NCT05822024

Brief 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
336

participants targeted

Target at P75+ for not_applicable

Timeline
5mo left

Started Feb 2023

Longer than P75 for not_applicable

Geographic Reach
1 country

3 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress89%
Feb 2023Sep 2026

Study Start

First participant enrolled

February 1, 2023

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

April 3, 2023

Completed
17 days until next milestone

First Posted

Study publicly available on registry

April 20, 2023

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2026

Expected
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2026

Last Updated

March 20, 2026

Status Verified

March 1, 2026

Enrollment Period

3.4 years

First QC Date

April 3, 2023

Last Update Submit

March 18, 2026

Conditions

Keywords

Physical literacyPhysical educationSchool childrenSchool based interventionEducationHealth promotionPrevention

Outcome Measures

Primary Outcomes (4)

  • Acceptance rate

    Percentage of invited schools participating.

    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.

    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.

    11 months

  • Success of intervention implementation for pupils

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

    11 months

Secondary Outcomes (2)

  • Physical literacy (preliminary effectiveness)

    11 months

  • Daily physical activity (preliminary effectiveness)

    11 months

Study Arms (2)

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.

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.

Interventions

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
Intervention group

Eligibility Criteria

Age8 Years - 13 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Center for Clinical Research and Prevension, Frederiksberg and Bispebjerg Hospital

Copenhagen, Frederiksberg, 2000, Denmark

RECRUITING

University of Copenhagen

Copenhagen, Nørrebro, Nørre Allé 51, Denmark

RECRUITING

University of Southern Denmark

Odense, Odense M, 5230, Denmark

RECRUITING

Related Publications (1)

  • 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. doi: 10.1186/s40814-026-01806-w. Online ahead of print.

Related Links

MeSH Terms

Conditions

Literacy

Condition Hierarchy (Ancestors)

CommunicationBehavior

Study Officials

  • Peter Bentsen, PhD

    Center for Clinical Research and Prevention

    PRINCIPAL INVESTIGATOR
  • Peter Elsborg, 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

Central Study Contacts

Peter Bentsen, PhD

CONTACT

Thea Toft Amholt, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
NETWORK
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Center Director and Affiliated Professor

Study Record Dates

First Submitted

April 3, 2023

First Posted

April 20, 2023

Study Start

February 1, 2023

Primary Completion (Estimated)

June 30, 2026

Study Completion (Estimated)

September 30, 2026

Last Updated

March 20, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

Locations