Denne side blev automatisk oversat, og nøjagtigheden af ​​oversættelsen er ikke garanteret. Der henvises til engelsk version for en kildetekst.

B4B Evolution Type II Hybrid Effectiveness-Implementation Trial (B4B Evolution)

21. juli 2026 opdateret af: University of the Balearic Islands

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.

Studieoversigt

Status

Tilmelding efter invitation

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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.

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

300

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Spanien
    • Spain
      • Palma, Spain, Spanien, 07122
        • Faculty of Education

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Barn

Tager imod sunde frivillige

Ja

Beskrivelse

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.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Andet
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Break4Brain Evolution intervention
Schools allocated to this arm will implement the B4B Evolution classroom movement programme from October 2026 throughout the academic year.
Adfærdsmæssigt: Break4Brain Evolution
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.
Ingen indgriben: 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.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Tidsramme
Change From Baseline in Everyday Executive Function Measured by the BRIEF-2 Teacher Form
Tidsramme: Baseline and Month 9
Baseline and Month 9
Change From Baseline in Academic Achievement Measured by the Woodcock-Muñoz Battery
Tidsramme: Baseline, Month 9, and Month 15
Baseline, Month 9, and Month 15
Change From Baseline in Processing Speed, Inhibition, and Cognitive Flexibility Measured by the Five Digit Test
Tidsramme: Baseline, Month 9, and Month 15
Baseline, Month 9, and Month 15
Change From Baseline in Selective Attention and Concentration Measured by the d2 Test of Attention
Tidsramme: Baseline and Month 9
Baseline and Month 9

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change From Baseline in Habitual Physical Activity Measured by the Physical Activity Questionnaire for Children
Tidsramme: Baseline, Month 9, and Month 15
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.
Baseline, Month 9, and Month 15
Change From Baseline in Daily Moderate-to-Vigorous Physical Activity Measured by ActiGraph Accelerometry
Tidsramme: Baseline, and Month 9
Baseline, and Month 9
Change From Baseline in Daily Sedentary Time Measured by ActiGraph Accelerometry
Tidsramme: Baseline, and Month 9
Baseline, and Month 9
Change From Baseline in Daily Sleep Duration Measured by ActiGraph Accelerometry
Tidsramme: Baseline, and Month 9
Baseline, and Month 9
Percentage of B4B Evolution Session Time Spent in Moderate-to-Vigorous Physical Activity
Tidsramme: Month 5
Month 5

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

University of the Balearic Islands

Samarbejdspartnere

State Research Agency, Spain

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Hjælpsomme links

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Anslået)

15. september 2026

Primær færdiggørelse (Anslået)

30. september 2026

Studieafslutning (Anslået)

30. juni 2027

Datoer for studieregistrering

Først indsendt

13. juli 2026

Først indsendt, der opfyldte QC-kriterier

21. juli 2026

Først opslået (Faktiske)

24. juli 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

24. juli 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

21. juli 2026

Sidst verificeret

1. juli 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • B4BEVO-EFF-01
  • PID2024-156331OB-I00 (Andet bevillings-/finansieringsnummer: Agencia Estatal de Investigación (AEI), Ministerio de Ciencia, Innovación y Universidades)

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

JA

IPD-planbeskrivelse

De-identified individual participant data underlying the results reported in study publications may be made available to qualified researchers upon reasonable request. Data sharing will be subject to approval by the study team and to applicable ethical, institutional, and data-protection requirements. Data will not be made publicly available because of the potential risk of identifying participating students, teachers, and schools.

IPD-delingstidsramme

Data will be available beginning 12 months after publication of the main study results and for 5 years thereafter.

IPD-delingsadgangskriterier

Requests must be submitted to the corresponding investigator and include a scientifically sound research proposal, the objectives of the proposed analyses, the data requested, and a data-management plan. Access will be granted only after review and approval by the study team and, where required, the relevant ethics committee or institutional authority. Researchers receiving data will be required to sign a data-use agreement and use the data only for the approved purpose.

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ingen

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Kliniske forsøg med Fysisk aktivitet

Kliniske forsøg med Break4Brain Evolution

Søg i lignende forsøg

Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

CROs by country

CROs in Mongolia

Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

Abonner