ChildrenPLAYNCT07421128
The Pause, Learn, and Activate Yourself (PLAY)
A study testing Teacher-led Active Breaks and Video-guided Active Breaks in people with Children, run by University of Pavia.
Trial summary
Many children spend a large part of the school day sitting, which can limit their opportunities to be physically active. Regular physical activity is important for children's physical health, mental well-being, and positive attitudes toward movement. Read more about this study
- Who is it for?
- Ages 5 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Children
- What is being tested?
- Teacher-led Active Breaks and Video-guided Active Breaks
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 810 participants
- Where
- No sites listed yet
- Study dates
- 16 Feb 2026to 15 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 5 to 12 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Regular participation in school activities and physical education classes.
- Ability to understand and follow the instructions related to the study protocol.
- Enrollment in the study through verbal assent from the child and written informed consent from a parent or legal guardian.
Who cannot join
- Any medical contraindication to participation in physical activity.
- Musculoskeletal injuries occurring within the three months prior to baseline assessment.
- Physical or cognitive limitations that prevent participation in the planned activities.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Active Breaks in School: The Pause, Learn, and Activate Yourself (PLAY) Cluster-Randomized Controlled Trial
Many children spend a large part of the school day sitting, which can limit their opportunities to be physically active. Regular physical activity is important for children's physical health, mental well-being, and positive attitudes toward movement. Schools represent an ideal setting to promote healthy behaviors, as they reach nearly all children on a daily basis.
This study aims to evaluate the effects of short, classroom-based Active Breaks on children attending primary school. Active Breaks are brief periods of physical activity integrated into regular classroom lessons. These activities are designed to be fun, safe, and easy to perform in the classroom, without reducing academic teaching time.
Read more
The main goal of the study is to assess whether participating in Active Breaks improves children's enjoyment of physical activity. Enjoyment is an important factor because children who find physical activity enjoyable are more likely to stay active over time. The study also examines whether Active Breaks influence physical activity levels, basic motor skills, physical fitness perception, attention and executive functions, vitality, and quality of life.
The intervention lasts 12 weeks and is carried out during the normal school timetable. In the intervention group, children perform one Active Break during each school hour. Each break lasts approximately 5 minutes and includes playful aerobic and strength-based movements that require little or no equipment. The activities are guided by classroom teachers, who receive specific training and materials before the start of the study. A comparison group continues with the usual classroom routine without Active Breaks.
Participation in the study is voluntary. Parents or legal guardians provide written informed consent, and children provide verbal assent. All activities are appropriate for primary school children and are conducted in a safe and supervised environment. Children may withdraw from the study at any time without any consequences.
The results of this study may help schools and policymakers understand whether simple, low-cost strategies such as Active Breaks can promote healthier and more active school days for children.
- Conditions
- Children
- Being tested
- Teacher-led Active Breaks, Video-guided Active Breaks
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Teacher-led Active BreaksOther
The intervention consists of classroom-based, teacher-led Active Breaks (ABs) integrated into regular school lessons. ABs are short bouts of physical activity aimed at reducing sedentary time and promoting moderate-to-vigorous physical activity without reducing instructional time.
The intervention lasts 12 weeks and is delivered once every school hour. Each AB lasts approximately 5 minutes. All activities take place during the regular school timetable in primary school classrooms.
ABs include standardized, playful aerobic and muscle-strengthening exercises requiring little or no equipment and adaptable to classroom spaces. Activities are cognitively engaging and emphasize enjoyment, participation, and inclusiveness rather than performance. Classroom teachers deliver the ABs live after receiving standardized training and instructional materials to ensure consistent implementation with the video-guided group.
Video-guided Active BreaksOther
The intervention consists of classroom-based Active Breaks (ABs), delivered through pre-recorded instructional videos integrated into regular school lessons. ABs are short bouts of physical activity aimed at reducing sedentary time and promoting moderate-to-vigorous physical activity without reducing instructional time.
The intervention lasts 12 weeks and is delivered once every school hour. Each Active Break lasts approximately 5 minutes and is preceded by a brief introductory segment within the video. Activities are conducted during the regular school timetable in primary school classrooms.
Video-guided ABs include standardized, playful aerobic and muscle-strengthening exercises requiring little or no equipment and adaptable to classroom spaces. Activities are cognitively engaging and emphasize enjoyment, participation, and inclusiveness rather than performance. Classroom teachers facilitate transitions but do not actively lead the exercises.
| Study group | Role | What they receive |
|---|---|---|
| Usual routine | No intervention | Not described |
| Video-guided Active Breaks | Experimental | Not described Receives: Other: Video-guided Active Breaks |
| Teacher-led Active Breaks | Experimental | Not described Receives: Other: Teacher-led Active Breaks |
What is being measured
The primary outcome is the main question the study is designed to answer.
