PA4WELL primary schools program: a study to increase students’ cardiorespiratory fitness and contribute their physical, social and mental health

ISRCTN ISRCTN10820452
DOI https://doi.org/10.1186/ISRCTN10820452
Sponsor University of Jyväskylä
Funder Jane ja Aatos Erkon Säätiö
Submission date
25/06/2026
Registration date
25/06/2026
Last edited
25/06/2026
Recruitment status
Not yet recruiting
Overall study status
Ongoing
Condition category
Other
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Mr Timo Jaakkola
Public, Scientific, Principal investigator

Faculty of Sport and Health Sciences
University of Jyväskylä
P.O. Box 35 (L)
Jyväskylä
FI-40014
Finland

ORCiD logo 0000-0003-1227-2460
+358408053949
timo.jaakkola@jyu.fi

Study information

Primary study designInterventional
AllocationRandomized controlled trial
MaskingBlinded (masking used)
ControlActive
AssignmentParallel
PurposePrevention
Scientific titlePA4WELL primary schools program: a hybrid effectiveness -implementation trial to increase students’ cardiorespiratory fitness and contribute their physical, social and mental health
Study acronymPA4WELL
Study objectives 1. To evaluate the effectiveness of the PA4WELL whole-of-school physical activity intervention on cardiorespiratory fitness (primary outcome) among Grade 5 students compared to a control group.
2. To assess the effects of the intervention on secondary health outcomes, including physical activity levels, recovery during the school day and sleep (heart rate variability), and mental and social health.
3. To compare the effectiveness of two levels of implementation support (high vs. low) in improving student outcomes.
4. To examine implementation outcomes of the PA4WELL intervention across study arms, including the proportion of schools implementing at least four of the six intervention components.
5. To identify determinants of implementation (teachers’ capability, opportunity, and motivation) and evaluate key implementation outcomes, including acceptability, adoption, appropriateness, feasibility, fidelity, cost, penetration, and sustainability.
Ethics approval(s)

Approved 24/04/2026, Human Sciences Ethics Committee of the University of Jyväskylä (University of Jyväskylä, PO Box 35, Jyväskylä, FI-40014, Finland; +358 (0)14 260 1211; tutkimusetiikka@jyu.fi), ref: 542/13.00.04.00/2026

Health condition(s) or problem(s) studiedCardiorespiratory fitness, physical activity and physical, mental, and social health and well-being among primary school children.
InterventionThis study is a three-arm cluster randomized controlled trial conducted in 30 Finnish primary schools including approximately 1200 Grade 5 students (aged ~11 years), their teachers, school principals, and parents/guardians.
After recruitment, schools will be matched into sets based on baseline characteristics (previous fitness test results, school size, municipality type, and prior participation in the Finnish Schools on the Move programme). Randomisation will be conducted within matched sets (1:1:1 ratio) by an independent statistician using a computer-generated random number sequence, ensuring allocation concealment.

Schools will be allocated to one of three arms:
1. High implementation support
2. Low implementation support
3. Control (usual practice)

Intervention (arms 1 and 2):

All intervention schools will implement the PA4WELL whole-of-school physical activity intervention based on the WHO framework. The intervention includes six components:
(1) quality physical education,
(2) active travel to and from school,
(3) physical activity opportunities before and after school,
(4) physical activity during recess and lunch,
(5) physically active classrooms, and
(6) targeted physical activity support for students with additional needs.

The intervention engages multiple stakeholders within the school community. Teachers and principals are involved in planning and implementation processes, while parents/guardians are engaged through communication materials (e.g. parent meetings and newsletters) supporting children’s physical activity behaviours at home.

Implementation support:

1. High support arm: face-to-face and online support, including workshops for teachers, leadership support for principals, school visits, ongoing facilitation, and structured feedback.
2. Low support arm: online support only (digital materials, videos, and guidance via platform).
3. Control arm: no intervention or implementation support during the study period.

Duration and follow-up:
The intervention lasts 6 months and is implemented in two waves (2026-2027 & 2027-2028). Outcomes are assessed at baseline, post-intervention (7 months), and follow-up (19 months).

Where feasible, outcome assessors will be blinded to group allocation.
Intervention typeBehavioural
Primary outcome measure(s)
  1. Cardiorespiratory fitness (students) measured using 20-metre shuttle run test (number of laps completed) at baseline, 7 months (post-intervention), and 19 months (follow-up)
Key secondary outcome measure(s)
  1. Physical activity (students) measured using Actigraph wGT3X-BT accelometer (7 days) at baseline, 7 months (post-intervention), and 19 months (follow-up)
  2. Recovery during the day and sleep (students) measured using Firstbeat Bodyguard 3 heart rate variability measurement (5 days) at baseline, 7 months (post-intervention), and 19 months (follow-up)
  3. Well-being (students) measured using WHO-5 Well-Being Index at baseline, 7 months (post-intervention), and 19 months (follow-up)
  4. Mental and social health (students) measured using Strengths and Difficulties Questionnaire (SDQ) at baseline, 7 months (post-intervention), and 19 months (follow-up)
  5. School engagements (students) measured using Study Engagement Scale at baseline, 7 months (post-intervention), and 19 months (follow-up)
  6. Study burnout (students) measured using Study Burnout Inventory at baseline, 7 months (post-intervention), and 19 months (follow-up)
  7. Self-reported physical activity (students) measured using Two-item physical activity questionnaire at baseline, 7 months (post-intervention), and 19 months (follow-up)
  8. Perceived physical competence (students) measured using Sport competence subscale of the Physical Self-Perception Profile at baseline, 7 months (post-intervention), and 19 months (follow-up)
  9. Body mass index (students) measured using weight and height at baseline, 7 months (post-intervention), and 19 months (follow-up)
  10. Parental support for children’s physical activity (guardians) measured using Family Physical Activity Environment questionnaire at baseline, 7 months (post-intervention), and 19 months (follow-up)
  11. Implementation of whole-of-school physical activity components measured using number of components implemented in previous month at 7 months (post-intervention), and 19 months (follow-up)
  12. Teachers’ capability, opportunity, and motivation to implement the intervention measured using COM-PASS scale at baseline, 7 months (post-intervention), and 19 months (follow-up)
Completion date31/05/2029

Eligibility

Participant type(s)
Age groupChild
Lower age limit10 Years
Upper age limit14 Years
SexAll
Target sample size at registration1200
Total final enrolment960
Key inclusion criteria1. Grade 5 students (typically aged 11-12 years) enrolled in participating primary schools in Central Finland
2. Primary schools in Central Finland with Grade 5 classes
3. Principals of participating primary schools in Central Finland
4. Grade 5 teachers and, where applicable, physical education (PE) teachers responsible for teaching PE to Grade 5 students in participating schools
5. Legal guardians of participating students
Key exclusion criteria1. Schools with combined classes (e.g. 5-6)
2. Special schools and teacher training schools
3. Schools with a specific focus on sports
4. Individuals unable to participate in study procedures or provide informed consent (for example, due to insufficient language proficiency)
Date of first enrolment02/08/2026
Date of final enrolment30/10/2027

Locations

Countries of recruitment

  • Finland

Study participating centre

Schools in Central Finland
-
Jyväskylä
40600
Finland

Results and Publications

Individual participant data (IPD) Intention to shareNo

Editorial Notes

25/06/2026: Study’s existence confirmed by the Human Sciences Ethics Committee of the University of Jyväskylä, Finland.

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