The Pause, Learn, and Activate Yourself (PLAY)

NCT07421128 | Not Yet Recruiting

• 1 other identifier: PLAY-IC-2025
• Study Type: interventional
• Target: 810
• Locations: 0 countries
• Sites: N/A

Brief 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. 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.

Conditions

Children

Outcome Measures

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).

  From enrollment to the end of treatment at 12 weeks

Secondary Outcomes (16)

• Motor competence

  From enrollment to the end of treatment at 12 weeks

• Objectively measured physical activity

  From enrollment to the final week of treatment at 11 weeks

• Perceived motor competence

  From enrollment to the end of treatment at 12 weeks

• Physical fitness

  From enrollment to the end of treatment at 12 weeks

• Objectively measured sleep quality

  From enrollment to the end of treatment at 12 weeks

Study Arms (3)

Usual routine

NO INTERVENTION

Video-guided Active Breaks

EXPERIMENTAL

Other: Video-guided Active Breaks

Teacher-led Active Breaks

EXPERIMENTAL

Other: Teacher-led Active Breaks

Interventions

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.

Teacher-led Active Breaks

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.

Video-guided Active Breaks

Eligibility Criteria

• Age: 5 Years - 12 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Pavia: lead

Study Officials

• Matteo Vandoni

  University of Pavia

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Matteo Vandoni

CONTACT

0382987166; matteo.vandoni@unipv.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: January 19, 2026
• First Posted: February 19, 2026
• Study Start: February 16, 2026
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): September 15, 2026
• Last Updated: February 19, 2026

Record last verified: 2026-02