Perceived enjoyment of physical activity
Perceived enjoyment of physical activity will be assessed using the Physical Activity Enjoyment Scale (PACES) questionnaire. The outcome is the change in total PACES score (unit: questionnaire score) from baseline (Week 0) to post-intervention (Week 12).
Measured: From enrollment to the end of treatment at 12 weeks
Secondary outcomes (16)
Motor competence
Motor competence will be assessed using the Motorische Basiskompetenzen (MOBAK) test battery. The outcome is the change in total MOBAK score (unit: points) from baseline to post-intervention. The MOBAK assesses basic motor competencies across object control and self-movement domains, with a total possible score of 0-16 points, using age-appropriate versions.
Measured: From enrollment to the end of treatment at 12 weeks
Objectively measured physical activity
Physical activity will be objectively assessed using FIBION wearable sensors. The outcome is the change in time spent in moderate-to-vigorous physical activity (MVPA) (unit: minutes per day) from baseline to post-intervention, derived from accelerometry-based sensor data.
Measured: From enrollment to the final week of treatment at 11 weeks
Perceived motor competence
Perceived motor competence will be assessed using the SEMOK questionnaire. The outcome is the change in SEMOK score (unit: questionnaire score) from baseline to post-intervention.
Measured: From enrollment to the end of treatment at 12 weeks
Physical fitness
Physical fitness will be assessed using a field-based test battery including the standing broad jump, handgrip strength, medicine ball throw, and 4×10 m shuttle run. The outcome is the change in a composite physical fitness score (unit: standardized score) from baseline to post-intervention.
Measured: From enrollment to the end of treatment at 12 weeks
Objectively measured sleep quality
Sleep will be objectively assessed from accelerometer data processed using the GGIR package. Sleep quality will be operationalized as wake after sleep onset (WASO) (unit: minutes per night), and the outcome will be the change in WASO from baseline to post-intervention.
Measured: From enrollment to the end of treatment at 12 weeks
Lower-limb explosive strength
Lower-limb explosive strength will be assessed using the standing broad jump. The outcome is the change in the distance jumped (unit: centimeters, cm) from baseline to post-intervention.
Measured: From enrollment to the end of treatment at 12 weeks
Upper limb explosive strength
Upper limb explosive strength will be assessed using the medicine ball throw. The outcome is the change in the thrown distance (unit: centimeters, cm) from baseline to post-intervention.
Measured: From enrollment to the end of treatment at 12 weeks
Upper limb strength
Upper limb strength will be assessed using the handgrip strength test. The test will be performed two times per each hand and the outcome is the change of the best results of both hands (unit: kilograms, kg) from baseline to post-intervention.
Measured: From enrollment to the end of treatment at 12 weeks
Speed-agility
Speed-agility will be assessed using the 4×10 m shuttle run. The outcome is the change in the test performance (unit: seconds, s) from baseline to post-intervention.
Measured: From enrollment to the end of treatment at 12 weeks
Anthropometric characteristics
Anthropometric characteristics will be assessed following the International Society for the Advancement of Kinanthropometry (ISAK) guidelines. Outcomes include changes in body weight (kg), height (cm), sitting height (cm), waist and hip circumferences (cm), and BMI z-score from baseline to post-intervention.
Measured: From enrollment to the end of treatment at 12 weeks
Body weight
Body weight will be assessed according to the International Society for the Advancement of Kinanthropometry (ISAK) guidelines using a calibrated digital scale. The outcome is the change in body weight (unit: kilograms) from baseline to post-intervention.
Measured: From enrollment to the end of treatment at 12 weeks
Standing height
Standing height will be assessed according to the International Society for the Advancement of Kinanthropometry (ISAK) guidelines using a stadiometer. The outcome is the change in standing height (unit: centimeters) from baseline to post-intervention.
Measured: From enrollment to the end of treatment at 12 weeks
Waist girth
Waist girth will be assessed according to the International Society for the Advancement of Kinanthropometry (ISAK) guidelines using a non-elastic measuring tape at the standardized anatomical landmark. The outcome is the change in waist circumference (unit: centimeters) from baseline to post-intervention.
