Promoting Pupils' Physical Literacy

Literacy Clinical Trial

— 3PL  

Official title:

Promoting Pupils' Physical Literacy

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05822024
• Other study ID #: TRYG153181
• Status: Active, not recruiting
• Phase: N/A
• Start date: February 1, 2023
• Est. completion date: June 30, 2025

Study information

• Verified date: April 2023
• Source: Center for Clinical Research and Prevention
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 336
• Est. completion date: June 30, 2025
• Est. primary completion date: June 30, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 8 Years to 13 Years

Eligibility

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

Related Conditions & MeSH terms

• Literacy

Intervention

Behavioral:
• Promoting 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.

Locations

Country	Name	City	State
Denmark	Center for Clinical Research and Prevension, Frederiksberg and Bispebjerg Hospital	Copenhagen	Frederiksberg
Denmark	University of Copenhagen	Copenhagen	Nørrebro
Denmark	University of Southern Denmark	Odense	Odense M

Sponsors (3)

Lead Sponsor	Collaborator
Center for Clinical Research and Prevention	TrygFonden, Denmark, University of Copenhagen

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Acceptance rate	Percentage of invited schools participating.	6 months
Primary	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
Primary	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
Primary	Success of intervention implementation for pupils	Qualitative interviews with pupils will be undertaken to understand their experiences of the PE lessons.	11 months
Secondary	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.	11 months
Secondary	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.	11 months

External Links

•   Adaptation Protocol