The Pause, Learn, and Activate Yourself (PLAY) (PLAY)

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.

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 Overview

• Status: Not yet recruiting
• Conditions: Children
• Intervention / Treatment: Other: Video-guided Active Breaks; Other: Teacher-led Active Breaks

• Study Type: Interventional
• Enrollment (Estimated): 810
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Matteo Vandoni; Phone Number: 0382987166; Email: matteo.vandoni@unipv.it

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Usual routine
Experimental: Video-guided Active Breaks	Other: Video-guided Active Breaks; 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.
Experimental: Teacher-led Active Breaks	Other: Teacher-led Active Breaks; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	From enrollment to the end of treatment at 12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	From enrollment to the end of treatment at 12 weeks

Collaborators and Investigators

• Sponsor: University of Pavia
• Investigators: Principal Investigator: Matteo Vandoni, University of Pavia

Study record dates

Study Major Dates

• Study Start (Estimated): February 16, 2026
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): September 15, 2026

Study Registration Dates

• First Submitted: January 19, 2026
• First Submitted That Met QC Criteria: February 16, 2026
• First Posted (Actual): February 19, 2026

Study Record Updates

• Last Update Posted (Actual): February 19, 2026
• Last Update Submitted That Met QC Criteria: February 16, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: PLAY-IC-2025

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No