- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05602948
ACTIVE SCHOOL - Effects on Academic Performance of Novel Approaches to Increase Physical Activity in School-children
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;
- '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'.
- '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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Linn Damsgaard, PhD
- Phone Number: +4551632750
- Email: ldam@kp.dk
Study Contact Backup
- Name: Lise S Jeppesen
- Phone Number: +4540385510
- Email: lise.sohl@nexs.ku.dk
Study Locations
-
-
-
Copenhagen, Denmark, 2200
- Recruiting
- University College Copenhagen
-
Contact:
- Linn Damsgaard, PhD
- Phone Number: +4551632750
- Email: ldam@kp.dk
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Children in 3rd grade
Exclusion Criteria:
- Children with cognitive or physical disabilities hindering participation in the project activities
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: 'Run, Jump & Fun' intervention
The "Run, jump & fun" intervention consists of four 30 minutes sessions per week for one school year.
Activities are mostly conducted as whole class activities.
Head of schools and teachers/school pedagogues are involved in an initial intervention establishing process, guided by Active School personnel.
The aim is to create a local plan for the intervention tailored to the particular school.
Examples are "movement band", structured activities during recess with older students (13-15 years olds), etc. Activities are created to be fun, motivating and with moderate to high intensity PA.
|
The intervention can be designed e.g. to consist of morning sessions each schoolday (except days with PE) or with different time slots at different weekdays. Activities are mainly conducted by school personnel, but can be supplemented by activity sessions during recess once a week lead by older students. Further, to create variation and inspire teachers, external PA parties, for example instructors from local sports clubs are invited to conduct sessions for the students and deliver teaching materials. To align with the aim of the Danish school system, activities must have a pedagogical purpose. Both the "Run, jump & fun" and the "Move & learn" interventions have a set of strategies underpinning implementation (see Move & Learn" for more details). Both interventions will be grounded in Self-Determination Theory and all activities will be designed to be motivating and enjoyable for all children including those neither particularly fit nor enthusiastic about PA. |
|
Experimental: 'Move & Learn' intervention
This intervention is implemented as PA for 30 min in two Mathematics and two Danish lessons each week for one school year. Activities are conducted at whole-class level. The physical activities in "Move & Learn" are closely linked to the Mathematic curriculum and the Danish curriculum. The way the body is integrated in the learning task can vary. Examples are bodily or motor-skill demanding activities or less vigorous activities, e.g. standing up miming, using hand gestures or facial expressions. An important aspect of the interventions is that movements should be task relevant. The intervention is developed based on the embodied learning theory. |
The physical activities in "Move & Learn" are closely linked to the subject curricula. The bodily integrating in the learning task can vary between high bodily engagement and less demanding activities. Both the "Run, jump & fun" and the "Move & learn" interventions have a set of strategies underpinning implementation. These strategies include; 1) Initial workshops and follow-up courses for school personnel to ensure ownership, empowerment and knowledge in order to implement the interventions, 2) Teaching materials and resources, like posters, booklets etc., 3) A set of core principles for the two different interventions to ensure that the interventions are implemented as intended, and 4) Mandatory school meetings for staff and heads to ensure motivation. Both interventions will be grounded in Self-Determination Theory and all activities will be designed to be motivating and enjoyable for all children including those neither particularly fit nor enthusiastic about PA. |
|
No Intervention: Control
Control schools will continue their usual practice.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Mathematics performance by standardized national tests. Average of three domains (algebra, geometry, and basic mathematics skills)
Time Frame: Change from baseline Mathematics performance at 10 months
|
Danish National Test System.
The tests are computerized and composed in a progressive manner, depending on the individual child's performance, such that correct answers lead to more difficult subsequent questions, and incorrect answers lead to easier subsequent questions.
The final test result is therefore based on the level of difficulty, not the number of correct answers.
The tests are divided into three different domains; for mathematics: algebra, geometry, and basic mathematics skills.
No aids are permitted during the tests.
The tests are scored on a scale from 0 to 100 in each domain.
For this study, the mean of the three domains will be used for analyses
|
Change from baseline Mathematics performance at 10 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Reading performance by standardized tests
Time Frame: Change from baseline reading performance at 10 months
|
Hogrefe Psykologisk Forlag.
(2014).
|
Change from baseline reading performance at 10 months
|
|
Executive functions measured by a digit span test and a spatial working memory test (SWM) which assess working memory and attention
Time Frame: Change from baseline executive function measures at 10 months
|
WAIS-IV Administration and Scoring Manual.
