Physical InactivityMOVEOUTNCT05237674
MOVEOUT: A Cluster RCT Investigating Education Outside the Classroom
A study testing The TEACHOUT intervention in people with Physical Inactivity and Psychological, run by University of Copenhagen at 3 sites in Denmark.
Trial summary
The purpose of this study is to investigate the efficacy of an education outside the classroom (EOtC) intervention on adolescents' physical activity, school motivation, academic achievement, and wellbeing. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Physical Inactivity, Psychological, Motivation
- What is being tested?
- The TEACHOUT intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 730 participants
- Where
- 3 sitesDenmark
- Study dates
- 23 Feb 2022to 27 Jun 2023
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Non-special need municipal primary and lower secondary school classes grade 4-10.
- Classes not involved in other school development or research projects.
- Participants for whom parents or legal guardians have provided written informed consent.
- Outcome data at baseline (for PA at least one time point; either winter or spring)
Who cannot join
- Classes not able to comply with the following will be excluded from per-protocol analysis, but will be included in the intention-to-treat analysis: intervention group classes should have a school-year average of >150 min of weekly EOtC and the control group classes should have a school-year average of <=150 min of weekly EOtC.
- Pupils with significant health problems as judged by the investigators based on parents or legal guardians report of child health status will be excluded from the analysis.
Trial locations and contacts
3 sites in 1 country.
Denmark3 sites
University of Copenhagen
Copenhagen, 2200
Steno Diabetes Center Copenhagen
Copenhagen, 2730
Center for Clinical Research and Prevention
Frederiksberg, Copenhagen, 2000
About this study
Official title: MOVEOUT: a Cluster RCT of the Efficacy, Mechanisms, and Mediation of an Education Outside the Classroom Intervention on Adolescents' Physical Activity.
The purpose of this study is to investigate the efficacy of an education outside the classroom (EOtC) intervention on adolescents' physical activity, school motivation, academic achievement, and wellbeing. The study will also investigate which pedagogical and didactical elements of EOtC are important to achieve more physical activity, school motivation, and wellbeing.
Read the detailed description
Globally, many children and adolescents are insufficiently physically active which increases the prevalence of non-communicable diseases and poor mental health over the lifecourse. Schools are an important setting to promote physical activity (PA) as children and adolescents spend a large proportion of their waking hours in this setting. The MOVEOUT study aims to increase school-based PA and wellbeing trough implementing regular practice of education outside the classroom (EOtC) during school hours. In EOtC, teachers relocate teaching and learning activities to places and settings outside the school building, e.g., urban and green space, societal institutions, and private companies, in agreement with curricular aims, content and obligations. The aim of EOtC is to promote pupils' learning and wellbeing through practical activities and the use of body and senses in authentic situations. Cross-sectional studies suggest that practice of EOtC is positively associated with more moderate-to-vigorous PA for boys, and more and light-intensity PA for girls. Quasi-experimental studies further demonstrate a positive effect of regular practice of EOtC on school motivation and wellbeing, without compromising academic performance. However, no studies have investigated the effect of EOtC on PA, school motivation, or wellbeing in a randomised controlled design. Furthermore, the specific pedagogical and didactical elements in EOtC sessions that promote PA, school motivation, and wellbeing have not been researched. Therefore, the aim of MOVEOUT is to study the effect on adolescents' PA, school motivation, and wellbeing and the mechanisms of EOtC that might promote PA, school motivation, and wellbeing in a randomised controlled design.
Compared to previous studies, the MOVEOUT study provides a methodologically improved and more robust evaluation. This study investigates the efficacy, mechanisms, and mediating effects of an EOtC intervention, The TEACHOUT Intervention[1], in a cluster randomised waitlist controlled trial with 15 intervention schools and 15 control schools. Schools will be required to have one or more classes grade 4-10 (pupils aged 10-16). The study will investigate which pedagogical and didactical elements of EOtC that are important to achieve more PA, school motivation, and wellbeing for 1) all adolescents, 2) adolescents at risk of becoming overweight, and 3) boys and girls separately. MOVEOUT will provide solid evidence of the effect of EOtC and supplement theory on EOtC pedagogy and didactics, which is needed in practice and policy to inform the already ongoing scale-up of EOtC, for instance in Northern European countries. The study is conducted in partnership between the applying institutions and the participating schools through all phases.
- Conditions
- Physical Inactivity, Psychological, Motivation, School Burnout
- Being tested
- The TEACHOUT intervention
- Keywords
- School, Physical activity, Outdoor, Motivation, Education, Pedagogy, Wellbeing, Health Promotion
- Medical subject headings
- Sedentary Behavior, Burnout, Psychological, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The TEACHOUT interventionBehavioural
The core component of the Intervention is a two-day training course on EOtC given to elementary school teachers followed by the teachers committing to apply EOtC for at least five hours a week, delivered in 1-2 weekly sessions for one school year (in this study, August 2022 to June 2023).
In the training course knowledge and understanding of the practice and theory of EOtC is facilitated in presentations and talks supplemented by illustrative examples in workshops and plenum discussions on local implementation. The 1-2 weekly EOtC sessions during the school year 2022-2023 may be delivered by one or more teachers simultaneously in various school subjects, at various places outside the school buildings.
| Study group | Role | What they receive |
|---|---|---|
| Intervention schools | Experimental | School children exposed to 1-2 weekly sessions, a total of at least five hours pr week, of education outside the classroom. Receives: Behavioral: The TEACHOUT intervention |
| Waiting control schools | No intervention | The waiting control schools will receive the two-day training course on EOtC one year later immediately after post measurements are conducted. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Physical Activity
Pupils' total daily time spent being sedentary, light, moderate and vigorous physically active and their daily time involved in running, walking, standing, sitting and lying will be measured with Axivity® AX3 accelerometers.
All acceleration data will be processed in Matlab (Version 9.9.0 R2020b, Mathworks Inc., Natick, Massachusetts, US) which includes resampling, generating ActiGraph counts2, identification of non-wear, and summarising the subjects' time spent in different intensity domains. Non-wear periods will be identified from both acceleration and temperature data. PA will be measured two times (winter and spring) before the intervention (baseline) and the same time two times towards the end of the intervention (endline) to account for the context dependency of PA to seasonal conditions. The effect of the TEACHOUT intervention on PA intensities and behaviours will be investigated across two timeframes, i.e., during school hours and full days.
Measured: 1 school year
School motivation
School motivation will be measured using the Academic Self-Regulation Questionnaire (called SRQ-A). The SRQ-A is a domain-specific self-report questionnaire developed for measuring the level of autonomy relative to doing different types of schoolwork among pupils in late primary and lower-secondary school.
Measured: 1 school year
Wellbeing
Wellbeing will be measured using two different scales: KIDSCREEN-27 and the pro-social behaviour scales of Strengths and Difficulties Questionnaire (SDQ). KIDSCREEN-27 measures the subjective health and wellbeing or health-related quality of life of children and adolescents aged 8-18. The pro-social behaviour scale of the SDQ measures social skills and competences of adolescents. Data on school absence will be collected as an objective indicator of wellbeing.
Measured: 1 school year
Reading competence
Reading competence will be measured with the validated age-adapted sentence reading test (Danish 'Sætningslæseprøve') by Hogrefe.
Measured: 1 school year
Mathematics skills
Math skills will be measured with the validated age-adapted mathematical basic test (MG test in Danish) by Hogrefe.
Measured: 1 school year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Feb 2022
- Study start23 Feb 2022
- Primary completion21 Jun 2023
- Study completion27 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Physical InactivityStudies of the same condition, open and under way.
- More trials run by University of CopenhagenThe sponsor's other registered studies.
- 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
- Fifteen of thirty municipal primary and lower secondary schools with one or more classes in grade 4-10 will be randomly assigned to the TEACHOUT intervention. Classes within the other 15 schools will act as controls and continue their teaching as usual. Teachers of the participating classes in the waitlisted control schools will be offered the intervention once the trial is finished.
- Masking
- None (open label)
- Enrolment
- 730 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Copenhagen
- Sponsor type
- University, hospital or other
- Collaborators
- Steno Diabetes Center Copenhagen, Center for Clinical Research and Prevention
- Responsible party
- Sponsor
- Investigators
- Glen Nielsen, PhD, Principal investigator, University of CopenhagenMads Bølling, PhD, Study director, Steno Diabetes Center CopenhagenPeter Elsborg, PhD, Study director, Center for Clinical Research and PreventionCharlotte D Klinker, PhD, Study chair, Steno Diabetes Center CopenhagenPeter Bentsen, PhD, Study chair, Center for Clinical Research and PreventionLærke M Grønfeldt, Msc, Study director, Center for Clinical Research and Prevention
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05237674
- Sponsor's protocol ID
- 2124712
- Acronym
- MOVEOUT
- Status last verified
- May 2024
- First submitted
- 19 Jan 2022
- Last updated
- 16 May 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Anonymised participant-level data can be made available upon reasonable request to the PI such as e.g. verification of the research results. To comply with the European General Data Protection Regulation, and to accommodate article 10 of the Danish Act on Data Protection anonymised participant-level data will be made available on the Open Science Framework five years after the main publication of this study.
