O 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 and ponderal status.
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.
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.
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Tipo de estudo
Inscrição (Real)
Estágio
- Não aplicável
Contactos e Locais
Locais de estudo
-
-
Pavia
-
Pavia, Pavia, Itália, 27100
- Laboratory of Adapted Motor Activity
-
-
Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Descrição
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.
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Dobro
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
|
Sem intervenção: Rotina habitual
|
|
|
Experimental: Pausas Ativas Guiadas por Vídeo
|
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: Pausas Ativas Orientadas pelo Professor
|
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. |
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Perceived enjoyment of physical activity
Prazo: 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 mean PACES score (unit: questionnaire score) from baseline (Week 0) to post-intervention (Week 12). |
From enrollment to the end of treatment at 12 weeks
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Motor competence
Prazo: 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. |
From enrollment to the end of treatment at 12 weeks
|
|
Objectively measured physical activity
Prazo: 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. |
From enrollment to the final week of treatment at 11 weeks
|
|
Perceived motor competence
Prazo: 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. |
From enrollment to the end of treatment at 12 weeks
|
|
Objectively measured sleep continuity
Prazo: From enrollment to the end of treatment at 12 weeks
|
Sleep will be objectively assessed from accelerometer data processed using the GGIR package. Sleep continuity 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
Prazo: 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. |
From enrollment to the end of treatment at 12 weeks
|
|
Upper limb explosive strength
Prazo: 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. |
From enrollment to the end of treatment at 12 weeks
|
|
Upper limb strength
Prazo: 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. |
From enrollment to the end of treatment at 12 weeks
|
|
Speed-agility
Prazo: 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. |
From enrollment to the end of treatment at 12 weeks
|
|
Anthropometric characteristics
Prazo: 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. |
From enrollment to the end of treatment at 12 weeks
|
|
Body weight
Prazo: 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. |
From enrollment to the end of treatment at 12 weeks
|
|
Standing height
Prazo: 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. |
From enrollment to the end of treatment at 12 weeks
|
|
Waist girth
Prazo: 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. |
From enrollment to the end of treatment at 12 weeks
|
|
Hip girth
Prazo: 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. |
From enrollment to the end of treatment at 12 weeks
|
|
Body mass index z-score (BMI z-score)
Prazo: 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. |
From enrollment to the end of treatment at 12 weeks
|
|
Waist-to-hip ratio
Prazo: 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. |
From enrollment to the end of treatment at 12 weeks
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Matteo Vandoni, University of Pavia
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Real)
Conclusão Primária (Real)
Conclusão do estudo (Real)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Outros números de identificação do estudo
- PLAY-IC-2025
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
Descrição do plano IPD
De-identified individual participant data underlying the published results, together with the corresponding data dictionary, will be made available to qualified researchers upon reasonable request to the Principal Investigator, Prof. Matteo Vandoni, University of Pavia, following publication of the primary trial findings. Data sharing will be subject to scientific review, applicable ethical and data protection requirements, and a data use agreement where appropriate.
Informações sobre medicamentos e dispositivos, documentos de estudo
Estuda um medicamento regulamentado pela FDA dos EUA
Estuda um produto de dispositivo regulamentado pela FDA dos EUA
Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .