- ICH GCP
- Registr klinických studií v USA
- Klinická studie NCT07726732
B4B Evolution Type II Hybrid Effectiveness-Implementation Trial (B4B Evolution)
Classroom Movement Strategies to Increase Physical Activity and Improve Cognition and Academic Performance in a School-Aged Population: Protocol for the Break4Brain Type II Hybrid Effectiveness-Implementation Trial
Break4Brain Evolution is a school-based programme designed to help teachers incorporate brief, safe and inclusive movement activities into normal classroom routines. The study aims to examine both how the programme is adopted and delivered in real-world schools and whether it improves students' physical activity, attention, executive functions and academic achievement.
This is a type II hybrid implementation-effectiveness study with two complementary components. The implementation component will examine the scale-up of Break4Brain Evolution across at least 50 preschool, primary and secondary schools in the Balearic Islands and mainland Spain. Information from school leaders, teachers and students will be used to assess programme reach, adoption, acceptability, feasibility, appropriateness, fidelity, adaptations and maintenance.
The effectiveness component is an embedded cluster-randomized controlled trial conducted in six primary schools in Mallorca. Schools will be randomly allocated to either the Break4Brain Evolution programme or usual school practice, with three schools in each group. Two classrooms from each school, one grade 5 and one grade 6 classroom, will participate, resulting in an estimated sample of 300 students.
Baseline assessments will be conducted in September 2026. Schools allocated to the intervention group will begin implementing Break4Brain Evolution in October 2026 and will use the programme during the academic year. Follow-up assessments will be conducted in February 2027, June 2027 and December 2027.
Přehled studie
Postavení
Intervence / Léčba
Detailní popis
Break4Brain Evolution is a digitally supported behavioural and environmental intervention designed to introduce movement into routine classroom practice. The programme provides teachers with structured but flexible resources that can be adapted to different classroom needs, curricular demands, available space and school contexts.
The programme includes four main movement typologies: active videos, physically active learning activities, an active card game and movement activities proposed or adapted by teachers. All programme components are provided through the Break4Brain digital platform, which includes training materials, classroom resources, implementation planning tools, a teacher forum, a resource bank, monitoring procedures and communication with the research team.
Study design
The study uses a type II hybrid implementation-effectiveness design to concurrently evaluate the implementation, scale-up and effectiveness of Break4Brain Evolution under real-world school conditions. The study includes a large-scale implementation component and an embedded effectiveness trial.
Implementation component
The implementation component will examine the delivery and scale-up of Break4Brain Evolution across preschool, primary and secondary schools in the Balearic Islands and mainland Spain. The objective is for the programme to be adopted by at least 50 schools, with a minimum of two classrooms participating in each school.
School leaders, teachers and students will contribute information related to Reach, Adoption, Implementation and Maintenance. Implementation outcomes will include school and teacher participation, training completion, digital platform engagement, use of programme resources, classroom movement delivery, intervention dose, fidelity, adaptations, acceptability, appropriateness, feasibility, barriers and facilitators, implementation leadership, implementation climate and sustained programme use.
Implementation will be supported through teacher training, multiple dissemination channels, free access to a digital platform, flexible and context-sensitive delivery, use of existing school resources, monitoring and feedback, an online support network and resources intended to support long-term sustainability.
Effectiveness component
The effectiveness study will use a cluster-randomized controlled trial design, with schools as the unit of randomization. Six primary schools in Mallorca will be included. Three schools will be allocated to the intervention group and three schools to the control group.
Two classrooms will be recruited from each school, including one grade 5 and one grade 6 classroom. The effectiveness sample will therefore include 12 classrooms and an estimated 300 students.
Schools allocated to the intervention group will implement Break4Brain Evolution from October 2026 and throughout the academic year. Teachers will select and adapt movement activities according to their classroom context while preserving the core purpose of introducing brief, safe and inclusive movement opportunities into classroom routines.
Schools allocated to the control group will continue with usual school practice and will not have access to the Break4Brain Evolution programme during the intervention period.
Data collection
Baseline assessments for the effectiveness trial will be conducted in September 2026, before the intervention begins. Subsequent assessments will take place in February 2027, June 2027 and December 2027.
Programme effectiveness will be evaluated through changes in students' physical activity, attention, executive functions and academic achievement. Mixed-methods data will be collected at school, teacher and student levels using digital platform metrics, questionnaires, accelerometry, academic and cognitive assessments, interviews and focus groups.