San antonio, TX: Psychological Corporation (2008) and Spatial Working Memory (SWM) | Cambridge Cognition.
https://www.cambridgecognition.com/cantab/cognitive-tests/executive-function/spatial-executive-function-swm/.
|
Change from baseline executive function measures at 10 months
|
|
Objective PA measurements by accelerometry for one week
Time Frame: Change from baseline objective PA measurements at 10 months
|
ActiGraph GT3X+, LLC, Pensacola, Florida, USA
|
Change from baseline objective PA measurements at 10 months
|
|
Cardiorespiratory fitness using a validated modified shuttle run test
Time Frame: Change from baseline cardiorespiratory fitness at 10 months
|
Andersen, L. B., Andersen, T. E., Andersen, E. & Anderssen, S. A. An intermittent running test to estimate maximal oxygen uptake: the Andersen test.
J. Sport.
Med.
Phys.
Fit.
48, 434-437 (2008)
|
Change from baseline cardiorespiratory fitness at 10 months
|
|
Anthropometry (stature, body mass, waist circumference and puberty status)
Time Frame: Change from baseline anthopometry measures at 10 months
|
Tanner, J. M. Growth and maturation during adolescence.
Nutr.
Rev 39, 43-55 (1981).
|
Change from baseline anthopometry measures at 10 months
|
|
Register data on socioeconomic status (SES) and education of parents
Time Frame: Baseline
|
Danmarks_Statistik.
Data for research, Statistics Denmark.
Research data (2019
|
Baseline
|
|
Questionnaires (parental health, diseases diagnosed in the participating children, sleep, diet)
Time Frame: Baseline
|
Custom made
|
Baseline
|
|
Questionnaire of quality of life
Time Frame: Change from baseline Kidscreen-27 at 10 months
|
The KIDSCREEN-27 quality of life measure for children and adolescents: psychometric results from a cross-cultural survey in 13 European countries.
Quality of life research.
vol.
16 1347-1356 (2007).
|
Change from baseline Kidscreen-27 at 10 months
|
|
Questionnaire of intrinsic motivation and feeling of enjoyment, competence, autonomy and relatedness
Time Frame: Change from baseline Intrinsic Motivation Inventory at 10 months
|
Self-Determination.
Intrinsic Motivation Inventory.
|
Change from baseline Intrinsic Motivation Inventory at 10 months
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Anna Bugge, PhD, University College Copenhagen
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- Alias: 200511110
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Academic Performance
-
Mbarara University of Science and TechnologyUniversity of Calgary; Alberta Children's Hospital Research Institute; The ELMA... and other collaboratorsRecruiting
-
XIE HUIJUANEnrolling by invitationAcademic PerformanceChina
-
University of MoliseGiuseppe Calcagno; Giovanni Fiorilli; Andrea Buonsenso; Alessandra di CagnoCompletedAcademic Acheivement | Cognitive Performance | Physical PerformanceItaly
-
Prince Sattam Bin Abdulaziz UniversityCompletedAcademic PerformanceSaudi Arabia
-
University of WashingtonInstitute of Education SciencesUnknownEmotional/Behavioral Function | Academic PerformanceUnited States
-
University of South-Eastern NorwayCompletedPhysical Activity | Nutrition | Physical Fitness | Academic PerformanceNorway
-
Open UniversityNetherlands Organisation for Scientific Research; Aker Biomarine Antarctic AS; Omegametrix GmbH and other collaboratorsCompletedCognitive Function | Mental Health | Academic PerformanceNetherlands
-
Florida International UniversityNational Institute on Minority Health and Health Disparities (NIMHD)CompletedAnxiety | Academic PerformanceUnited States
-
University of SalamancaRecruitingStress | Anxiety | Academic PerformanceSpain
-
Raúl Sampieri CabreraCompletedStudents at Risk of Obtaining Low Academic PerformanceMexico
Clinical Trials on 'Run, Jump & Fun' intervention
-
Hebrew University of JerusalemMinistry of Health, IsraelRecruitingSubjective Cognitive Impairment | Subjective Cognitive Decline (SCD) | Subjective Memory ComplaintsIsrael
-
Hebrew University of JerusalemRecruitingSubjective Cognitive Decline (SCD)Israel
-
The University of Texas Medical Branch, GalvestonAmerican Heart AssociationCompletedObesity | Cardiovascular Disease | Diabetes | CancerUnited States
-
Pusan National UniversityCompletedPrehypertension | Blood Pressure | Adiposity | Abdominal Obesity
-
Tel Aviv UniversityCompletedDriving Risk Factors Among Adolescents With ADHDIsrael
-
University Hospital, MontpellierNot yet recruitingIdentification of Kinematic Variables Specific of Patellar Tendinopathy in Athletes at Risk (TENVOL)Knee Injuries | Jumper's Knee | Patellar Tendinitis | Musculoskeletal InjuriesFrance
-
Ludwig-Maximilians - University of MunichBeisheim Foundation (Germany)CompletedDepressive Disorder | Depression | Depressive Symptoms | Depressive Disorder, MajorGermany
-
Ludwig-Maximilians - University of MunichBeisheim Foundation (Germany)CompletedStress | Depressive Symptoms | Mental Health | Positive ThinkingGermany
-
Norther Private Collage of NursingCompletedNursing InterventionsSaudi Arabia, Egypt