MOVEOUT: A Cluster RCT Investigating Education Outside the Classroom
NCT ID: NCT05237674
Last Updated: 2024-05-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
730 participants
INTERVENTIONAL
2022-02-23
2023-06-27
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Effects of the Inclusion of Physical Activity in Secondary School Academic Classes: the ACTIVE CLASS Study
NCT05891054
Evaluation of the Move 2 Learn (M2L) Program for Young Children
NCT03999619
Training and Detraining Effects of a Physical Activity Program Implemented Through Mobile Applications in Adolescents.
NCT06164041
Effectiveness of a Multicomponent Intervention to Promote Physical Activity Levels During the School Day (MOVESCHOOL)
NCT06254638
Program to Promote Physical Activity and Healthy Habits in Adolescents
NCT03974607
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Intervention schools
School children exposed to 1-2 weekly sessions, a total of at least five hours pr week, of education outside the classroom.
The TEACHOUT intervention
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.
Waiting control schools
The waiting control schools will receive the two-day training course on EOtC one year later immediately after post measurements are conducted.
No interventions assigned to this group
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
The TEACHOUT intervention
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.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* 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.
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Steno Diabetes Center Copenhagen
OTHER
Center for Clinical Research and Prevention
NETWORK
University of Copenhagen
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Glen Nielsen, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Copenhagen
Mads Bølling, PhD
Role: STUDY_DIRECTOR
Steno Diabetes Center Copenhagen
Peter Elsborg, PhD
Role: STUDY_DIRECTOR
Center for Clinical Research and Prevention
Charlotte D Klinker, PhD
Role: STUDY_CHAIR
Steno Diabetes Center Copenhagen
Peter Bentsen, PhD
Role: STUDY_CHAIR
Center for Clinical Research and Prevention
Lærke M Grønfeldt, Msc
Role: STUDY_DIRECTOR
Center for Clinical Research and Prevention
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Center for Clinical Research and Prevention
Frederiksberg, Copenhagen, Denmark
University of Copenhagen
Copenhagen, , Denmark
Steno Diabetes Center Copenhagen
Copenhagen, , Denmark
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
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.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2124712
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.