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临床试验/NCT07737548
NCT07737548进行中(未招募)不适用

Escola Olímpica: Intervenció Escolar Per a l'Increment de l'Activitat física i d'hàbits Saludables Dels Infants a través de la gamificació

Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina1 个研究点 分布在 1 个国家目标入组 893 人开始时间: 2026年2月2日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
进行中(未招募)
发起方
入组人数
893
试验地点
1
主要终点
Change From Baseline in Daily Moderate-to-Vigorous Physical Activity at 4 Months

研究概览

简要总结

OLYMPIC-S is a cluster randomized controlled trial evaluating a four-month school-based intervention designed to increase moderate-to-vigorous physical activity and promote healthy habits among children in the fourth, fifth and sixth grades of primary school. Fifteen schools and approximately 1,200 children will participate. Schools will be randomized to the Olympic School intervention or to a control group continuing usual school activities.

Intervention schools will introduce 15 minutes of physical activity during each school day. Teachers may choose between outdoor walking or running activities based on The Daily Mile or structured movement video sessions from the Born to Move programme. A gamified web platform will record the activity performed, display each school's collective progress through an Olympic journey, unlock educational content and reinforce messages related to physical activity, healthy eating, hydration and sleep.

Outcomes will be assessed at baseline and immediately after the four-month intervention. The primary outcome is daily moderate-to-vigorous physical activity measured using the PAU-7S questionnaire. Secondary outcomes include dietary habits, fruit and water consumption, sleep, emotional well-being, health-related quality of life, adherence, platform use, feasibility and acceptability. Post-intervention focus groups with children and teachers will complement the quantitative evaluation.

详细描述

Regular physical activity is important for children's physical and emotional development, but many children do not achieve recommended physical activity levels. Schools provide an appropriate environment for introducing regular opportunities for movement and for promoting healthy behaviours. Olympic School programme combines a brief daily physical activity component with gamification and health-promotion messages intended to support participation and sustained engagement.

This study will use a two-arm cluster randomized controlled design, with the school as the unit of randomization. Fifteen primary schools will be allocated to the intervention or control condition. Children in the fourth, fifth and sixth grades whose parents or legal guardians provide informed consent and who provide assent will be invited to participate in the study assessments.

For four months, intervention schools will incorporate 15 minutes of physical activity into each school day. Schools may select the time of day that is most compatible with their routine. Teachers may conduct outdoor walking or running sessions based on The Daily Mile programme or use structured movement video sessions from the Born to Move programme. The intervention is supported by a gamified web platform presenting participation as a collective journey towards the Olympic Games. The platform records activity minutes, displays progress, unlocks Olympic cities and educational content, and provides brief messages relating to physical activity, diet, hydration and sleep. Control schools will continue their usual school activities and will not have access to the intervention platform during the study period.

Quantitative assessments will be completed at baseline and immediately after the four-month intervention. The primary outcome will be moderate-to-vigorous physical activity measured using PAU-7S. Secondary outcomes will assess Mediterranean diet adherence, fruit and water consumption, sleep, emotional well-being and health-related quality of life. Platform data will be collected throughout the intervention to evaluate implementation and adherence.

Quantitative analyses will follow the intention-to-treat principle. Mixed-effects models will account for repeated measurements and the clustering of participants within schools and will include study group, time, the group-by-time interaction and baseline outcome values. Sensitivity analyses will assess the effect of missing data. Post-intervention focus groups with children and teachers from intervention schools will explore acceptability, perceived benefits, implementation barriers and opportunities for improvement. Qualitative data will be analysed thematically and integrated with the quantitative and platform-use findings.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
None

入排标准

年龄范围
8 Years 至 12 Years(Child)
性别
All
接受健康志愿者

入选标准

  • The intervention content is intended for approximately 8-12-year-old children, but the actual lower and upper age limits should be based on the expected ages of pupils in the participating fourth-, fifth- and sixth-grade classes.
  • Inclusion Criteria:
  • Enrolled in the fourth, fifth or sixth grade at a participating primary school.
  • Parent or legal guardian has provided written informed consent.
  • Child has provided informed assent.
  • Child is able to complete the study questionnaires with the support normally available during classroom administration.
  • Child is expected to remain enrolled at the participating school throughout the four-month intervention period.

排除标准

  • Written parental or legal-guardian consent has not been obtained.
  • The child does not provide assent or withdraws assent.
  • The child cannot participate in the study assessments according to the criteria established in the approved protocol.
  • Teacher focus-group eligibility:
  • Inclusion criteria:
  • Teachers or other school staff who directly participated in implementing Olympic School at an intervention school and who provide written informed consent.
  • Exclusion criteria:
  • Teachers or school staff who did not participate directly in implementation or who do not consent to the audio-recorded focus group.

研究组 & 干预措施

Olympic School intervention

Experimental

Schools allocated to the experimental group will implement the Olympic School programme for four months. On each school day, participating classes will undertake 15 minutes of teacher-led physical activity. Teachers may choose between outdoor walking or running based on The Daily Mile principles or structured movement video sessions from Born to Move programme. The activity will be supported by a gamified web platform that records activity minutes, displays collective progress through an Olympic journey, unlocks cities and educational materials, and presents brief health messages concerning physical activity, fruit consumption, hydration and sleep. Schools will also receive a physical progress poster and symbolic recognition will be provided at the end of the programme.

干预措施: Olympic School (Behavioral)

Usual School Activities

No Intervention

Schools allocated to the control group will continue their usual educational and physical activity practices. They will not have access to the Olympic School web platform during the four-month study period.

结局指标

主要结局

Change From Baseline in Daily Moderate-to-Vigorous Physical Activity at 4 Months

时间窗: Baseline and immediately after the four-month intervention

Moderate-to-vigorous physical activity will be assessed using the PAU-7S questionnaire. The outcome will be expressed as the estimated mean number of minutes per day spent in moderate-to-vigorous physical activity. Higher values indicate more physical activity. The primary comparison will be the adjusted difference in change from baseline between intervention and control groups, accounting for the clustering of participants within schools.

次要结局

  • Change From Baseline in Mediterranean Diet Adherence at 4 Months(Baseline and immediately after the four-month intervention)
  • Change From Baseline in Fruit Consumption at 4 Months(Baseline and immediately after the four-month intervention)
  • Change From Baseline in Water Intake at 4 Months(Baseline and immediately after the four-month intervention)
  • Change From Baseline in Sleep-Related Problems at 4 Months(Baseline and immediately after the four-month intervention)
  • Change From Baseline in Sleep Duration at 4 Months(Baseline and immediately after the four-month intervention)
  • Change From Baseline in Health-Related Quality of Life at 4 Months(Baseline and immediately after the four-month intervention)
  • Number of School Physical Activity Sessions Completed During the Intervention(Continuously during the four-month intervention)
  • Adherence to the Olympic School Intervention(Throughout the four-month intervention)
  • Engagement With the Gamified Web Platform(Throughout the four-month intervention)

研究者

发起方
Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina
申办方类型
Other
责任方
Sponsor

研究点 (1)

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