Publications
Bolling M, Mygind L, Elsborg P, Melby PS, Barfod KS, Brond JC, Klinker CD, Nielsen G, Bentsen P. Efficacy and mechanisms of an education outside the classroom intervention on pupils' health and education: the MOVEOUT study protocol. BMC Public Health. 2023 Sep 19;23(1):1825. doi: 10.1186/s12889-023-16618-3.
PubMed 37726771
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- MOVEOUT: a Cluster RCT of the Efficacy, Mechanisms, and Mediation of an Education Outside the Classroom Intervention on Adolescents' Physical Activity.
- ClinicalTrials.gov ID
- NCT05237674
- Acronym / sponsor ID
- MOVEOUT / 2124712
- Conditions
- Physical Inactivity, Psychological, Motivation, School Burnout
- Keywords
- School, Physical activity, Outdoor, Motivation, Education, Pedagogy, Wellbeing, Health Promotion
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 730 participants (actual)
- Lead sponsor
- University of CopenhagenUniversity, hospital or other
- Collaborators
- Steno Diabetes Center Copenhagen, Center for Clinical Research and Prevention
- Study start
- 23 Feb 2022 (actual)
- Primary completion
- 21 Jun 2023 (actual)
- Study completion
- 27 Jun 2023 (actual)
- First posted
- 14 Feb 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 purpose of this study is to investigate the efficacy of an education outside the classroom (EOtC) intervention on adolescents' physical activity, school motivation, academic achievement, and wellbeing. The study will also investigate which pedagogical and didactical elements of EOtC are important to achieve more physical activity, school motivation, and wellbeing.
Detailed description
Globally, many children and adolescents are insufficiently physically active which increases the prevalence of non-communicable diseases and poor mental health over the lifecourse. Schools are an important setting to promote physical activity (PA) as children and adolescents spend a large proportion of their waking hours in this setting. The MOVEOUT study aims to increase school-based PA and wellbeing trough implementing regular practice of education outside the classroom (EOtC) during school hours. In EOtC, teachers relocate teaching and learning activities to places and settings outside the school building, e.g., urban and green space, societal institutions, and private companies, in agreement with curricular aims, content and obligations. The aim of EOtC is to promote pupils' learning and wellbeing through practical activities and the use of body and senses in authentic situations. Cross-sectional studies suggest that practice of EOtC is positively associated with more moderate-to-vigorous PA for boys, and more and light-intensity PA for girls. Quasi-experimental studies further demonstrate a positive effect of regular practice of EOtC on school motivation and wellbeing, without compromising academic performance. However, no studies have investigated the effect of EOtC on PA, school motivation, or wellbeing in a randomised controlled design. Furthermore, the specific pedagogical and didactical elements in EOtC sessions that promote PA, school motivation, and wellbeing have not been researched. Therefore, the aim of MOVEOUT is to study the effect on adolescents' PA, school motivation, and wellbeing and the mechanisms of EOtC that might promote PA, school motivation, and wellbeing in a randomised controlled design.
Compared to previous studies, the MOVEOUT study provides a methodologically improved and more robust evaluation. This study investigates the efficacy, mechanisms, and mediating effects of an EOtC intervention, The TEACHOUT Intervention[1], in a cluster randomised waitlist controlled trial with 15 intervention schools and 15 control schools. Schools will be required to have one or more classes grade 4-10 (pupils aged 10-16). The study will investigate which pedagogical and didactical elements of EOtC that are important to achieve more PA, school motivation, and wellbeing for 1) all adolescents, 2) adolescents at risk of becoming overweight, and 3) boys and girls separately. MOVEOUT will provide solid evidence of the effect of EOtC and supplement theory on EOtC pedagogy and didactics, which is needed in practice and policy to inform the already ongoing scale-up of EOtC, for instance in Northern European countries. The study is conducted in partnership between the applying institutions and the participating schools through all phases.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Fifteen of thirty municipal primary and lower secondary schools with one or more classes in grade 4-10 will be randomly assigned to the TEACHOUT intervention. Classes within the other 15 schools will act as controls and continue their teaching as usual. Teachers of the participating classes in the waitlisted control schools will be offered the intervention once the trial is finished.
| Arm | Type | Receives |
|---|---|---|
| Intervention schools | Experimental | Behavioral: The TEACHOUT interventionSchool children exposed to 1-2 weekly sessions, a total of at least five hours pr week, of education outside the classroom. |
| Waiting control schools | No intervention | –The waiting control schools will receive the two-day training course on EOtC one year later immediately after post measurements are conducted. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Non-special need municipal primary and lower secondary school classes grade 4-10.
