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OLYMPIC-S: Outcomes of a Life-stYle Multicomponent Physical-activity Intervention in Children at School (OLYMPIC-S)

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

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.

연구 개요

상태

모집하지 않고 적극적으로

개입 / 치료

상세 설명

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.

연구 유형

중재적

등록 (실제)

893

단계

  • 해당 없음

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 장소

    • Barcelona
      • Barcelona, Barcelona, 스페인, 08007
        • IDIAPJGol

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

  • 어린이

건강한 자원 봉사자를 받아들입니다

예

설명

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.

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 방지
  • 할당: 무작위
  • 중재 모델: 병렬 할당
  • 마스킹: 없음(오픈 라벨)

무기와 개입

참가자 그룹 / 팔
개입 / 치료
실험적: Olympic School intervention
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.
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.
간섭 없음: Usual School Activities
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.

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Change From Baseline in Daily Moderate-to-Vigorous Physical Activity at 4 Months
기간: 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.
Baseline and immediately after the four-month intervention

2차 결과 측정

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

기타 결과 측정

결과 측정
측정값 설명
기간
Acceptability and Feasibility of the Escola Olímpica Intervention
기간: 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.
Immediately after completion of the four-month intervention

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (실제)

2026년 2월 2일

기본 완료 (추정된)

2026년 9월 1일

연구 완료 (추정된)

2027년 6월 30일

연구 등록 날짜

최초 제출

2026년 7월 27일

QC 기준을 충족하는 최초 제출

2026년 7월 27일

처음 게시됨 (실제)

2026년 7월 30일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2026년 7월 31일

QC 기준을 충족하는 마지막 업데이트 제출

2026년 7월 30일

마지막으로 확인됨

2026년 7월 1일

추가 정보

이 연구와 관련된 용어

개별 참가자 데이터(IPD) 계획

개별 참가자 데이터(IPD)를 공유할 계획입니까?

미정

IPD 계획 설명

Individual participant data are not currently planned for public sharing because the study involves minors and school-level clusters, which may create a risk of participant or school re-identification. Aggregated and anonymized study findings will be disseminated through scientific publications and project reports. Requests for access to suitably de-identified data may be considered in accordance with the informed consent, ethics approval, data protection legislation and the PREVENT Data Management Plan.

약물 및 장치 정보, 연구 문서

미국 FDA 규제 의약품 연구

아니

미국 FDA 규제 기기 제품 연구

아니

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .

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