Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622001050741
Ethics application status
Approved
Date submitted
24/05/2022
Date registered
28/07/2022
Date last updated
25/08/2025
Date data sharing statement initially provided
28/07/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
TransformUs All Abilities – School-based physical activity and sedentary behaviour interventions for children and adolescents with disability.
Scientific title
School-based physical activity and sedentary behaviour interventions among children and adolescents with disability (TransformUs All Abilities): testing the effects on physical activity, sedentary behaviour, on-task behaviour and socio-emotional skills.
Secondary ID [1] 306317 0
None
Universal Trial Number (UTN)
U1111-1280-8828
Trial acronym
TransformUs All Abilities Effectiveness Trial
Linked study record
This is an adaption of a previously registered successful trial: Scalability of the Transform-Us! program to promote children’s physical activity and reduce prolonged sitting in Victorian primary schools (ACTRN12617000204347). This study is also linked to the TransformUs Secondary Schools Project (ACTRN12622000600741).

Health condition
Health condition(s) or problem(s) studied:
Physical activity 325249 0
Sedentary behaviour 325250 0
Condition category
Condition code
Public Health 322648 322648 0 0
Health promotion/education
Public Health 322649 322649 0 0
Other public health

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
TransformUs All Abilities is a school-based intervention targeting reducing sedentary behaviour and increasing physical activity in children and adolescents with additional needs. The objective of this trial is to test the effectiveness of TransformUs All Abilities in relation to physical activity and sedentary time, physical literacy, and cognitive functions in students with disability.

The overall duration of the intervention is 6 months – i.e., the follow-up evaluation will be at 6 months for the Effectiveness trial. The intervention will include a repertoire of activities that teachers could choose and implement differently across the day. Some examples of interventions are:
- Active breaks – short (up to 2-minutes) activities that interrupt prolonged periods (e.g., 20-30 minutes) of sitting in class. They can be incorporated into any class lesson. At least one active break should be planned for and delivered in each core lesson. For example: Active bingo, active grammar, chair yoga).
- Active lessons – longer sessions (e.g., 30 minutes) directly linked to the curriculum and involve integrating movement into the student learning experience. For example: times table teams (Maths), relay story (English).
- Active recreation – active play and recreation activities conducted before, during (including recess and lunch), and after school. The activity type, frequency and duration depend on the students' likes and on the specific characteristics of each school’s environment and timetable. These may include activity incursions (e.g., circus skills), sports (e.g., Basketball, Soccer, Netball) and other activities (e.g., Ultimate frisbee, Dodgeball, Finska).
- Changes in the school environment – active indoor/outdoor environment, active equipment, teacher encouragement (i.e., champion), active school policies. This may include, for example, a borrowing system for active equipment at lunchtime, the installation and use of standing desks in the classroom, and the use of sports uniforms for the whole week.

Teachers will be encouraged to implement the strategies as much as possible into their lessons. They will also be asked to encourage students to participate in the activities outside the classroom. The teachers and schools will have the option to participate in a teacher professional development session (online or face-to-face, lasting 30 minutes to 1 hour in duration), at a suitable time up to a month before commencing the trial. All the program resources, including a downloadable version of the teacher training, will be available through the TransformUs website (www.transformus.com.au). We will provide continuous communication and support from the TransformUs Team and a ‘champion teacher’ within the school to encourage engagement with the TransformUs resources.

Monitoring of the strategies will include Ecological Momentary Assessment (EMA) (during the intervention period). The EMAs are designed to assess the frequency and duration of intervention. These will be sent via text message and take a few minutes to complete. The EMAs will be sent up to 3 times per term for the duration of the trial. EMAs will be sent via text message.
Intervention code [1] 322854 0
Behaviour
Intervention code [2] 322855 0
Prevention
Intervention code [3] 322856 0
Lifestyle
Comparator / control treatment
N/A
Control group
Uncontrolled