- Classes not involved in other school development or research projects.
- Participants for whom parents or legal guardians have provided written informed consent.
- Outcome data at baseline (for PA at least one time point; either winter or spring)
Key exclusion criteria (2 listed)
- Classes not able to comply with the following will be excluded from per-protocol analysis, but will be included in the intention-to-treat analysis: intervention group classes should have a school-year average of >150 min of weekly EOtC and the control group classes should have a school-year average of <=150 min of weekly EOtC.
- Pupils with significant health problems as judged by the investigators based on parents or legal guardians report of child health status will be excluded from the analysis.
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 |
|---|---|---|
| The TEACHOUT interventionThe core component of the Intervention is a two-day training course on EOtC given to elementary school teachers followed by the teachers committing to apply EOtC for at least five hours a week, delivered in 1-2 weekly sessions for one school year (in this study, August 2022 to June 2023). In the training course knowledge and understanding of the practice and theory of EOtC is facilitated in presentations and talks supplemented by illustrative examples in workshops and plenum discussions on local implementation. The 1-2 weekly EOtC sessions during the school year 2022-2023 may be delivered by one or more teachers simultaneously in various school subjects, at various places outside the school buildings. | Behavioural | Intervention schools |
Primary outcome
Physical Activity
Time frame: 1 school year
Pupils' total daily time spent being sedentary, light, moderate and vigorous physically active and their daily time involved in running, walking, standing, sitting and lying will be measured with Axivity® AX3 accelerometers. All acceleration data will be processed in Matlab (Version 9.9.0 R2020b, Mathworks Inc., Natick, Massachusetts, US) which includes resampling, generating ActiGraph counts2, identification of non-wear, and summarising the subjects' time spent in different intensity domains. Non-wear periods will be identified from both acceleration and temperature data. PA will be measured two times (winter and spring) before the intervention (baseline) and the same time two times towards the end of the intervention (endline) to account for the context dependency of PA to seasonal conditions. The effect of the TEACHOUT intervention on PA intensities and behaviours will be investigated across two timeframes, i.e., during school hours and full days.
School motivation
Time frame: 1 school year
School motivation will be measured using the Academic Self-Regulation Questionnaire (called SRQ-A). The SRQ-A is a domain-specific self-report questionnaire developed for measuring the level of autonomy relative to doing different types of schoolwork among pupils in late primary and lower-secondary school.
Wellbeing
Time frame: 1 school year
Wellbeing will be measured using two different scales: KIDSCREEN-27 and the pro-social behaviour scales of Strengths and Difficulties Questionnaire (SDQ). KIDSCREEN-27 measures the subjective health and wellbeing or health-related quality of life of children and adolescents aged 8-18. The pro-social behaviour scale of the SDQ measures social skills and competences of adolescents. Data on school absence will be collected as an objective indicator of wellbeing.
Reading competence
Time frame: 1 school year
Reading competence will be measured with the validated age-adapted sentence reading test (Danish 'Sætningslæseprøve') by Hogrefe.
Mathematics skills
Time frame: 1 school year
Math skills will be measured with the validated age-adapted mathematical basic test (MG test in Danish) by Hogrefe.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 May 2024.
- Derived from this study: PubMed 37726771Bolling M, Mygind L, Elsborg P, Melby PS, Barfod KS, Brond JC, Klinker CD, Nielsen G, Bentsen P. Efficacy and mechanisms of an education outside the classroom intervention on pupils' health and education: the MOVEOUT study protocol. BMC Public Health. 2023 Sep 19;23(1):1825. doi: 10.1186/s12889-023-16618-3.
- Individual participant dataSharing planned: Yes. Anonymised participant-level data can be made available upon reasonable request to the PI such as e.g. verification of the research results. To comply with the European General Data Protection Regulation, and to accommodate article 10 of the Danish Act on Data Protection anonymised participant-level data will be made available on the Open Science Framework five years after the main publication of this study.
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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.
Glen Nielsen, PhD principal investigator
University of Copenhagen
Mads Bølling, PhD study director
Steno Diabetes Center Copenhagen
Peter Elsborg, PhD study director
Center for Clinical Research and Prevention
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing The TEACHOUT intervention in people with Physical Inactivity and Psychological, run by University of Copenhagen at 3 sites in Denmark.
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 4 inclusion and 2 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: finished, as of the sponsor's last update on 16 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Denmark. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Physical Activity (time frame: 1 school year). 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?
On the ClinicalTrials.gov record for NCT05237674, which also lists 1 linked publication.
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 16 May 2024.