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NCT Number: NCT07421128

The Pause, Learn, and Activate Yourself (PLAY)

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.

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Key information

Conditions

Age range

5 year–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

Teacher-led Active Breaks

Other

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

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.

Primary outcomes

  1. 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).

Secondary outcomes

  1. Motor competence

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

    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.

  2. Objectively measured physical activity

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

    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.

  3. Perceived motor competence

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

    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.

  4. Physical fitness

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

    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.

  5. Objectively measured sleep quality

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

    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.

  6. Lower-limb explosive strength

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

    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.

  7. Upper limb explosive strength

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

    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.

  8. Upper limb strength

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

    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.

  9. Speed-agility

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

    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.

  10. Anthropometric characteristics

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

    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.

  11. Body weight

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

    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.

  12. Standing height

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

    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.

  13. Waist girth

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

    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.

  14. Hip girth

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

    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.

  15. Body mass index z-score (BMI z-score)

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

    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.

  16. Waist-to-hip ratio

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

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Matteo Vandoni

CONTACT

[email protected]

0382987166

Sponsors and collaborators

Lead sponsor

University of Pavia

Other

Registry information

Official study title

Active Breaks in School: The Pause, Learn, and Activate Yourself (PLAY) Cluster-Randomized Controlled Trial

Acronym: PLAY

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Feb 19, 2026
Registry last updated
Feb 19, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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