MOVEOUT: A Cluster RCT Investigating Education Outside the Classroom

NCT05237674 | Completed DMC

• 1 other identifier: 2124712
• Study Type: interventional
• Target: 730
• Locations: 1 country
• Sites: 3

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.

Conditions

Physical Inactivity; Psychological; Motivation; School Burnout

Keywords

School; Physical activity; Outdoor; Motivation; Education; Pedagogy; Wellbeing; Health Promotion

Outcome Measures

Primary Outcomes (5)

• 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.

  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.

  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.

  1 school year

• Reading competence

  Reading competence will be measured with the validated age-adapted sentence reading test (Danish 'Sætningslæseprøve') by Hogrefe.

  1 school year

• Mathematics skills

  Math skills will be measured with the validated age-adapted mathematical basic test (MG test in Danish) by Hogrefe.

  1 school year

Study Arms (2)

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.

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.

Interventions

The TEACHOUT intervention BEHAVIORAL

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.

Intervention schools

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

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

Study Sites (3)

Center for Clinical Research and Prevention

Frederiksberg, Copenhagen, 2000, Denmark

Location

University of Copenhagen

Copenhagen, 2200, Denmark

Location

Steno Diabetes Center Copenhagen

Copenhagen, 2730, Denmark

Location

Related Publications (1)

• 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.

  PMID: 37726771 DERIVED

MeSH Terms

Conditions

Sedentary Behavior; Burnout, Psychological; Motor Activity

Condition Hierarchy (Ancestors)

Behavior; Stress, Psychological; Behavioral Symptoms

Study Officials

• Glen Nielsen, PhD

  University of Copenhagen

  PRINCIPAL INVESTIGATOR

• Mads Bølling, PhD

  Steno Diabetes Center Copenhagen

  STUDY DIRECTOR

• Peter Elsborg, PhD

  Center for Clinical Research and Prevention

  STUDY DIRECTOR

• Charlotte D Klinker, PhD

  Steno Diabetes Center Copenhagen

  STUDY CHAIR

• Peter Bentsen, PhD

  Center for Clinical Research and Prevention

  STUDY CHAIR

• Lærke M Grønfeldt, Msc

  Center for Clinical Research and Prevention

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: January 19, 2022
• First Posted: February 14, 2022
• Study Start: February 23, 2022
• Primary Completion: June 21, 2023
• Study Completion: June 27, 2023
• Last Updated: May 16, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, ANALYTIC CODE
• 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.
• Access Criteria: Data can be made available upon reasonable request to the PI such as e.g. verification of the research results.

Locations

DK (3)