IDIAPJGol
Barcelona, 08007, Spain
NCT Number: NCT07737548
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.
This study is active but is not currently recruiting participants.
8 year–12 year
All sexes
Interventional
Not applicable
Barcelona, 08007, Spain
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
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
Exclusion criteria
Teacher focus-group eligibility:
Inclusion criteria
Exclusion criteria
A four-month multicomponent school-based behavioural intervention consisting of 15 minutes of physical activity during each school day, supported by a gamified digital platform, collective progress monitoring, educational health messages and motivational rewards.
Time frame: 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.
Time frame: Baseline and immediately after the four-month intervention
Mediterranean diet adherence will be measured using the KIDMED 2.0 questionnaire. The total score and its interpretation will be calculated according to the validated scoring instructions. Higher scores are expected to indicate greater adherence to a Mediterranean dietary pattern.
Time frame: Baseline and immediately after the four-month intervention
Fruit consumption will be assessed using the specific fruit-consumption questions included in the study questionnaire and reported as the average number of fruit servings consumed per day. Higher values indicate greater daily fruit consumption.
Time frame: Baseline and immediately after the four-month intervention
Water intake will be assessed using the specific hydration questions included in the study questionnaire and reported as the average number of glasses of water consumed per day. Higher values indicate greater daily water intake.
Time frame: Baseline and immediately after the four-month intervention
Sleep-related problems will be assessed using the BEARS Sleep Screening Tool, covering bedtime problems, excessive daytime sleepiness, awakenings during the night, regularity and duration of sleep, and snoring. Outcomes will be calculated according to the prespecified study scoring approach.
Time frame: Baseline and immediately after the four-month intervention
Average sleep duration will be reported in hours per night based on responses to the study sleep questionnaire. Higher values indicate longer sleep duration.
Time frame: Baseline and immediately after the four-month intervention
Health-related quality of life and emotional well-being will be measured using KIDSCREEN-10. Scores will be calculated according to the validated scoring procedure. Higher scores indicate better health-related quality of life.
Time frame: Continuously during the four-month intervention
The web platform will automatically record the number of physical activity sessions registered by each participating class and school during the four-month intervention.
Time frame: Throughout the four-month intervention
Intervention adherence will be calculated as the number or percentage of eligible school days on which a participating class registers completion of the planned 15-minute physical activity session.
Time frame: Throughout the four-month intervention
Platform engagement will be assessed using automatically recorded indicators, including the number of educational videos viewed, number of Olympic cities unlocked, progression through the gamified journey and frequency of platform use.
Time frame: Immediately after completion of the four-month intervention
Acceptability and feasibility will be explored through post-intervention focus groups with participating children and teachers from intervention schools. Topics will include satisfaction, perceived benefits, barriers to implementation, use of the platform, integration into school routines and suggestions for improvement. Audio recordings will be transcribed, pseudonymized and analysed using thematic analysis.
Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina
Other
Escola Olímpica: Intervenció Escolar Per a l'Increment de l'Activitat física i d'hàbits Saludables Dels Infants a través de la gamificació
Acronym: OLYMPIC-S
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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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