Trial Review

Registering a new trial?

To achieve prospective registration, we recommend submitting your trial for registration at the same time as ethics submission.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12621000219886
Ethics application status
Approved
Date submitted
29/01/2021
Date registered
3/03/2021
Date last updated
3/03/2021
Date data sharing statement initially provided
3/03/2021
Type of registration
Retrospectively registered

Titles & IDs
Public title
A scalable school-based physical activity intervention for adolescents with disability: The Burn 2 Learn adapted (B2La) pilot feasibility trial
Scientific title
Assessing the feasibility of a scalable school-based physical activity intervention for adolescents with disability : The Burn 2 learn adapted (B2La) pilot feasibility trial
Secondary ID [1] 303290 0
Nil known
Universal Trial Number (UTN)
Trial acronym
B2La
Linked study record
This is a follow-up study to a previously registered trial ACTRN12618000293268.

Health condition
Health condition(s) or problem(s) studied:
Physical disability 320497 0
Intellectual disability 320498 0
Mental wellbeing 320499 0
Muscular fitness 320500 0
Condition category
Condition code
Mental Health 318367 318367 0 0
Learning disabilities
Mental Health 318715 318715 0 0
Other mental health disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The Burn 2 Learn adapted intervention involved the following intervention components

1) Professional development workshop: 1 half day workshop (approx. 4 hours) was conducted for two special education teachers identified and recruited to deliver the Burn 2 Learn adapted intervention. The workshop involved a combination of didactic delivery, interactive discussion, short videos, and practical demonstrations/activities (e.g., designing and completing a B2L adapted HIIT session). The workshop provided a rationale for the intervention with a specific focus on the impact of vigorous physical activity for students’ health, as well as the roles and responsibilities of teachers. During the workshop, adaptations to a previous version of the Burn 2 Learn intervention were discussed (and subsequently implemented) to suit the needs and ability of students with disability.

2) School-based physical activity sessions: Following the workshop, teachers were responsible for delivering 2-3 weekly high-intensity interval training (HIIT) sessions to students in the special education unit at their school, for a period of 2 months. Session adherence was monitored via objective data gathered through the purpose-built smartphone app. HIIT sessions were conducted during class-time, led by classroom teachers, and assisted by learning and support teachers. HIIT sessions were typically 8 minutes in length and consisted of body-weight (e.g., push-up) and aerobic (e.g., 10 m shuttle run) exercises. Students were encouraged to work at an intensity equivalent to =85% of their age-predicted maximum heart rate. Heart rate data were displayed on an iPad during HIIT sessions. Several adaptations to HIIT sessions (which were discussed in the professional development workshop) were implemented throughout the intervention period. Firstly, a high instructor-to-participant ratio (approx. 1 teacher to 4 students) was considered necessary to engage students in physical activity sessions. Secondly, rather than completing one block of HIIT for 8 minutes, teachers would facilitate 2x 4 minute HIIT blocks, with a small rest in between. Finally, teachers would simplify the exercises performed during HIIT to suit the fitness and ability level of students.

3) Program resources: To increase engagement in the intervention, students were equipped with Bluetooth heart rate monitors during school-based physical activity sessions, which were paired with a bespoke iPad application (Burn 2 Learn) to display live heart rate data. Teachers were also provided with a suite of pre-designed HIIT task and technique cards to aid intervention delivery.
Intervention code [1] 319592 0
Lifestyle
Intervention code [2] 319593 0
Prevention
Intervention code [3] 319594 0
Behaviour
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 326341 0
Acceptability domain of feasibility as assessed by study-specific post-program questionnaire
Timepoint [1] 326341 0
Intervention endpoint (2-months post-baseline)
Primary outcome [2] 326654 0
Implementation domain of feasibility as assessed by researcher fidelity observations using a study-specific criteria checklist, and heart rate data gathered from the B2L iPad application
Timepoint [2] 326654 0
Fidelity observations conducted in weeks 2 and 6 of the intervention
Heart rate data (averaged across all sessions conducted over the 2-month intervention period)
Primary outcome [3] 326655 0
Adaptation domain of feasibility as assessed by study-specific post-program questionnaire, and researcher fidelity observations
Timepoint [3] 326655 0
Post-program questionnaire assessed at intervention endpoint (2-months post-baseline)
Fidelity observations conducted in weeks 2 and 6 of the intervention
Secondary outcome [1] 391101 0
Practicality domain of feasibility (primary outcome) as assessed by study-specific post-program questionnaire
Timepoint [1] 391101 0
Intervention endpoint (2-months post-baseline)
Secondary outcome [2] 391102 0
Preliminary efficacy defined as functional capacity as assessed via 6 minute walk/run test
Timepoint [2] 391102 0
Baseline and post-intervention (2-months post-baseline)
Secondary outcome [3] 392291 0
Preliminary efficacy defined as lower body muscular fitness and assessed via 30s sit-to-stand test
Timepoint [3] 392291 0
Intervention endpoint (2-months post-baseline)
Secondary outcome [4] 392292 0
Preliminary efficacy defined as upper-body muscular fitness and assessed via a modified push-up test
Timepoint [4] 392292 0
Baseline and post-intervention (2-months post-baseline)
Secondary outcome [5] 392293 0
Mood state: A one-item study-specific mood state questionnaire was administered before and following physical activity sessions
Timepoint [5] 392293 0
Pre and post physical activity sessions for weeks 1, 2, 3, 4, and 5 of the intervention

Eligibility
Key inclusion criteria
Grade 11 and 12 students in the special education unit /special support classes at the consenting school.
Minimum age
15 Years
Maximum age
19 Years
Sex
Both males and females
Can healthy volunteers participate?
No
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
Statistical methods / analysis
As this was a pilot feasibility trial a power calculation was not conducted. We attempted to recruit 2 specialist support classes (approx. 20 students).

Data for acceptability, adaptation, implementation, and practicality were analyzed using descriptive statistics (i.e., mean, standard deviation, percentages), or qualitatively described where appropriate. Outcomes for preliminary efficacy were analyzed using paired sample t-tests to determine change in mean from baseline to post-test. Analyses were conducted in IBM SPSS Statistics for Windows (Version 26; 2010 SPSS Inc, IBM Company, Armonk, NY). As this was an unpowered trial Cohen’s d was 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
Completed
Date of first participant enrolment
Anticipated
Actual
19/06/2020
Date of last participant enrolment
Anticipated
Actual
19/06/2020
Date of last data collection
Anticipated
Actual
31/08/2020
Sample size
Target
20
Accrual to date
Final
16
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 307707 0
Government body
Name [1] 307707 0
National Health and Medical Research Council
Country [1] 307707 0
Australia
Funding source category [2] 307974 0
Government body
Name [2] 307974 0
New South Wales Department of Education
Country [2] 307974 0
Australia
Primary sponsor type
Individual
Name
David R. Lubans
Address
University of Newcastle, Priority Research Centre for Physical Activity and Nutrition, Level 3, ATC building, University Drive, Callaghan, NSW, 2308
Country
Australia
Secondary sponsor category [1] 308403 0
None
Name [1] 308403 0
Address [1] 308403 0
Country [1] 308403 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 307735 0
Human Research Ethics Committee of the University of Newcastle
Ethics committee address [1] 307735 0
Ethics committee country [1] 307735 0
Australia
Date submitted for ethics approval [1] 307735 0
14/05/2020
Approval date [1] 307735 0
17/06/2020
Ethics approval number [1] 307735 0
H-2016-0424
Ethics committee name [2] 307740 0
State Education Research Education Process (SERAP)
Ethics committee address [2] 307740 0
Ethics committee country [2] 307740 0
Australia
Date submitted for ethics approval [2] 307740 0
01/03/2017
Approval date [2] 307740 0
28/04/2017
Ethics approval number [2] 307740 0
SERAP2017116

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

Contacts
Principal investigator
Name 108326 0
Prof David Lubans
Address 108326 0
The University of Newcastle
Level 3, ATC Building
University Drive
Callaghan, NSW, 2308
Country 108326 0
Australia
Phone 108326 0
+61 249212049
Fax 108326 0
Email 108326 0
david.lubans@newcastle.edu.au
Contact person for public queries
Name 108327 0
David Lubans
Address 108327 0
The University of Newcastle
Level 3, ATC Building
University Drive
Callaghan, NSW, 2308
Country 108327 0
Australia
Phone 108327 0
+61 249212049
Fax 108327 0
Email 108327 0
david.lubans@newcastle.edu.au
Contact person for scientific queries
Name 108328 0
David Lubans
Address 108328 0
The University of Newcastle
Level 3, ATC Building
University Drive
Callaghan, NSW, 2308
Country 108328 0
Australia
Phone 108328 0
+61 249212049
Fax 108328 0
Email 108328 0
david.lubans@newcastle.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


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
SourceTitleYear of PublicationDOI
EmbaseFeasibility of a school-based physical activity intervention for adolescents with disability.2021https://dx.doi.org/10.1186/s40814-021-00857-5
N.B. These documents automatically identified may not have been verified by the study sponsor.