- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05822024
Promoting Pupils' Physical Literacy (3PL)
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
This pilot study aims to test the feasibility and acceptability of a previously developed and tested physical literacy (PL) intervention. Regular participation in physical activity (PA) through life can improve health and reduce the risk of developing several chronic diseases like diabetes, cancer, and cardiovascular disease. However, a considerable number of Danish children and adolescents do not meet national PA recommendations. Over the last few years, the construct of PL has gained popularity around the world and has become recognized as a proximal measure for lifelong engagement in PA. PL is a multidisciplinary and comprehensive concept describing an individual's prerequisites to participate in and adhere to physical activities throughout the life course PL includes the elements motivation, confidence, motor skills, physical capacity, knowledge and understanding. In Denmark, development towards theoretically driven and evidence-based PL interventions that aim to increase children's PL have not yet begun. A promising and internationally tested intervention, the Youth Physical Activity Towards Health (Y-PATH), is based on the theory of PL and has proven to be effectful on children's PA levels and motor skills. The Promoting Pupils' Physical Literacy (3 PL) project aims to test the feasibility and acceptability of the previously developed and tested Y-PATH intervention in a Danish context among pupils (9-11 years of age). The hypothesis is that a revised 3 PL intervention protocol, aiming to increase pupils' PL, is ready for effectiveness testing by the end of this project.
Four schools will be recruited and randomly assigned to intervention or control condition. The primary outcomes include the feasibility and acceptability of the 3 PL intervention and will be in concordance with guidance proposed by the Medical Research Council and The Common Guidelines for Education Research and Development. Feasibility of the practicality and recruitment process will be assessed within a document log administered by the project group. The acceptability including demand and experiences, and the intervention implementation degree (secondary outcome) will be evaluated by short bimonthly questionnaires to teachers and interviews with pupils, teachers, parents, and school managers. Preliminary effectiveness (secondary outcome) will be tested by comparing changes in pupils' PL assessed with the Danish Assessment of Physical Literacy (DAPL) tool.
First and foremost, the testing of feasibility and acceptability of a previously developed international intervention will provide a revised 3 PL intervention, a Template for Intervention Description and Replication TIDieR checklist and a protocol, which will provide a solid empirical and theoretical foundation for a future upscaled effectiveness study. The development of a TIDieR checklist and a protocol provides international and national researchers the opportunity to use and compare effectiveness across countries and cultures.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Peter Bentsen, PhD
- Phone Number: +4540824586
- Email: peter.bentsen@regionh.dk
Study Contact Backup
- Name: Thea Toft Amholt, PhD
- Phone Number: +4542427323
- Email: thea.toft.amholt@regionh.dk
Study Locations
-
-
Frederiksberg
-
Copenhagen, Frederiksberg, Denmark, 2000
- Recruiting
- Center for Clinical Research and Prevension, Frederiksberg and Bispebjerg Hospital
-
Contact:
- Peter Bentsen, PhD
- Phone Number: +4540824586
- Email: peter.bentsen@regionh.dk
-
-
Nørrebro
-
Copenhagen, Nørrebro, Denmark, Nørre Allé 51
- Recruiting
- University of Copenhagen
-
Contact:
- Glen Nielsen, PhD
- Email: gnielsen@nexs.ku.dk
-
-
Odense M
-
Odense, Odense M, Denmark, 5230
- Recruiting
- University of Southern Denmark
-
Contact:
- Paulina Melby, PhD
- Email: paulina.sander.melby@regionh.dk
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
Description
Inclusion Criteria:
School/class-level
- Non-special needs municipal school classes
- Classes that are not in other school development or research projects which would most likely influence and bias the results
Pupil-level
- Pupils with parents/guardians who have provided written informed consent, allowing their child to participate
- Pupils who have provide an oral assessment
Exclusion Criteria:
- Pupils who do not live up to the inclusion criteria
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Intervention group
Two schools (grade 4-5) will be randomly assigned to recieve the 3PL intervention in their physical education classes during one school year.
|
The physical literacy intervention 3PL is based on activities, games, and modifications of the physical education classes to target and enhance pupils' physical literacy.
Other Names:
|
|
No Intervention: Control group
Two schools (grade 4-5) will be randomly assigned to the control group and will continue their normal physical education classes.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Acceptance rate
Time Frame: 6 months
|
Percentage of invited schools participating.
|
6 months
|
|
Success of intervention implementation in PE lessons
Time Frame: 11 months
|
Three observations during physical education lessons (PE) that assess the acceptability of the intervention.
Also, PE teachers will receive a weekly questionnaire to assess whether they have used the intervention materials in their PE lessons.
|
11 months
|
|
Success of intervention implementation in school systems
Time Frame: 11 months
|
Qualitative interviews with school managers and teachers will be undertaken to detect perceived positive or negative effects on organization and how the intervention fits within the school culture.
|
11 months
|
|
Success of intervention implementation for pupils
Time Frame: 11 months
|
Qualitative interviews with pupils will be undertaken to understand their experiences of the PE lessons.
|
11 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Physical literacy (preliminary effectiveness)
Time Frame: 11 months
|
This study will assess PL among the pupils before and after the intervention period using the Danish Assessment of Physical Literacy (DAPL) that has been developed and validated in the DAPL project supported by TrygFonden #125640.
|
11 months
|
|
Daily physical activity (preliminary effectiveness)
Time Frame: 11 months
|
Physical Activity will be measured with Axivity® AX3 accelerometers worn for 7 consecutive days.
Axivity tracks physical activity in activity counts.
|
11 months
|
Collaborators and Investigators
Investigators
- Principal Investigator: Peter Bentsen, PhD, Center for Clinical Research and Prevention
- Study Director: Mads Bølling, PhD, Center for Clinical Research and Prevention
- Study Director: Thea Toft Amholt, PhD, Center for Clinical Research and Prevention
- Study Director: Glen Nielsen, PhD, University of Copenhagen
- Study Director: Paulina Melby, PhD, University of Copenhagen
- Study Director: Mette Kurtzhals, Cand.scient, University of Southern Denmark
- Study Director: Peter Elsborg, PhD, Center for Clinical Research and Prevention
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
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
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- TRYG153181
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
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.
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