Health TrialsbyHealthPanel

The Pause, Learn, and Activate Yourself (PLAY)

ConditionChildren
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age5-12
SponsorUniversity of Pavia

About this 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.

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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.

Disqualifiers

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 design

Design model

Parallel

Treatments tested in this trial

  • Teacher-led Active Breaks

    Other intervention

    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 Breaks

    Other intervention

    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.

Treatment groups

810 Participants
are divided into 3 treatment groups
Group A: Usual routineNo intervention 0 interventions
Group B: Video-guided Active BreaksExperimental treatment 1 intervention
Group C: Teacher-led Active BreaksExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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).

Time frame
From enrollment to the end of treatment at 12 weeks

Secondary outcomes

1

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.

Time frame
From enrollment to the end of treatment at 12 weeks
2

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.

Time frame
From enrollment to the final week of treatment at 11 weeks
3

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.

Time frame
From enrollment to the end of treatment at 12 weeks
4

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.

Time frame
From enrollment to the end of treatment at 12 weeks

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Pavia

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: