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MOVEOUT: A Cluster RCT Investigating Education Outside the Classroom (MOVEOUT)

Primary Purpose

Physical Inactivity, Psychological, Motivation

Status
Active
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
The TEACHOUT intervention
Sponsored by
University of Copenhagen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Physical Inactivity focused on measuring School, Physical activity, Outdoor, Motivation, Education, Pedagogy, Wellbeing, Health Promotion

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria

  • 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)

Exclusion Criteria

  • 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.

Sites / Locations

  • Center for Clinical Research and Prevention
  • University of Copenhagen
  • Steno Diabetes Center Copenhagen

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Intervention schools

Waiting control schools

Arm Description

School children exposed to 1-2 weekly sessions, a total of at least five hours pr week, of education outside the classroom.

The waiting control schools will receive the two-day training course on EOtC one year later immediately after post measurements are conducted.

Outcomes

Primary Outcome Measures

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.
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.
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.
Reading competence
Reading competence will be measured with the validated age-adapted sentence reading test (Danish 'Sætningslæseprøve') by Hogrefe.
Mathematics skills
Math skills will be measured with the validated age-adapted mathematical basic test (MG test in Danish) by Hogrefe.

Secondary Outcome Measures

Full Information

First Posted
January 19, 2022
Last Updated
November 22, 2022
Sponsor
University of Copenhagen
Collaborators
Steno Diabetes Center Copenhagen, Center for Clinical Research and Prevention
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1. Study Identification

Unique Protocol Identification Number
NCT05237674
Brief Title
MOVEOUT: A Cluster RCT Investigating Education Outside the Classroom
Acronym
MOVEOUT
Official Title
MOVEOUT: a Cluster RCT of the Efficacy, Mechanisms, and Mediation of an Education Outside the Classroom Intervention on Adolescents' Physical Activity.
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
February 23, 2022 (Actual)
Primary Completion Date
June 1, 2023 (Anticipated)
Study Completion Date
June 1, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Copenhagen
Collaborators
Steno Diabetes Center Copenhagen, Center for Clinical Research and Prevention

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Physical Inactivity, Psychological, Motivation, School Burnout
Keywords
School, Physical activity, Outdoor, Motivation, Education, Pedagogy, Wellbeing, Health Promotion

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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)
Allocation
Randomized
Enrollment
730 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention schools
Arm Type
Experimental
Arm Description
School children exposed to 1-2 weekly sessions, a total of at least five hours pr week, of education outside the classroom.
Arm Title
Waiting control schools
Arm Type
No Intervention
Arm Description
The waiting control schools will receive the two-day training course on EOtC one year later immediately after post measurements are conducted.
Intervention Type
Behavioral
Intervention Name(s)
The TEACHOUT intervention
Intervention Description
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.
Primary Outcome Measure Information:
Title
Physical Activity
Description
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.
Time Frame
1 school year
Title
School motivation
Description
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.
Time Frame
1 school year
Title
Wellbeing
Description
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.
Time Frame
1 school year
Title
Reading competence
Description
Reading competence will be measured with the validated age-adapted sentence reading test (Danish 'Sætningslæseprøve') by Hogrefe.
Time Frame
1 school year
Title
Mathematics skills
Description
Math skills will be measured with the validated age-adapted mathematical basic test (MG test in Danish) by Hogrefe.
Time Frame
1 school year

10. Eligibility

Sex
All
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria 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) Exclusion Criteria 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Glen Nielsen, PhD
Organizational Affiliation
University of Copenhagen
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Mads Bølling, PhD
Organizational Affiliation
Steno Diabetes Center Copenhagen
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Peter Elsborg, PhD
Organizational Affiliation
Center for Clinical Research and Prevention
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Charlotte Demant Klinker, PhD
Organizational Affiliation
Steno Diabetes Center Copenhagen
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Peter Bentsen, PhD
Organizational Affiliation
Center for Clinical Research and Prevention
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Lærke Mygind Grønfeldt, Msc
Organizational Affiliation
Center for Clinical Research and Prevention
Official's Role
Study Director
Facility Information:
Facility Name
Center for Clinical Research and Prevention
City
Frederiksberg
State/Province
Copenhagen
ZIP/Postal Code
2000
Country
Denmark
Facility Name
University of Copenhagen
City
Copenhagen
ZIP/Postal Code
2200
Country
Denmark
Facility Name
Steno Diabetes Center Copenhagen
City
Copenhagen
ZIP/Postal Code
2730
Country
Denmark

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
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.
IPD Sharing Time Frame
Anonymised participant-level data will be made available on the Open Science Framework five years after the main publication of this study. Statistical plan, study protocol and analytical code will be made available in the osf folder upon acceptance of first preregistered manuscript.
IPD Sharing Access Criteria
Data can be made available upon reasonable request to the PI such as e.g. verification of the research results.
IPD Sharing URL
https://osf.io/89pmf/?view_only=298a0d461e594bc3b2d73ace8d107882

Learn more about this trial

MOVEOUT: A Cluster RCT Investigating Education Outside the Classroom

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