Measured: From enrollment to the end of treatment at 12 weeks
Hip girth
Hip girth will be assessed according to the International Society for the Advancement of Kinanthropometry (ISAK) guidelines using a non-elastic measuring tape at the standardized anatomical landmark. The outcome is the change in hip circumference (unit: centimeters) from baseline to post-intervention.
Measured: From enrollment to the end of treatment at 12 weeks
Body mass index z-score (BMI z-score)
BMI z-scores will be derived using age- and sex-specific reference values. The outcome is the change in BMI z-score (unit: z-score) from baseline to post-intervention.
Measured: From enrollment to the end of treatment at 12 weeks
Waist-to-hip ratio
Waist-to-hip ratio will be calculated as waist circumference divided by hip circumference. The outcome is the change in waist-to-hip ratio (unit: ratio) from baseline to post-intervention.
Measured: From enrollment to the end of treatment at 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2026
- Study start16 Feb 2026 (estimated)
- Primary completion30 Jun 2026 (estimated)
- Study completion15 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ChildrenStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 810 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Pavia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Matteo Vandoni, University of Pavia
- Investigators
- Matteo Vandoni, Principal investigator, University of Pavia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07421128
- Sponsor's protocol ID
- PLAY-IC-2025
- Acronym
- PLAY
- Status last verified
- Feb 2026
- First submitted
- 19 Jan 2026
- Last updated
- 19 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 19 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Active Breaks in School: The Pause, Learn, and Activate Yourself (PLAY) Cluster-Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07421128
- Acronym / sponsor ID
- PLAY / PLAY-IC-2025
- Conditions
- Children
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 810 participants (estimated)
- Lead sponsor
- University of PaviaUniversity, hospital or other
- Study start
- 16 Feb 2026 (estimated)
- Primary completion
- 30 Jun 2026 (estimated)
- Study completion
- 15 Sep 2026 (estimated)
- First posted
- 19 Feb 2026 (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.
Many children spend a large part of the school day sitting, which can limit their opportunities to be physically active. Regular physical activity is important for children's physical health, mental well-being, and positive attitudes toward movement. Schools represent an ideal setting to promote healthy behaviors, as they reach nearly all children on a daily basis.
This study aims to evaluate the effects of short, classroom-based Active Breaks on children attending primary school. Active Breaks are brief periods of physical activity integrated into regular classroom lessons. These activities are designed to be fun, safe, and easy to perform in the classroom, without reducing academic teaching time.
The main goal of the study is to assess whether participating in Active Breaks improves children's enjoyment of physical activity. Enjoyment is an important factor because children who find physical activity enjoyable are more likely to stay active over time. The study also examines whether Active Breaks influence physical activity levels, basic motor skills, physical fitness perception, attention and executive functions, vitality, and quality of life.
The intervention lasts 12 weeks and is carried out during the normal school timetable. In the intervention group, children perform one Active Break during each school hour. Each break lasts approximately 5 minutes and includes playful aerobic and strength-based movements that require little or no equipment. The activities are guided by classroom teachers, who receive specific training and materials before the start of the study. A comparison group continues with the usual classroom routine without Active Breaks.
Participation in the study is voluntary. Parents or legal guardians provide written informed consent, and children provide verbal assent. All activities are appropriate for primary school children and are conducted in a safe and supervised environment. Children may withdraw from the study at any time without any consequences.
The results of this study may help schools and policymakers understand whether simple, low-cost strategies such as Active Breaks can promote healthier and more active school days for children.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Usual routine | No intervention | – |
| Video-guided Active Breaks | Experimental | Other: Video-guided Active Breaks |
| Teacher-led Active Breaks | Experimental | Other: Teacher-led Active Breaks |
Who may qualify
- Ages
- 5 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Regular participation in school activities and physical education classes.
- Ability to understand and follow the instructions related to the study protocol.
- Enrollment in the study through verbal assent from the child and written informed consent from a parent or legal guardian.
Key exclusion criteria (3 listed)
- Any medical contraindication to participation in physical activity.
- Musculoskeletal injuries occurring within the three months prior to baseline assessment.
- Physical or cognitive limitations that prevent participation in the planned activities.