The December 2027 assessment will examine maintenance of the programme and the extent to which schools and teachers continue to integrate classroom movement into routine educational practice.
Typ studie
Zápis (Odhadovaný)
Fáze
- Nelze použít
Kontakty a umístění
Studijní místa
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Spain
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Palma, Spain, Španělsko, 07122
- Faculty of Education
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Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
- Dítě
Přijímá zdravé dobrovolníky
Popis
Inclusion Criteria:
- Children aged 10 to 12 years.
- Enrolled in Grade 5 or Grade 6 in a classroom participating in the cluster-randomized controlled trial.
- Written informed consent provided by a parent or legal guardian.
- Assent provided by the child.
Exclusion Criteria:
- Presence of a physical impairment.
- Failure to provide parental or legal guardian informed consent.
- Failure to provide child assent.
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Jiný
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Žádné (otevřený štítek)
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
|---|---|
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Experimentální: Break4Brain Evolution intervention
Schools allocated to this arm will implement the B4B Evolution classroom movement programme from October 2026 throughout the academic year.
|
B4B Evolution is a digitally supported school-based classroom movement programme.
Teachers receive training and access to a digital platform containing active videos, physically active learning activities, an active card game, and movement activities that can be proposed or adapted by teachers.
The programme is designed to integrate brief, safe, and inclusive movement opportunities into usual classroom routines.
Schools assigned to the intervention arm will begin implementing the programme in October 2026 and will continue throughout the academic year.
Teachers may adapt activities to the classroom context while maintaining the core components of the programme.
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Žádný zásah: Usual school practice
Schools allocated to this arm will continue their usual school practices and will not receive access to the B4B Evolution programme during the intervention period.
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Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Časové okno |
|---|---|
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Change From Baseline in Everyday Executive Function Measured by the BRIEF-2 Teacher Form
Časové okno: Baseline and Month 9
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Baseline and Month 9
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Change From Baseline in Academic Achievement Measured by the Woodcock-Muñoz Battery
Časové okno: Baseline, Month 9, and Month 15
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Baseline, Month 9, and Month 15
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Change From Baseline in Processing Speed, Inhibition, and Cognitive Flexibility Measured by the Five Digit Test
Časové okno: Baseline, Month 9, and Month 15
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Baseline, Month 9, and Month 15
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Change From Baseline in Selective Attention and Concentration Measured by the d2 Test of Attention
Časové okno: Baseline and Month 9
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Baseline and Month 9
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Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Change From Baseline in Habitual Physical Activity Measured by the Physical Activity Questionnaire for Children
Časové okno: Baseline, Month 9, and Month 15
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Habitual physical activity during the previous 7 days will be assessed using the Physical Activity Questionnaire for Older Children (PAQ-C).
The overall PAQ-C score is calculated as the mean of 9 scored items.
Scores range from 1 to 5, with higher scores indicating higher levels of habitual physical activity and therefore a better outcome.
Between-group differences in change from baseline will be evaluated.
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Baseline, Month 9, and Month 15
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Change From Baseline in Daily Moderate-to-Vigorous Physical Activity Measured by ActiGraph Accelerometry
Časové okno: Baseline, and Month 9
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Baseline, and Month 9
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Change From Baseline in Daily Sedentary Time Measured by ActiGraph Accelerometry
Časové okno: Baseline, and Month 9
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Baseline, and Month 9
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Change From Baseline in Daily Sleep Duration Measured by ActiGraph Accelerometry
Časové okno: Baseline, and Month 9
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Baseline, and Month 9
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Percentage of B4B Evolution Session Time Spent in Moderate-to-Vigorous Physical Activity
Časové okno: Month 5
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Month 5
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Spolupracovníci a vyšetřovatelé
Spolupracovníci
Publikace a užitečné odkazy
Užitečné odkazy
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Odhadovaný)
Primární dokončení (Odhadovaný)
Dokončení studie (Odhadovaný)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Klíčová slova
Další relevantní podmínky MeSH
Další identifikační čísla studie
- B4BEVO-EFF-01
- PID2024-156331OB-I00 (Jiné číslo grantu/financování: Agencia Estatal de Investigación (AEI), Ministerio de Ciencia, Innovación y Universidades)
Plán pro data jednotlivých účastníků (IPD)
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Popis plánu IPD
Časový rámec sdílení IPD
Kritéria přístupu pro sdílení IPD
Informace o lécích a zařízeních, studijní dokumenty
Studuje lékový produkt regulovaný americkým FDA
Studuje produkt zařízení regulovaný americkým úřadem FDA
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