Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622001082796
Ethics application status
Approved
Date submitted
3/08/2022
Date registered
4/08/2022
Date last updated
4/08/2022
Date data sharing statement initially provided
4/08/2022
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 (implementation trial).
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 (implementation trial).
Secondary ID [1] 307370 0
None
Universal Trial Number (UTN)
U1111-1281-1103
Trial acronym
TransformUs All Abilities Implementation 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 directly linked to the TransformUs All Abilities Project Effectiveness Trial (ACTRN12622001050741), as we are conducting a hybrid implementation-effectiveness trial. This study is also linked to the TransformUs Secondary Schools Project (ACTRN12622000600741).

Health condition
Health condition(s) or problem(s) studied:
Physical activity
 326680 0
Sedentary behaviour 326681 0
Condition category
Condition code
Public Health 323920 323920 0 0
Health promotion/education
Public Health 323921 323921 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 implementation of the TransformUs All Abilities program in the real-world school environment.
The overall duration of the intervention is 6 months (i.e., the follow-up evaluation will be at 6 months from the initial registration). 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 incursion (e.g., circus skills), sports (e.g., Basketball, Soccer, Netball) and other activities (e.g., Ultimate frisbee, Dodge ball, 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 sport uniform during whole week.
Additionally, teachers will have access to professional development resources on the website, including example lesson plans and teacher training to assist with the implementation of the above-mentioned strategies/interventions.
To monitor the level of adherence to the strategies/interventions, teachers involved in the TransformUs All Abilities research component will be asked to complete an online survey at baseline and six months, Ecological Momentary Assessment (EMAs) via text message, and a subsample will be asked to participate in an interview after 6 months. These measures are discussed in further detail in Step 4: Outcomes.
Intervention code [1] 323797 0
Lifestyle
Intervention code [2] 323798 0
Behaviour
Intervention code [3] 323799 0
Prevention
Comparator / control treatment
None
Control group
Uncontrolled

Outcomes
Primary outcome [1] 331729 0
Implementation-level outcomes (i.e., organisational readiness, organisational climate, decision to register, intention to implement, current teaching practices). This will be assessed via surveys with school staff that will be conducted online using REDCap. This a composite outcome.
Timepoint [1] 331729 0
- Baseline -2022-2023
- T2 - 2022-2023 (6 months after baseline)
Primary outcome [2] 332202 0
Process evaluation (frequency and type of activities implemented by teachers). This will be assessed via Ecological Momentary Assessments (EMAs) that will be conducted via text message.
Timepoint [2] 332202 0
3 times per term for up to 6 terms
Secondary outcome [1] 412524 0
Implementation-level outcomes (i.e., reach, perceived effectiveness, adoption, implementation, maintenance). This will be assessed via one-on-one semi-structured interviews that will be conducted over the phone or videoconference. Interviews will be conducted by a member of the research team and will be audio-recorded.
Timepoint [1] 412524 0
6 months after recruitment

Eligibility
Key inclusion criteria
• As this is a real-world trial, all Australian schools and school staff are eligible to register.
• School staff working at government or independent schools in Victoria, Queensland and Tasmania (*) who register for the program will be invited to take part in the implementation research component.
*Note: approval to conduct research in the educational setting will be sought from the Victorian Department of Education and Training, the Tasmanian Department of Education and the Queensland Department of Education prior to the start of recruitment.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
• Registrants from states/territories other than Victoria, Queensland, South Australia or Tasmania will not be invited to take part in the research. This is an operational decision as it would require applications to each state/territories’ equivalent education department ethics committee.
• Any registrant working at a Catholic school will not be invited to take part in the research component (surveys or interviews). This is an operational decision as it would require applications to conduct research in these schools to approx. 25 separate dioceses across the country.

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
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis
Quantitative data collected through surveys and EMAs will be analysed using Stata 17 (Stata Corp. LLP). Preliminary analysis will be conducted to describe the sample and the outcomes of interest by demographic characteristics (e.g., age, gender, years of teaching experience). Changes over time in the survey scores and the EMA responses will be analysed using linear mixed models.
Qualitative information collected through interviews will be transcribed verbatim and analysed using NVivo software; each quote will be coded and categorised in themes according to common implementation outcomes. Where coded quotes do not apply to any of the preconcerted themes, new themes will be created.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
26/09/2022
Actual
Date of last participant enrolment
Anticipated
22/06/2023
Actual
Date of last data collection
Anticipated
22/12/2023
Actual
Sample size
Target
172
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD,SA,TAS,VIC

Funding & Sponsors
Funding source category [1] 311653 0
Government body
Name [1] 311653 0
National Health and Medical Research Council (NHMRC)
Country [1] 311653 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] 313098 0
Government body
Name [1] 313098 0
National Health and Medical Research Council (NHMRC)
Address [1] 313098 0
National Health and Medical Research Council (NHMRC)
GPO Box 1421, Canberra ACT 2601
16 Marcus Clarke St, Canberra ACT 2601
Country [1] 313098 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 311108 0
Deakin University Human Ethics Research Committee
Ethics committee address [1] 311108 0
Human Research Ethics Office
Deakin University
221 Burwood Hwy
Burwood, VIC 3125
Ethics committee country [1] 311108 0
Australia
Date submitted for ethics approval [1] 311108 0
07/12/2021
Approval date [1] 311108 0
16/12/2021
Ethics approval number [1] 311108 0
2021-368

Summary
Brief summary
TransformUs All Abilities is a hybrid effectiveness-implementation trial and the outcomes of both trials will contribute to evaluating the roll-out of TransformUs All Abilities. This registration describes the the Implementation component of our hybrid trial. The Effectiveness Trial is registered separately (ACTRN12622001050741).

TransformUs All Abilities is a behavioural school-based intervention targeting reducing sedentary behaviour and increasing physical activity in students with additional needs. 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).

The adapted TransformUs components and supporting resources will be made available in an “All Abilities” section on our website and adaptations to existing activities will be embedded in other sections as well (i.e., Primary, Secondary, Higher Education). Teachers who agree to take part in the Implementation trial will be able to access all the training material via the TransformUs website and will also provide data either online, via text or over the phone interviews. As the program will be available to all Australian primary and secondary schools (mainstream or specialist), an online delivery mode has been deemed the most feasible and sustainable.

The focus of this trial will be on investigating the implementation-level outcomes (e.g., acceptability, adoption, feasibility, fidelity, penetration, sustainability, satisfaction) of the TransformUs All Abilities, to understand whether the program is feasible, practical, and sustainable in a real-world environment. School staff involved in the implementation trial will be asked to complete an online survey on two occasions, ecological momentary assessments 3 times per term for up to 6 terms, and a sub-sample will be invited to participate in an interview.

In this study, the total number of potential combined primary/secondary schools is 3,440. Based on the uptake of the TransformUs Primary program, we anticipate that approximately 5% of eligible schools and staff may register for the program (i.e., 172 schools).
Trial website
https://transformus.com.au/
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 119970 0
Prof Jo Salmon
Address 119970 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 119970 0
Australia
Phone 119970 0
+61 03 92517254
Fax 119970 0
Email 119970 0
jo.salmon@deakin.edu.au
Contact person for public queries
Name 119971 0
Prof Jo Salmon
Address 119971 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 119971 0
Australia
Phone 119971 0
+61 03 92517254
Fax 119971 0
Email 119971 0
transformus@deakin.edu.au
Contact person for scientific queries
Name 119972 0
Prof Jo Salmon
Address 119972 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 119972 0
Australia
Phone 119972 0
+61 03 92517254
Fax 119972 0
Email 119972 0
jo.salmon@deakin.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
Once data is available we will reassess availability of de-identified data.


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.