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
28/07/2022
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, on-task behaviour, socio-emotional skills, school attachment/sense of belonging, and engagement/enjoyment 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 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.

Teachers will be encouraged to implement the strategies as much as possible into their lessons. They also will 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 for 30 minutes to 1 hour in duration), at a suitable time up to a month prior to 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 EMA's are designed to assess frequency and duration of intervention, these will be sent via text message and take a few minutes to complete. The EMA's will be sent up to 3 times per term for up to 6 terms in total (depending on the commencement date of the trial). EMA's 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 - 2022-2023
T2 - 2022-2023 (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 - 2022-2023
T2 - 2022-2023 (6 months after baseline)
Secondary outcome [1] 409700 0
Classroom observations on-task behaviour
Will be assessed by research staff observing students on the following behaviours: Focused on-task behaviour (e.g., reading, writing, asking/answering questions); Passive off-task (e.g., not focused, daydreaming, starring, drinking water); Off-task (e.g., not focused walking around, playing with irrelevant objects, fidgeting); Absent (e.g., went to the toilet). The different categories of off-task behaviour will be presented descriptively to provide contextual information on the type of behaviours students engaged in while off-task. A dichotomous variable (1=on-task, 0=off-task) will be used to test the intervention effects on on-task behaviour in the analysis.
Timepoint [1] 409700 0
Baseline - 2022-2023
T2 - 2022-2023 (6 months after baseline)
Secondary outcome [2] 409702 0
School attendance
Actual full-time equivalent school days attended by students will be collected as a percentage of the total number of possible student days attended over the (reporting) period. We will request Australian Curriculum, Assessment and Reporting Authority (ACARA) data to assess the attendance rates.
Timepoint [2] 409702 0
Baseline - 2022-2023
T2 - 2022-2023 (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 up to 6 terms) 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 -2022-2023
- T2 - 2022-2023 (6 months after baseline)
EMAs:
- 3 times per term for up to 6 terms
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 - 2022-2023 (6 months after baseline)

Eligibility
Key inclusion criteria
•Schools: Up to 6 special schools located in Victoria, up to 3 schools with students requiring a low to medium level of support, and up to 3 schools with students requiring a medium to high level of support. Categorising students by the level of support they receive will allow the research team to form homogenous groups by the level of support they receive rather than on diagnostic/clinical characteristics. This categorisation is intended to make the results of the trial in relation to the functioning variability easier to understand and more generalisable.
•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, on-task behaviour, and life skills): Around 125 students in total with varying levels of support requirements
•Students (focus groups): 18-30 students in total (max n=6 students per group) with varying levels of support requirements.
Minimum age
4 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
•Schools from states other than Victoria.
•Mainstream schools.

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
Quantitative data will be analysed using Stata 17 (Stata Corp. LLP). Preliminary analysis will be conducted to describe the sample (demographic characteristics and distribution of the scores on the outcomes of interest [total, by gender, by required level of support]). The assumption of normal distribution will be verified for all continuous variables and appropriate transformations will be applied to make the data normally distributed, if necessary.

The dataset will be stored in long format. Separate linear mixed models will be used to assess the fixed effects of the intervention (i.e., time [1 = baseline; 2 = end of trial]) on each continuous outcome (i.e., physical activity, social-emotional skills, engagement/enjoyment, and school attachment), adjusting for common confounders (i.e., age, sex, and student level of support) and controlling for the random effects of clustering (i.e., students in classrooms). The effects of an interaction term between time and student level of support will also be explored, to see whether different levels of support moderate the intervention effects.

On-task behaviour data (categorical) will be transformed into a dichotomous variable (i.e., 1 = on-task; 0 = off-task) by aggregating the two observable off-task behaviours (passive and disruptive) and removing observations in which a child was not in class (i.e., absent). Data will be stored in a long format to better suit the repeated measurements. Generalized linear mixed models will be used to assess the fixed effects of the intervention on the probability of observing students on-task using the variable time as explanatory (i.e., 1 = baseline; 2 = end of trial). The model will correct for the confounding effects of student’s gender, age, observed movement patterns and contextual factors (delivery mode and position in the classroom) and the random effects of clustering (i.e., multiple observation conducted with the same children who are nested in different classrooms).

Qualitative information collected from the focus groups 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.

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, and power (1 – ß error probability) = 0.80, the sample size that would been required to observe statistically significant differences using one predictor was 55 observations, using four predictors (i.e., correcting for three confounders) the required sample size would be 85 observations. Accounting for approximately 30% attrition, we will aim to recruit 125 students for this trial.

Potential confounders (i.e., age, sex, and level of support) will be adjusted in all the main analyses and will also corrected for the clustering at the class level (and the individual level for on-task behaviour).

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
29/07/2022
Actual
Date of last participant enrolment
Anticipated
22/06/2023
Actual
Date of last data collection
Anticipated
22/12/2023
Actual
Sample size
Target
145
Accrual to date
Final
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 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.