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 |
|---|---|---|
| Teacher-led Active BreaksThe intervention consists of classroom-based, teacher-led Active Breaks (ABs) integrated into regular school lessons. ABs are short bouts of physical activity aimed at reducing sedentary time and promoting moderate-to-vigorous physical activity without reducing instructional time. The intervention lasts 12 weeks and is delivered once every school hour. Each AB lasts approximately 5 minutes. All activities take place during the regular school timetable in primary school classrooms. ABs include standardized, playful aerobic and muscle-strengthening exercises requiring little or no equipment and adaptable to classroom spaces. Activities are cognitively engaging and emphasize enjoyment, participation, and inclusiveness rather than performance. Classroom teachers deliver the ABs live after receiving standardized training and instructional materials to ensure consistent implementation with the video-guided group. | Other | Teacher-led Active Breaks |
| Video-guided Active BreaksThe intervention consists of classroom-based Active Breaks (ABs), delivered through pre-recorded instructional videos integrated into regular school lessons. ABs are short bouts of physical activity aimed at reducing sedentary time and promoting moderate-to-vigorous physical activity without reducing instructional time. The intervention lasts 12 weeks and is delivered once every school hour. Each Active Break lasts approximately 5 minutes and is preceded by a brief introductory segment within the video. Activities are conducted during the regular school timetable in primary school classrooms. Video-guided ABs include standardized, playful aerobic and muscle-strengthening exercises requiring little or no equipment and adaptable to classroom spaces. Activities are cognitively engaging and emphasize enjoyment, participation, and inclusiveness rather than performance. Classroom teachers facilitate transitions but do not actively lead the exercises. | Other | Video-guided Active Breaks |
Primary outcome
Perceived enjoyment of physical activity
Time frame: From enrollment to the end of treatment at 12 weeks
Perceived enjoyment of physical activity will be assessed using the Physical Activity Enjoyment Scale (PACES) questionnaire. The outcome is the change in total PACES score (unit: questionnaire score) from baseline (Week 0) to post-intervention (Week 12).
16 secondary outcomes
Motor competence
Time frame: From enrollment to the end of treatment at 12 weeks
Objectively measured physical activity
Time frame: From enrollment to the final week of treatment at 11 weeks
Perceived motor competence
Time frame: From enrollment to the end of treatment at 12 weeks
Physical fitness
Time frame: From enrollment to the end of treatment at 12 weeks
Objectively measured sleep quality
Time frame: From enrollment to the end of treatment at 12 weeks
Lower-limb explosive strength
Time frame: From enrollment to the end of treatment at 12 weeks
Upper limb explosive strength
Time frame: From enrollment to the end of treatment at 12 weeks
Upper limb strength
Time frame: From enrollment to the end of treatment at 12 weeks
Speed-agility
Time frame: From enrollment to the end of treatment at 12 weeks
Anthropometric characteristics
Time frame: From enrollment to the end of treatment at 12 weeks
Body weight
Time frame: From enrollment to the end of treatment at 12 weeks
Standing height
Time frame: From enrollment to the end of treatment at 12 weeks
Waist girth
Time frame: From enrollment to the end of treatment at 12 weeks
Hip girth
Time frame: From enrollment to the end of treatment at 12 weeks
Body mass index z-score (BMI z-score)
Time frame: From enrollment to the end of treatment at 12 weeks
Waist-to-hip ratio
Time frame: From enrollment to the end of treatment at 12 weeks
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 19 Feb 2026.
- Individual participant dataSharing planned: Undecided
Related trials for Children
Not yet recruiting
Executive Function Play Opportunities for Children With Down Syndrome
Down Syndrome, Trisomy 21
Recruiting
Comparison of Uncomplicated Candidemia Therapy Duration in Children and Adults
Invasive Candidiasis
RecruitingObservational study
Psychotherapy for Irritability in Youth: Comparing Active Treatment to Nonactive Psychoeducation Supportive Psychotherapy
Irritability, Disruptive Mood Dysregulation Disorder
RecruitingPhase 1
A Clinical Study of Letermovir (MK-8228) in Children and Adolescents Who Receive a Kidney Transplant (KT) (MK-8228-077)
Cytomegalovirus Prophylaxis
Active, not recruiting
Chicago Parent Program for Foster and Kinship Caregivers
Behavior Problem, Parenting
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.
Matteo Vandoni principal investigator
University of Pavia
Questions about this trial
What is this clinical trial studying?
A study testing Teacher-led Active Breaks and Video-guided Active Breaks in people with Children, run by University of Pavia.
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 3 inclusion and 3 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: opening soon, as of the sponsor's last update on 19 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
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 Matteo Vandoni (0382987166, matteo.vandoni@unipv.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Perceived enjoyment of physical activity (time frame: From enrollment to the end of treatment at 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 19 Feb 2026.