Literacy3PLNCT05822024
Promoting Pupils' Physical Literacy
A study testing Promoting Pupils' Physical Literacy Intervention in people with Literacy, run by Center for Clinical Research and Prevention at 3 sites in Denmark.
Trial 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… Read more about this study
- Who is it for?
- Ages 8 to 13 yearsHealthy volunteers can take part
- Conditions the study is for
- Literacy
- What is being tested?
- Promoting Pupils' Physical Literacy Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 336 participants
- Where
- 3 sitesDenmark
- Study dates
- 1 Feb 2023to 30 Sep 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 to 13 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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
Who cannot join
- Pupils who do not live up to the inclusion criteria
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Denmark3 sites, 3 recruiting
- Recruiting
Center for Clinical Research and Prevension, Frederiksberg and Bispebjerg Hospital
Copenhagen, Frederiksberg, 2000
Peter Bentsen, PhD, +4540824586, peter.bentsen@regionh.dk
- Recruiting
University of Copenhagen
Copenhagen, Nørrebro, Nørre Allé 51
Glen Nielsen, PhD, gnielsen@nexs.ku.dk
- Recruiting
University of Southern Denmark
Odense, Odense M, 5230
Paulina Melby, PhD, paulina.sander.melby@regionh.dk
About this study
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.
- Conditions
- Literacy
- Being tested
- Promoting Pupils' Physical Literacy Intervention
- Keywords
- Physical literacy, Physical education, School children, School based intervention, Education, Health promotion, Prevention
- Medical subject headings
- Literacy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Promoting Pupils' Physical Literacy InterventionBehavioural
Also called 3PL
The physical literacy intervention 3PL is based on activities, games, and modifications of the physical education classes to target and enhance pupils' physical literacy.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | Two schools (grade 4-5) will be randomly assigned to recieve the 3PL intervention in their physical education classes during one school year. Receives: Behavioral: Promoting Pupils' Physical Literacy Intervention |
| Control group | No intervention | Two schools (grade 4-5) will be randomly assigned to the control group and will continue their normal physical education classes. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Acceptance rate
Percentage of invited schools participating.
Measured: 6 months
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.
Measured: 11 months
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.
Measured: 11 months
Success of intervention implementation for pupils
Qualitative interviews with pupils will be undertaken to understand their experiences of the PE lessons.
Measured: 11 months
Secondary outcomes (2)
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.
Measured: 11 months
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.
Measured: 11 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2023
- Study start1 Feb 2023
- Primary completion30 Jun 2026 (estimated)
- Study completion30 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for LiteracyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 336 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Center for Clinical Research and Prevention
- Sponsor type
- Research network
- Collaborators
- University of Copenhagen, TrygFonden, Denmark
- Responsible party
- Principal investigator, Peter Bentsen, Center for Clinical Research and Prevention
- Investigators
- Peter Bentsen, PhD, Principal investigator, Center for Clinical Research and PreventionPeter Elsborg, PhD, Study director, Center for Clinical Research and PreventionMads Bølling, PhD, Study director, Center for Clinical Research and PreventionThea Toft Amholt, PhD, Study director, Center for Clinical Research and PreventionGlen Nielsen, PhD, Study director, University of CopenhagenPaulina Melby, PhD, Study director, University of CopenhagenMette Kurtzhals, Cand.scient, Study director, University of Southern Denmark
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05822024
- Sponsor's protocol ID
- TRYG153181
- Acronym
- 3PL
- Status last verified
- Mar 2026
- First submitted
- 3 Apr 2023
- Last updated
- 20 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Promoting Pupils' Physical Literacy
- ClinicalTrials.gov ID
- NCT05822024
- Acronym / sponsor ID
- 3PL / TRYG153181
- Conditions
- Literacy
- Keywords
- Physical literacy, Physical education, School children, School based intervention, Education, Health promotion, Prevention
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 336 participants (estimated)
- Lead sponsor
- Center for Clinical Research and PreventionResearch network
- Collaborators
- University of Copenhagen, TrygFonden, Denmark
- Study start
- 1 Feb 2023 (actual)
- Primary completion
- 30 Jun 2026 (estimated)
- Study completion
- 30 Sep 2026 (estimated)
- First posted
- 20 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Behavioral: Promoting Pupils' Physical Literacy InterventionTwo schools (grade 4-5) will be randomly assigned to recieve the 3PL intervention in their physical education classes during one school year. |
| Control group | No intervention | –Two schools (grade 4-5) will be randomly assigned to the control group and will continue their normal physical education classes. |
Who may qualify
- Ages
- 8 to 13 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (1 listed)
- Pupils who do not live up to the inclusion criteria
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Promoting Pupils' Physical Literacy InterventionAlso: 3PLThe physical literacy intervention 3PL is based on activities, games, and modifications of the physical education classes to target and enhance pupils' physical literacy. | Behavioural | Intervention group |
Primary outcome
Acceptance rate
Time frame: 6 months
Percentage of invited schools participating.
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.
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.
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.
2 secondary outcomes
Physical literacy (preliminary effectiveness)
Time frame: 11 months
Daily physical activity (preliminary effectiveness)
Time frame: 11 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 2026.
- Derived from this study: PubMed 41904598Amholt 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.
- Adaptation ProtocolLink provided by the sponsor.
- Individual participant dataSharing planned: No
Related trials for Literacy
Not yet recruiting
Artificial Intelligence and Digital Health Literacies Among Older Adults: A Mixed-method Pilot Intervention Study
Digital Health Literacy, AI Chatbot
Not yet recruiting
Podcast-supported Education on Climate Change Awareness, Anxiety, and Health Literacy Levels in Nursing Students
Podcast, Nursing Students
Recruiting
AI-Simplified Discharge Summaries to Improve Patient Comprehension (ContextCare)
Patient Discharge, Health Literacy
Not yet recruiting
The Effects of a Scenario-based Fact-checking Course on eHealth Literacy and Fact-checking Skills Among Older Adults.
eHealth Literacy, Digital Health Literacy
Not yet recruiting
Self-Concept Reinforcement for Early School Readiness
Child Behavior, Child Behavior Problem
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
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
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Promoting Pupils' Physical Literacy Intervention in people with Literacy, run by Center for Clinical Research and Prevention at 3 sites in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 20 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Peter Bentsen, PhD (+4540824586, peter.bentsen@regionh.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Acceptance rate (time frame: 6 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05822024, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Mar 2026; AzTrials last refreshed its copy on 27 Oct 2026.