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

28 juli 2026 bijgewerkt door: 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.

Studie Overzicht

Toestand

Aanmelden op uitnodiging

Conditie

Interventie / Behandeling

Gedetailleerde beschrijving

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.

Studietype

Ingrijpend

Inschrijving (Geschat)

300

Fase

  • Niet toepasbaar

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studie Locaties

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

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

  • Kind

Accepteert gezonde vrijwilligers

Ja

Beschrijving

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.

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Ander
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Geen (open label)

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: Break4Brain Evolution intervention
Schools allocated to this arm will implement the B4B Evolution classroom movement programme from October 2026 throughout the academic year.
Gedragsmatig: 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.
Geen tussenkomst: 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.

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Tijdsspanne
Change From Baseline in Everyday Executive Function Measured by the BRIEF-2 Teacher Form
Tijdsspanne: Baseline and Month 9
Baseline and Month 9
Change From Baseline in Academic Achievement Measured by the Woodcock-Muñoz Battery
Tijdsspanne: 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
Tijdsspanne: Baseline and Month 9
Baseline and Month 9
Change From Baseline in Processing Speed, Inhibition, and Cognitive Flexibility Measured by the Trail Making Test
Tijdsspanne: Baseline, Month 9, and Month 15
Baseline, Month 9, and Month 15

Secundaire uitkomstmaten

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

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

University of the Balearic Islands

Medewerkers

State Research Agency, Spain

Publicaties en nuttige links

De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.

Nuttige links

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Geschat)

15 september 2026

Primaire voltooiing (Geschat)

30 september 2026

Studie voltooiing (Geschat)

30 juni 2027

Studieregistratiedata

Eerst ingediend

13 juli 2026

Eerst ingediend dat voldeed aan de QC-criteria

21 juli 2026

Eerst geplaatst (Werkelijk)

24 juli 2026

Updates van studierecords

Laatste update geplaatst (Werkelijk)

30 juli 2026

Laatste update ingediend die voldeed aan QC-criteria

28 juli 2026

Laatst geverifieerd

1 juli 2026

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

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

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

JA

Beschrijving IPD-plan

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-tijdsbestek voor delen

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

IPD-toegangscriteria voor delen

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.

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

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