Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12625000510448
Ethics application status
Approved
Date submitted
8/05/2025
Date registered
23/05/2025
Date last updated
23/05/2025
Date data sharing statement initially provided
23/05/2025
Type of registration
Prospectively registered

Titles & IDs
Public title
Physically active micro lessons: Assessing the effect of a time-efficient solution for busy teachers on children's physical literacy
Scientific title
Assessing the feasibility and preliminary efficacy of physically active micro lessons in primary school children. The Burn 2 Learn junior (B2L-j) feasibility trial.
Secondary ID [1] 314410 0
Nil known
Universal Trial Number (UTN)
Trial acronym
B2L-j
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cardio-respiratory fitness 337422 0
Muscular fitness 337423 0
Condition category
Condition code
Cardiovascular 333800 333800 0 0
Normal development and function of the cardiovascular system
Public Health 333801 333801 0 0
Health promotion/education
Musculoskeletal 333874 333874 0 0
Normal musculoskeletal and cartilage development and function

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The current project will examine the feasibility and preliminary efficacy of the Burn 2 Learn junior (B2L-j) intervention in primary schools. The B2L-j intervention involves 'micro lessons', which are designed to be brief structured sessions that involve high levels of physical activity and opportunities for students to practice and refine their foundational movement skills. Micro lessons have been designed to satisfy participants’ basic psychological needs for autonomy, competence, and relatedness, to support autonomous motivation for physical activity.

Classroom teachers will receive training, resources, and support to deliver 2-3 physically active micro lessons per week (lasting ~15 minutes), for 6 weeks. Micro lessons will be delivered by a classroom teacher during individual classes (comprising approximately 25 students). A range of physically active micro lessons and resources will be designed, each with a focus on developing students’ cardiovascular fitness and foundational movement skill competency (e.g., kick, two-hand strike, body-weight squat). Lessons are designed for students to work cooperatively in small groups and will be aligned with physical education curriculum and outcomes (i.e., focus on fundamental movement skills). Micro lessons will provide developmentally appropriate learning experiences for all students by utilising small group-based activities contributing to high active learning time. School will be provided with an equipment pack to support the delivery of micro lessons (e.g., basketballs, cricket bats, tennis balls). Classroom teachers will be provided with training via a face-to-face professional development workshop that has been designed specifically for this study. The workshop will be facilitated by the research team, and take approximately 2 hours. One workshop will be delivered at each of the study schools, 1 week prior to the start of the intervention. During the intervention delivery, the research team will provide ongoing support to the study schools. This will include a weekly check-in via email, and two lesson observations (approximately intervention weeks 2 and 5). Teachers will be provided with a logbook and asked to document when micro lessons have been delivered. This will be discussed during the professional development workshop for teachers.

The concept of physically active micro lessons was informed by Beets et al theory of
expanded, extended and enhanced opportunities (TEO). For the current study, the provision of an entirely new opportunity for physical activity (i.e., expansion) was considered necessary, as few primary schools in NSW reach physical activity mandates.
Intervention code [1] 331017 0
Lifestyle
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 341382 0
Acceptability domain of feasibility.
Timepoint [1] 341382 0
Intervention endpoint (6-weeks post baseline).
Primary outcome [2] 341383 0
Implementation domain of feasibility
Timepoint [2] 341383 0
The number of teacher-reported sessions will be collected post-program. Fidelity observations conducted twice (approx weeks 3 and 6 of the intervention).
Primary outcome [3] 341384 0
Recruitment – the percentage of Stage 3 students that are recruited to participate in the B2L-j program based on the target sample size
Timepoint [3] 341384 0
Cumulative data will be reviewed at the conclusion of recruitment
Secondary outcome [1] 447366 0
Preliminary efficacy - fundamental movement skill (FMS) competence
Timepoint [1] 447366 0
Baseline and intervention endpoint (6-weeks post baseline)
Secondary outcome [2] 447367 0
Preliminary efficacy - perceived competence
Timepoint [2] 447367 0
Baseline and intervention endpoint (6-weeks post baseline)
Secondary outcome [3] 447368 0
Preliminary efficacy - cardiorespiratory fitness
Timepoint [3] 447368 0
Baseline and intervention endpoint (6-weeks post baseline)
Secondary outcome [4] 447371 0
Preliminary efficacy - upper body muscular fitness
Timepoint [4] 447371 0
Baseline and intervention endpoint (6-weeks post baseline)
Secondary outcome [5] 447372 0
Preliminary efficacy - motivation for physical education
Timepoint [5] 447372 0
Baseline and intervention endpoint (6-weeks post baseline)
Secondary outcome [6] 447373 0
Teachers' Capability, Opportunity, and Motivation to deliver Physical Activity in Schools
Timepoint [6] 447373 0
Intervention endpoint (6-weeks post baseline)
Secondary outcome [7] 447785 0
Preliminary efficacy - Lower body muscular fitness
Timepoint [7] 447785 0
Baseline and intervention end-point (6-weeks)

Eligibility
Key inclusion criteria
Stage 3 (i.e., Grades 5 and 6) students and their classroom teachers
Minimum age
10 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
None

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Data for feasibility domains will be analysed using descriptive statistics (i.e., mean, standard deviation, percentages), or qualitatively described where appropriate. Outcomes for preliminary efficacy will be analysed using paired sample t-tests to determine change in mean from baseline to post-test. Analyses will be conducted in IBM SPSS Statistics for Windows (Version 29; 2010 SPSS Inc, IBM Company, Armonk, NY). As this is an unpowered trial, Cohen’s d will be calculated to provide a measure of preliminary efficacy by dividing the mean difference in change (post-test minus baseline) by the standard deviation of change.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
26/05/2025
Actual
Date of last participant enrolment
Anticipated
26/05/2025
Actual
Date of last data collection
Anticipated
4/07/2025
Actual
Sample size
Target
50
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 318932 0
University
Name [1] 318932 0
University of Newcastle
Country [1] 318932 0
Australia
Primary sponsor type
Individual
Name
David R. Lubans - University of Newcastle
Address
Country
Australia
Secondary sponsor category [1] 321401 0
None
Name [1] 321401 0
Address [1] 321401 0
Country [1] 321401 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 317545 0
The University of Newcastle Human Research Ethics Committee
Ethics committee address [1] 317545 0
Ethics committee country [1] 317545 0
Australia
Date submitted for ethics approval [1] 317545 0
13/11/2024
Approval date [1] 317545 0
13/03/2025
Ethics approval number [1] 317545 0
H-2024-0332

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 141390 0
Dr Angus Leahy
Address 141390 0
Centre for Active Living & Learning (CALL) University of Newcastle University Drive Callaghan NSW 2308
Country 141390 0
Australia
Phone 141390 0
+61 2 49216242
Fax 141390 0
Email 141390 0
[email protected]
Contact person for public queries
Name 141391 0
Angus Leahy
Address 141391 0
Centre for Active Living & Learning (CALL) University of Newcastle University Drive Callaghan NSW 2308
Country 141391 0
Australia
Phone 141391 0
+61 2 49216242
Fax 141391 0
Email 141391 0
[email protected]
Contact person for scientific queries
Name 141392 0
Angus Leahy
Address 141392 0
Centre for Active Living & Learning (CALL) University of Newcastle University Drive Callaghan NSW 2308
Country 141392 0
Australia
Phone 141392 0
+61 2 49216242
Fax 141392 0
Email 141392 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
No


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.