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Active, Not Recruiting

NCT Number: NCT07737548

OLYMPIC-S: Outcomes of a Life-stYle Multicomponent Physical-activity Intervention in Children - School-based Randomized Controlled Trial

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Age range

8 year–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

IDIAPJGol

Barcelona, 08007, Spain

About this study

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.

Who can participate

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

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

Olympic School

Behavioral

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.

Primary outcomes

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

    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.

Secondary outcomes

  1. Change From Baseline in Mediterranean Diet Adherence at 4 Months

    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.

  2. Change From Baseline in Fruit Consumption at 4 Months

    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.

  3. Change From Baseline in Water Intake at 4 Months

    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.

  4. Change From Baseline in Sleep-Related Problems at 4 Months

    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.

  5. Change From Baseline in Sleep Duration at 4 Months

    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.

  6. Change From Baseline in Health-Related Quality of Life at 4 Months

    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.

  7. Number of School Physical Activity Sessions Completed During the Intervention

    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.

  8. Adherence to the Olympic School 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.

  9. Engagement With the Gamified Web Platform

    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.

Other outcomes

  1. Acceptability and Feasibility of the Escola Olímpica Intervention

    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.

Sponsors and collaborators

Lead sponsor

Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina

Other

Collaborators

  • Department of Health, Generalitat de Catalunya

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2026
Study completion
2027
First posted
Jul 30, 2026
Registry last updated
Jul 30, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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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