 months
measure: Anthropometry (stature, body mass, waist circumference and puberty status)
timeFrame: Change from baseline anthopometry measures at 10 months
measure: Register data on socioeconomic status (SES) and education of parents
timeFrame: Baseline
measure: Questionnaires (parental health, diseases diagnosed in the participating children, sleep, diet)
timeFrame: Baseline
measure: Questionnaire of quality of life
timeFrame: Change from baseline Kidscreen-27 at 10 months
measure: Questionnaire of intrinsic motivation and feeling of enjoyment, competence, autonomy and relatedness
timeFrame: Change from baseline Intrinsic Motivation Inventory at 10 months
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: University College Copenhagen
Study officials:
affiliation: University College Copenhagen
name: Anna Bugge, PhD
role: PRINCIPAL_INVESTIGATOR
References: