Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621000884808
Ethics application status
Approved
Date submitted
20/05/2021
Date registered
8/07/2021
Date last updated
21/07/2024
Date data sharing statement initially provided
8/07/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
A physical activity intervention for adolescents with disability: The Burn 2 Learn adapted (B2La) program
Scientific title
Evaluating the effect of the Burn 2 Learn adapted (B2La) physical activity intervention for adolescents with disability on functional capacity
Secondary ID [1] 304249 0
None
Universal Trial Number (UTN)
Trial acronym
B2La
Linked study record
This is a follow-up study to previously registered trials ACTRN12621000219886 and ACTRN12618000293268.

Health condition
Health condition(s) or problem(s) studied:
Functional capacity 321954 0
Physical inactivity 321955 0
Muscular fitness 321956 0
Mental wellbeing (Quality of life) 321958 0
Condition category
Condition code
Mental Health 319680 319680 0 0
Learning disabilities
Public Health 319681 319681 0 0
Health promotion/education
Mental Health 319682 319682 0 0
Other mental health disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Burn 2 Learn adapted (B2La) is a multi-component intervention includes the following intervention components: (i) student information seminar, (ii) school-based exercise sessions, (iii) smartphone application (app), (iv) parental support videos, and (v) provision of equipment. The intervention will take place over 9-months, however the primary end-point of the intervention is 6-months post-baseline.

Student information seminar: Delivered by teachers, the seminar will provide an overview of B2La and focus on the barriers and benefits of physical activity for individuals with disability, as well as appropriate behaviour change techniques (e.g., self-monitoring and goal setting). Teachers will be provided with a PowerPoint presentation with embedded videos designed for this project. The seminar will be approximately 60 minutes in duration, and will take place during the first week of the intervention prior to beginning the school-based exercise sessions. A teacher recording sheet will be used to monitor attendance at the student information seminar.

School-based exercise sessions: Sessions will be run during scheduled ‘Specialist Support Classes’ (students typically attend 3 x 2-hour support lessons/week). These classes cater for students with moderate-to-high learning and support needs, including students with intellectual disability, mental health issues, autism, physical disability, sensory impairment and behaviour disorders. Teachers will be asked to facilitate the delivery of at least two exercise sessions per week across two school terms (approximately 6 months). Exercise sessions will be group-administered with up to 10 participants. Participants will be able to select from 9 high-intensity interval training (HIIT) style workouts including: Gym HIIT, Class HIIT, Quick HIIT, Hip-hop HIIT, Soccer HIIT, Basketball HIIT, Netball HIIT, Athletics HIIT and Custom HIIT. Each session will include a combination of aerobic (i.e., shuttle runs, jumping jacks, running on the sport) and muscle-strengthening (i.e., body weight squat, push ups, lunges) exercises and last ~15 min in duration. Students will be encouraged to reach a target intensity of 80% of age-predicted heart rate max. As demonstrated in our feasibility study, this heart rate target is achievable for students with disability. Teachers will be provided with training and support to deliver the sessions using the ‘SAAFE’ delivery principles. Student session adherence will be monitored using the B2L app analytics, and teacher session attendance checklists. Following the primary-endpoint of the intervention (6-months post-baseline), students will be encouraged to complete sessions outside of lesson time (e.g., at home), but teachers may continue to facilitate sessions during lessons if they wish.

Smartphone app: Teachers and students will be provided with access to the B2L app (Android and iOS versions available). The app includes: (i) descriptions and depictions of exercise sessions, (ii) options for 'solo' or 'group' sessions, (iii) timer, audible prompts and display of heart rate using Bluetooth synced heart rate monitors during HIIT sessions, (iv) personalised reports outlining heart rate, and (v) teacher version allows whole-class heart rate monitoring during class sessions. Access to the B2L app will be provided to parents of students who do not own a smartphone.

Parent support videos: Parents will receive two e-newsletters (approximately weeks 1 and 9 of the intervention) containing links to videos outlining the barriers and benefits of physical activity for individuals with disability and strategies to support their children’s participation outside of school. The videos are specifically designed for the current study and will be administered to participants' parents via the preferred parental contact method provided by the study schools.

Equipment: Each school will receive an equipment pack valued at $1,400. The pack with include heart rate monitors, laminated technique and task cards, satchel, teacher handbook and cables. The laminated technique and task cards, and the teacher handbook have been designed by the research team for use in the current study.
Intervention code [1] 320583 0
Lifestyle
Intervention code [2] 320584 0
Prevention
Intervention code [3] 320585 0
Behaviour
Comparator / control treatment
Wait-list control group. Participants randomly allocated to the wait-list control group will continue with usual school practice (i.e., normal curricular lessons) for the duration of the intervention period. Schools allocated to control will then receive the intervention following final study assessments (i.e., the following year).
Control group
Active

Outcomes
Primary outcome [1] 327580 0
Functional capacity: assessed using the 6-Minute Walk Test. The 6-Minute Push Test will be used for students who self-propel a wheelchair.
Timepoint [1] 327580 0
Baseline, 6-month post-baseline assessments (primary timepoint) and 9-month post-baseline assessments.
Secondary outcome [1] 395720 0
Physical activity: Time spent (i.e., mean minutes) in moderate-to-vigorous physical activity: Assessed using wrist-worn ActiGraph GT9X Link accelerometers. Accelerometers will be worn on the non-dominant wrist for 7 consecutive days (3-day minimum wear time) for 24 hours per day (even when bathing, swimming and sleeping).
Timepoint [1] 395720 0
Baseline, 6-month post-baseline assessments and 9-month post-baseline assessments.
Secondary outcome [2] 395724 0
Lower body muscular fitness: assessed using the 30 second sit-to-stand test
Timepoint [2] 395724 0
Baseline, 6-month post-baseline assessments and 9-month post-baseline assessments.
Secondary outcome [3] 395725 0
Upper body muscular fitness: assessed using the modified push-up test (performed on knees)
Timepoint [3] 395725 0
Baseline, 6-month post-baseline assessments and 9-month post-baseline assessments.
Secondary outcome [4] 395726 0
Body composition: Height will be assessed using a portable stadiometer and weight will be assessed using a portable digital scale. Body Mass Index (BMI) will be assessed using the standard formula (Weight [kg]/Height [m]2).
Timepoint [4] 395726 0
Baseline, 6-month post-baseline assessments and 9-month post-baseline assessments.
Secondary outcome [5] 395727 0
Inhibition: assessed using the Flanker task in the cognitive portion of the National Institute of Health (NIH) Toolbox
Timepoint [5] 395727 0
Baseline, 6-month post-baseline
Secondary outcome [6] 395728 0
Working memory: assessed using the list sorting working memory tasks in the cognitive portion of the National Institute of Health (NIH) Toolbox
Timepoint [6] 395728 0
Baseline, 6-month post-baseline
Secondary outcome [7] 395729 0
Cognitive flexibility: assessed using the dimensional change card sorting test in the cognitive portion of the National Institute of Health (NIH) Toolbox
Timepoint [7] 395729 0
Baseline, 6-month post-baseline
Secondary outcome [8] 396993 0
Quality of life: assessed using the Child Health Utility 9-Dimensions, which includes 9-items (worried, sad, pain, tired, annoyed, schoolwork or work, sleep, daily routine and activities) and is scored on a 5-point scale.
Timepoint [8] 396993 0
Baseline, 6-month post-baseline assessments and 9-month post-baseline assessments.
Secondary outcome [9] 396995 0
Autonomous motivation for physical activity: assessed using identified and intrinsic subscales from the 'Behavioural Regulations in Exercise Questionnaire-2.
Timepoint [9] 396995 0
Baseline, 6-month post-baseline assessments and 9-month post-baseline assessments.
Secondary outcome [10] 396996 0
Confidence: assessed using the validated 6-item High-Intensity Interval Training Self-efficacy Questionnaire.
Timepoint [10] 396996 0
Baseline, 6-month post-baseline assessments and 9-month post-baseline assessments.
Secondary outcome [11] 397007 0
Competence: assessed using video analysis of the valid and reliable Resistance Training Skills Battery. The test requires participants to perform basic resistance training movements (e.g., push-ups) considered to be the foundation for more complex exercises used in resistance training programs.
Timepoint [11] 397007 0
Baseline, 6-month post-baseline assessments and 9-month post-baseline assessments.
Secondary outcome [12] 397008 0
On-task behavior: measured using a time momentary sampling strategy.
Timepoint [12] 397008 0
Baseline and 3-month post-baseline
Secondary outcome [13] 408507 0
Teacher reported externalising behaviour: Assessed using items of the externalising subscale of the Strengths and Difficulties Questionnaire.
Timepoint [13] 408507 0
Baseline, 6-month post-baseline assessments, and 9-month post-baseline assessments

Eligibility
Key inclusion criteria
Students (15-19 years) identifying as having a disability (any type including physical, intellectual or sensory), in the special education unit /special support classes at the consenting school. Students from both government and non-government schools will be eligible to participate. Grade 11 students will be targeted, however if additional participants are required, students in Grade 10 may also be considered.

Minimum age
15 Years
Maximum age
19 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Students that have a health or medical condition that would preclude participation in vigorous physical activity will be excluded. Students unable to follow simple verbal instructions in English (as determined by the Index of Social Competence) will be excluded.

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation to control or intervention groups will be conducted following recruitment and baseline assessments, using central randomisation by computer.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Statistical analyses: Analyses of the primary and secondary outcomes will be conducted using linear mixed models SAS V 9.1 (SAS Institute Inc, Cary, NC), with alpha levels set at p<0.05. The models will be used to assess the impact of treatment (B2La or control), time (treated as categorical with levels 6- and 9-months), the baseline value of the outcome, and the group-by-time interaction. The models will include a random participant level intercept to account for the repeated measures for each participant, and a random school intercept to account for the clustered design. The primary endpoint of the study will be 6-months from baseline, least square mean differences between the treatment groups will be presented at both follow-up time points, with 95% confidence intervals and p-values. Compared to complete case analyses, mixed models include available data for all participants in the analysis and are thus both more efficient and robust to bias. Mixed model analyses are consistent with the intention-to-treat principle, assuming the data are missing at random. The validity of this assumption will be explored by assessing relationships between missingness and observed values of covariates and previous outcomes. Multiple imputation and/or pattern mixture modelling will be considered as sensitivity analyses if the dropout rate is substantial. Four potential moderators (i.e., socio-economic status, sex, initial weight status and disability type) will be explored using interaction terms.

Power calculation: Although adolescent data are lacking, studies conducted in adult populations with chronic health conditions have reported minimal clinically important differences (MCID) of 24 to 44 metres using the 6MWT. In our pilot study, we observed a large increase in distance covered from baseline to post-test (163m). However, our pilot study did not include a control group and effects are typically smaller in effectiveness trials. Based on the information above, we estimate that a treatment effect of 80m will represent a MCID in our population. Through simulations (n=10,000) and using data from our pilot study (i.e., baseline post-test correlation of r = 0.60, standard deviation of 90m and intraclass correlation of 0.2), we have determined that our study will require a sample of 30 schools with an average 7 participants per school. This sample size will be enough to detect a MCID of 80m with 90% power at a 5% significance level. Allowing for 30% loss to follow-up at 6-months we will recruit 10 students from 30 schools (total sample size of 300).

Economic evaluation: the efficiency and affordability of the intervention will be assessed using cost-effectiveness analysis and budget impact respectively, conducted from a public finance perspective. The effectiveness measure will be based on the primary outcome (6MWT). The resource use and costs for the intervention and usual practice will be prospectively measured and derived from project records (staff and consumables), teacher surveys and school records. Additional costs in the intervention group are anticipated to be labour (implementation support), program development and training costs. The cost effectiveness analysis will be conducted on a ‘within trial’ basis, that is, over the 6-month study period, comparing incremental costs and benefits. Affordability of the program will be calculated using budget impact analysis, over a standard accounting cycle and is designed to assist decision making and hence assist the translation of cost-effective and affordable programs. Scenario analysis will assess the costs to implement the program at scale across NSW.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
6/05/2022
Actual
6/05/2022
Date of last participant enrolment
Anticipated
31/03/2023
Actual
6/04/2023
Date of last data collection
Anticipated
12/04/2024
Actual
5/12/2023
Sample size
Target
300
Accrual to date
Final
255
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 308623 0
Government body
Name [1] 308623 0
National Health and Medical Research Council
Country [1] 308623 0
Australia
Primary sponsor type
Individual
Name
Prof David Lubans
Address
The University of Newcastle
Level 3, ATC building
University Drive
Callaghan, NSW, 2308
Country
Australia
Secondary sponsor category [1] 309492 0
None
Name [1] 309492 0
Address [1] 309492 0
Country [1] 309492 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 308555 0
University of Newcastle Human Research Ethics Committee
Ethics committee address [1] 308555 0
Ethics committee country [1] 308555 0
Australia
Date submitted for ethics approval [1] 308555 0
28/06/2021
Approval date [1] 308555 0
30/09/2021
Ethics approval number [1] 308555 0
H-2021-0262
Ethics committee name [2] 310215 0
New South Wales Department of Education
Ethics committee address [2] 310215 0
Ethics committee country [2] 310215 0
Australia
Date submitted for ethics approval [2] 310215 0
29/06/2021
Approval date [2] 310215 0
18/11/2021
Ethics approval number [2] 310215 0
SERAP 2021257

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

Contacts
Principal investigator
Name 111122 0
Prof David Lubans
Address 111122 0
The University of Newcastle
Level 3, ATC Building
University Drive
Callaghan, NSW, 2308
Country 111122 0
Australia
Phone 111122 0
+61 02 49212049
Fax 111122 0
Email 111122 0
[email protected]
Contact person for public queries
Name 111123 0
David Lubans
Address 111123 0
The University of Newcastle
Level 3, ATC Building
University Drive
Callaghan, NSW, 2308
Country 111123 0
Australia
Phone 111123 0
+61 02 49212049
Fax 111123 0
Email 111123 0
[email protected]
Contact person for scientific queries
Name 111124 0
David Lubans
Address 111124 0
The University of Newcastle
Level 3, ATC Building
University Drive
Callaghan, NSW, 2308
Country 111124 0
Australia
Phone 111124 0
+61 02 49212049
Fax 111124 0
Email 111124 0
[email protected]

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
EmbaseTime-efficient physical activity intervention for older adolescents with disability: rationale and study protocol for the Burn 2 Learn adapted (B2La) cluster randomised controlled trial.2022https://dx.doi.org/10.1136/bmjopen-2022-065321
N.B. These documents automatically identified may not have been verified by the study sponsor.