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RecruitingNCT058220243PLUpdated Mar 20, 2026

Promoting Pupils' Physical Literacy

An interventional study of Promoting Pupils' Physical Literacy Intervention in Literacy, sponsored by Center for Clinical Research and Prevention. Recruiting at 3 sites in Denmark. Open to participants aged 8 Years to 13 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-03-20.

Sponsored by Center for Clinical Research and Prevention · Not applicable, Interventional, and Prevention

From the registry’s dates

  • Primary completion was expected by Jun 2026, 4 months ago, but the record still lists the study as recruiting.
  • Started Feb 2023; still recruiting 3 years 9 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
336
Allocation
Randomized
Ages
8 Years to 13 Years
Sex
All
01

Study summary

This pilot study aims to test the feasibility and acceptability of a previously developed and tested physical literacy (PL) intervention. 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 a 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.

Read the 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.

02

Conditions studied

  • Literacy

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Keywords

  • Physical literacy
  • Physical education
  • School children
  • School based intervention
  • Education
  • Health promotion
  • Prevention
03

In context

Literacy

201 studies on the registry are indexed under Literacy; 69 are open to participants now.

This study's planned enrollment of 336 is above the median of 124 across 170 interventional studies indexed under Literacy.

Browse Literacy studies →

Lead sponsor

Center for Clinical Research and Prevention is the lead sponsor of 10 studies on the registry; 5 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
8 Years to 13 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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 , allowing their child to participate
  • Pupils who have provide an oral assessment

Exclusion criteria

Exclusion Criteria:

  • Pupils who do not live up to the inclusion criteria
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
336 participants (estimated)

Study arms

  • 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.

    Behavioral: Promoting Pupils' Physical Literacy Intervention

  • 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.

Interventions

  • BehavioralPromoting Pupils' Physical Literacy Intervention

    The physical literacy intervention 3PL is based on activities, games, and modifications of the physical education classes to target and enhance pupils' physical literacy.

    Also known as: 3PL

06

What researchers measure

Primary outcomes

  1. Acceptance rate

    Percentage of invited schools participating.

    Time frame: 6 months

  2. Success of intervention implementation in PE lessons

    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.

    Time frame: 11 months

  3. Success of intervention implementation in school systems

    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.

    Time frame: 11 months

  4. Success of intervention implementation for pupils

    Qualitative interviews with pupils will be undertaken to understand their experiences of the PE lessons.

    Time frame: 11 months

Secondary outcomes

  1. Physical literacy (preliminary effectiveness)

    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.

    Time frame: 11 months

  2. Daily physical activity (preliminary effectiveness)

    Physical Activity will be measured with Axivity® AX3 accelerometers worn for 7 consecutive days. Axivity tracks physical activity in activity counts.

    Time frame: 11 months

07

Study locations

3 of 3 sites recruiting
08

References and documents

Publications

  • Amholt TT, Kurtzhals M, Melby P, Bolling M, Moller OM, Lise MK, Stage A, O'Brien W, Belton S, Elsborg P, Nielsen G, Bentsen P. Feasibility of the Promoting Pupils' Physical Literacy (3PL) intervention: Does it work? Will it work? Pilot Feasibility Stud. 2026 Mar 28;12(1):60. doi: 10.1186/s40814-026-01806-w. PubMed 41904598 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 20, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05822024
Lead sponsor
Center for Clinical Research and Prevention
Collaborators
University of Copenhagen, TrygFonden, Denmark
Responsible party
Peter Bentsen (Center Director and Affiliated Professor, Center for Clinical Research and Prevention) — Principal investigator
First posted
Apr 20, 2023
Start date
Feb 1, 2023
Primary completion
Jun 30, 2026 (estimated)
Completion
Sep 30, 2026 (estimated)
Last update
Mar 20, 2026

Study contacts

Peter Bentsen, PhD
Contact
peter.bentsen@regionh.dk
+4540824586
Thea Toft Amholt, PhD
Contact
thea.toft.amholt@regionh.dk
+4542427323
Peter Bentsen, PhD
principal investigator · Center for Clinical Research and Prevention
Peter Elsborg, PhD
study director · Center for Clinical Research and Prevention
Mads Bølling, PhD
study director · Center for Clinical Research and Prevention
Thea Toft Amholt, PhD
study director · Center for Clinical Research and Prevention
Glen Nielsen, PhD
study director · University of Copenhagen
Paulina Melby, PhD
study director · University of Copenhagen
Mette Kurtzhals, Cand.scient
study director · University of Southern Denmark

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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