Outcomes
Primary outcome [1] 331172 0
Physical activity Students will wear the ActiGraph GT9X accelerometers on their non-dominant wrist for 24 hours for eight days at each of the measurement points. Time spent on physical activity at light, moderate and vigorous intensity will be extracted. The time spent in moderate-to-vigorous intensity physical activity will be used as primary outcome.
Timepoint [1] 331172 0
Baseline - 2023-2024 T2 - 2024-2025 (6 months after baseline)
Primary outcome [2] 331390 0
Sedentary time Students will wear the ActiGraph GT9X accelerometers on their non-dominant wrist for 24 hours for eight days at each of the measurement points. Time spent sedentary will be obtained.
Timepoint [2] 331390 0
Baseline - 2023-2024 T2 - 2024-2025 (6 months after baseline)
Secondary outcome [1] 409700 0
Sleep Students will wear the ActiGraph GT9X accelerometers on their non-dominant wrist for 24 hours for eight days at each of the measurement points. Sleep duration will be obtained.
Timepoint [1] 409700 0
Baseline - 2023-2024 T2 - 2024-2025 (6 months after baseline)
Secondary outcome [2] 409702 0
Physical literacy This will be assessed using the pictorial Physical literacy in Children Questionnaire (PL-C Quest). The PL-C Quest is the only pictorial survey aligned with the Australian Physical Literacy Framework that uses images to depict each of the 30 elements. Each question contains two pictures with an orange bunny cartoon performing some activities. Children are asked to pick the picture where they think the cartoon character is being the most like them if they were in that situation. Once they pick that picture, they are asked how much the picture represents them (a bit or a lot).
Timepoint [2] 409702 0
Baseline - 2023-2024 T2 - 2024-2025 (6 months after baseline)
Secondary outcome [3] 409703 0
Implementation e.g., organisational readiness, organisational climate, decision to register, Intention to implement, current teaching practices, process evaluation measures, frequency of intervention delivery will be assessed using existing validated and reliable measures in the survey (REDCap), Ecological Momentary Assessment (via SMS, 3 times per term for the duration of the trial) and audio-recorded interviews (30 min, one on one interviews with a subsample of teachers after the intervention. A subsample of consenting teachers will be invited to participate at random. These outcomes will be assessed as a composite outcome.
Timepoint [3] 409703 0
School staff surveys: - Baseline -2023-2024 - T2 - 2024-2025 (6 months after baseline) EMAs: - 3 times per term duration of trial Interviews: - 6 months after recruitment
Secondary outcome [4] 411519 0
Focus groups with students (18-30 students in total). - Max n = 6 students per group, with varying levels of support requirements. - A small group of students will participate in a 45-min focus group session (at the end of the trial) aimed at understanding how students with disability view opportunities for physical activity throughout the school day. - Questions will relate to students' socio-emotional skills, school attachment/sense of belonging, and engagement/enjoyment . - Focus groups will take place at the school in a room/space allocated to us by the school contact person (this component will only be possible if COVID-19 related restrictions will allow research staff to visit schools). .
Timepoint [4] 411519 0
T2 - 2024-2025 (6 months after baseline)
Secondary outcome [5] 451449 0
Cognitive functions This will be measured using a forward Corsi Block-Tapping task powered by Inquisit Wed (Milliseconds Software, LLC). The task presents a sequence of boxes lighting up in yellow in a predetermined (pseudo-random) order. After the last block is lit up, the participant is required to tap on the boxes that appeared in yellow, following the order in which they were lit. The task starts with a sequence of 2 blocks (level 2) and can continue up to 9 blocks (level 9). Each level offers two chances to correctly reproduce the sequence of blocks. The test ends if a participant fails to reproduce two sequences of the same length.
Timepoint [5] 451449 0
Baseline - 2023-2024 T2 - 2024-2025 (6 months after baseline)

Eligibility
Key inclusion criteria
•Schools: Up to 6 special government or independent special schools (primary, secondary, or combined) located in Victoria catering for students with mild to moderate intellectual disability.
•School staff (leaders): 1 nominated school leader per school (n=6)
•School staff (teachers): Teachers and teacher aides delivering the program (approx. n=20)
•Students (physical activity, physical literacy and cognitive functions): Around 125 students with disability, both males and females, aged 6–18 years, attending one of the recruited schools.
•Students (focus groups): 18-30 students in total (max n=6 students per group)
Minimum age
4 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
•Mainstream schools.
•Catholic schools.
•Schools from states other than Victoria.
•School staff from schools not recruited for the trial.
•Students younger than 6 years or older than 18 years.

Study design
Purpose of the study
Prevention
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
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis
Qualitative information collected from the interviews and focus groups will be analysed using thematic analysis in NVivo 14 (released in 2023, Lumivero). Using a hybrid inductive/deductive approach, we will code data inductively and categorise codes in themes according to common implementation outcomes (i.e., acceptability, adoption, feasibility, fidelity, penetration, sustainability, and satisfaction). Where coded quotes do not apply to any of the preconcerted themes, new themes will be created.

Quantitative data will be analysed using Stata 18 (Stata Corp. LLP). Preliminary analysis will be conducted to describe the sample (demographic characteristics and distribution of the scores on the outcomes of interest). Teacher-level outcomes from survey and EMA text message responses – including current teaching practices, organisational readiness/climate, teacher’s competence/confidence, and perceived barriers and facilitators in implementation, as well as frequency and types of TransformUs All Abilities strategies implemented by teachers (i.e., EMA responses) – will be summarised descriptively. Changes over time in those outcomes’ scores will be analysed using linear mixed models. The predictor of interest will be the interaction between study group (intervention/control) and time. All models will be adjusted for common confounders (i.e., teacher’s age, sex, years of teaching experience) and controlled for the random effect of classroom as a clustering variable.

Student-level primary and secondary effectiveness outcomes will be analysed using separate linear mixed models to assess the fixed effects of the intervention (i.e., study group [intervention/control] x time [baseline/follow-up]) on each continuous outcome (i.e., physical activity, sedentary time, sleep, physical literacy, and cognitive functions), adjusting for common confounders (i.e., age, sex, and student disability/functioning) and controlling for the random effects of clustering (i.e., students in classrooms). The effects of an interaction term between study group, time and student disability/functioning will also be explored, to see whether different levels of support moderate the intervention effects.

A person-centred analysis will also be explored as secondary analysis. Person-centred analyses involve creating groups of participants with similar characteristics or similar scores on the independent variables using a variety of techniques (e.g., Cluster analysis, latent class analysis) to reduce the total variability. Compared to a variable-centred approach, this method has been suggested as a possible way of exploring how participants grouped by similar characteristics respond differently to the intervention in relation to the main outcomes of interest.

The power calculation for the main outcome of interest (physical activity) for the students participating in the Effectiveness trial is detailed below:
- The fixed effects were estimated with an a priori power calculation using G*Power software. Assuming a moderate effect size (f² = 0.15), an error probability = 0.05, power (1 – ß error probability) = 0.80, and the group variable as predictor, fixed effects were estimated to require 55 observations.
- To account for the random effects of clustering (students in the same classroom) a design effect of 1.82 was estimated (based on a coefficient of variation of 0.15 and an average number of 5 students per classroom and a conservative Intraclass Correlation Coefficient [ICC] value of 0.20), suggesting that 100 observations would be required (i.e., 55 x 1.82 = 100).
- Accounting for 25% attrition, the final total sample size needed for the effectiveness trial is 134 participants (i.e., 100 / (1 – 0.25) = 134), from 27 classrooms (134 / 5 students per class = 27).

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
29/07/2022
Actual
7/08/2023
Date of last participant enrolment
Anticipated
22/06/2023
Actual
28/06/2024
Date of last data collection
Anticipated
22/12/2023
Actual
20/12/2024
Sample size
Target
134
Accrual to date
Final
87
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 310664 0
Government body
Name [1] 310664 0
National Health and Medical Research Council (NHMRC)
Country [1] 310664 0
Australia
Primary sponsor type
University
Name
Deakin University
Address
Deakin University
Institute for Physical Activity and Nutrition
School of Exercise and Nutrition Sciences, Faculty of Health
221 Burwood Hwy Burwood VIC 3125
Country
Australia
Secondary sponsor category [1] 311879 0
Government body
Name [1] 311879 0
National Health and Medical Research Council (NHMRC)
Address [1] 311879 0
National Health and Medical Research Council (NHMRC) GPO Box 1421, Canberra ACT 2601 16 Marcus Clarke St, Canberra ACT 2601
Country [1] 311879 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 310254 0
Deakin University Human Ethics Research Committee
Ethics committee address [1] 310254 0
Ethics committee country [1] 310254 0
Australia
Date submitted for ethics approval [1] 310254 0
12/10/2021
Approval date [1] 310254 0
23/11/2021
Ethics approval number [1] 310254 0
2021-368

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

Contacts
Principal investigator
Name 117022 0
Prof Jo Salmon
Address 117022 0
Deakin University Institute for Physical Activity and Nutrition School of Exercise and Nutrition Sciences, Faculty of Health 221 Burwood Hwy Burwood VIC 3125
Country 117022 0
Australia
Phone 117022 0
+61 0392517254
Fax 117022 0
Email 117022 0
[email protected]
Contact person for public queries
Name 117023 0
Jo Salmon
Address 117023 0
Deakin University Institute for Physical Activity and Nutrition School of Exercise and Nutrition Sciences, Faculty of Health 221 Burwood Hwy Burwood VIC 3125
Country 117023 0
Australia
Phone 117023 0
+61 0392517254
Fax 117023 0
Email 117023 0
[email protected]
Contact person for scientific queries
Name 117024 0
Jo Salmon
Address 117024 0
Deakin University Institute for Physical Activity and Nutrition School of Exercise and Nutrition Sciences, Faculty of Health 221 Burwood Hwy Burwood VIC 3125
Country 117024 0
Australia
Phone 117024 0
+61 0392517254
Fax 117024 0
Email 117024 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
Yes
Will there be any conditions when requesting access to individual participant data?
Persons/groups eligible to request access:
• Researchers
Conditions for requesting access:
• Yes, conditions apply:
• Requires review on a case-by-case basis by the trial custodian, sponsor or data sharing committee
• Requires a scientifically sound proposal or protocol
• Requires approval by an ethics committee
What individual participant data might be shared?
• De-identified individual participant data:
• All outcomes data
What types of analyses could be done with individual participant data?
• Any type of analysis (i.e. no restrictions on data re-use)
When can requests for individual participant data be made (start and end dates)?
From:
After publication of main results
To:
Data will be stored for at least 15 years from the date of final publication.

Where can requests to access individual participant data be made, or data be obtained directly?
• Email of trial custodian, sponsor or committee: A de-identified version of the data could be made available upon reasonable requests submitted to Deakin University Human Research Ethics Committee ([email protected]; project reference number: 2021-368) and to [email protected].

Are there extra considerations when requesting access to 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.