Clinical trial NCT05822024: Promoting Pupils' Physical Literacy
Official title: Promoting Pupils' Physical Literacy
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Literacy
Keywords: Physical literacy
Physical education
School children
School based intervention
Education
Health promotion
Prevention
Lead sponsor: Center for Clinical Research and Prevention
Sponsor class: NETWORK
Collaborators: name: University of Copenhagen
name: TrygFonden, Denmark
First posted: 2023-04-20
Enrollment: 336
Sex: ALL
Minimum age (years): 8
Maximum age (years): 13
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Acceptance rate
timeFrame: 6 months
measure: Success of intervention implementation in PE lessons
timeFrame: 11 months
measure: Success of intervention implementation in school systems
timeFrame: 11 months
measure: Success of intervention implementation for pupils
timeFrame: 11 months
Secondary outcomes:
measure: Physical literacy (preliminary effectiveness)
timeFrame: 11 months
measure: Daily physical activity (preliminary effectiveness)
timeFrame: 11 months
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Center for Clinical Research and Prevension, Frederiksberg and Bispebjerg Hospital
state: Frederiksberg
city: Copenhagen
country: Denmark
facility: University of Copenhagen
state: Nørrebro
city: Odense
country: Denmark
facility: University of Southern Denmark
state: Odense M
Study officials:
affiliation: Center for Clinical Research and Prevention
name: Peter Bentsen, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Center for Clinical Research and Prevention
name: Peter Elsborg, PhD
role: STUDY_DIRECTOR
affiliation: Center for Clinical Research and Prevention
name: Mads Bølling, PhD
role: STUDY_DIRECTOR
affiliation: Center for Clinical Research and Prevention
name: Thea Toft Amholt, PhD
role: STUDY_DIRECTOR
affiliation: University of Copenhagen
name: Glen Nielsen, PhD
role: STUDY_DIRECTOR
affiliation: University of Copenhagen
name: Paulina Melby, PhD
role: STUDY_DIRECTOR
affiliation: University of Southern Denmark
name: Mette Kurtzhals, Cand.scient
role: STUDY_DIRECTOR
References: