Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622000600741
Ethics application status
Approved
Date submitted
10/03/2022
Date registered
21/04/2022
Date last updated
17/04/2024
Date data sharing statement initially provided
21/04/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
Testing the effectiveness and implementation at scale of TransformUs program on physical activity and sitting time in Australian Secondary Schools.
Scientific title
Testing the effectiveness on physical activity, health outcomes and behavioural outcomes, and implementation at scale of TransformUs program on physical activity and sitting time in secondary school students.
Secondary ID [1] 305586 0
None
Universal Trial Number (UTN)
Trial acronym
TransformUs Secondary
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) for the Australian secondary school setting.

Health condition
Health condition(s) or problem(s) studied:
Sedentary behaviour in adolescents 324027 0
Physical activity in adolescents 324028 0
Condition category
Condition code
Public Health 321532 321532 0 0
Health promotion/education

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
TransformUs is a school-based intervention targeting reducing sedentary behaviour and increasing physical activity that will be rolled out across Australian secondary schools.
Overall duration of the intervention is 6 months i.e., the follow-up evaluation will be at 6 months for both the Effectiveness Trial and Implementation Trial. The effectiveness and implementation trials will run parallel to one another. Schools can only be involved in one trial, not both. Frequency and duration of each strategy will vary between the schools, teachers and students. Each of these components will include a repertoire of activities that teachers could choose and implement differently across the day. However, we are expecting that:
- Active breaks are 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 are 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, before school, during school [recess and lunch included], after school) will depend on the length of each school breaks. Organised or non-organised activities frequency and length will also depend on the students likes, for example: Organised lunchtime Sports/activities could include Activity incursion: circus skills; Cross year level: Sports/activities (e.g. Basketball, Soccer, Netball); Year level activity: Activity (e.g. Ultimate frisbee, Dodge ball, Finska).
- Changes in the school environment (i.e., active indoor/outdoor environment, active equipment, teacher encouragement [champion], active school policies). For example: Borrowing system for active equipment at lunchtime; standing desks; 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 teacher will participate in a teacher development session (online or face to face, lasting for 30 minutes to 1 hour in duration). All the program resources, including a downloadable version of the teacher training, will be available through the TransformUs website. 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.
For both the Effectiveness and Implementation Trials, the monitoring of the strategies will be including Ecological Momentary Assessment (during the intervention period) and the teacher survey. Both trials will also utilise interviews (at the end of the intervention – i.e., after 6 months).
Intervention code [1] 321996 0
Behaviour
Intervention code [2] 321997 0
Prevention
Intervention code [3] 321998 0
Lifestyle
Comparator / control treatment
It is not feasible to have a true control group from another state/territory as the program will be accessible nationwide on our website, and therefore we will use a waitlist control. The recruitment of the effectiveness trial schools will be staggered, i.e., as every 2 schools are recruited, they will be randomly assigned (using a computer-generated randomisation tool) to either receive the intervention (physical activity strategies) or to be put on a 6-month waitlist. The waitlisted schools will act as the comparator. Waitlisted schools will receive full access to the intervention and program after the final data collection has occurred (6 months after registration).
Control group
Active

Outcomes
Primary outcome [1] 330331 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.
Timepoint [1] 330331 0
Baseline - 2023-2024
T2 - 2023-2024 (6 months after baseline)
Primary outcome [2] 330332 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 in sedentary time will be obtained.
Timepoint [2] 330332 0
Baseline - 2023-2024
T2 - 2023-2024 (6 months after baseline)
Primary outcome [3] 330333 0
Waist circumference
Will be assessed using a flexible steel tape at the umbilicus by trained staff. Two measurements will be taken, where a discrepancy of >0.5 cm is apparent, a third measurement was taken and the average of each was used.
Timepoint [3] 330333 0
Baseline - 2023-2024
T2 - 2023-2024 (6 months after baseline)
Secondary outcome [1] 406454 0
PRIMARY OUTCOME
Body mass Index (BMI)
Adolescents’ stature will be measured to the nearest 0.1 cm using portable stadiometers, and body mass will be measured to the nearest 0.05 kg using portable calibrated electronic scales. BMI (kg/m2) will be calculated based on stature and body mass
Timepoint [1] 406454 0
Baseline - 2023-2024
T2 - 2023-2024 (6 months after baseline)
Secondary outcome [2] 406757 0
Blood pressure (BP)
Will be measure using a blood pressure monitor (e.g., Mobil-O-Graph 24h PWA). Systolic and diastolic BP measurements will be taken three times on the participant’s right arm. The first measure will be performed after five minutes of seated rest with the remaining two measurements taken at 1-min intervals. The three BP measurements will be averaged for a final value.

*This will be an elective add on for students. A tiered consent process will be used to determine this subsample.
Timepoint [2] 406757 0
Baseline - 2023-2024
T2 - 2023-2024 (6 months after baseline)
Secondary outcome [3] 407320 0
Glucose
Markers of cardiometabolic heath will be assessed utilising a dry blood spot analysis technique (finger prick blood spot test).

*This will be an elective add on for students. A tiered consent process will be used to determine this subsample.
Timepoint [3] 407320 0
Baseline - 2023-2024
T2 - 2023-2024 (6 months after baseline)
Secondary outcome [4] 407993 0
Insulin
Markers of cardiometabolic heath will be assessed utilising a dry blood spot analysis technique (finger prick blood spot test).

*This will be an elective add on for students. A tiered consent process will be used to determine this subsample.
Timepoint [4] 407993 0
Baseline - 2023-2024
T2 - 2023-2024 (6 months after baseline)
Secondary outcome [5] 407994 0
Triglycerides
Markers of cardiometabolic heath will be assessed utilising a dry blood spot analysis technique (finger prick blood spot test).

*This will be an elective add on for students. A tiered consent process will be used to determine this subsample.
Timepoint [5] 407994 0
Baseline - 2023-2024
T2 - 2023-2024 (6 months after baseline)
Secondary outcome [6] 407995 0
HDL-cholesterol
Markers of cardiometabolic heath will be assessed utilising a dry blood spot analysis technique (finger prick blood spot test).

*This will be an elective add on for students. A tiered consent process will be used to determine this subsample.
Timepoint [6] 407995 0
Baseline - 2023-2024
T2 - 2023-2024 (6 months after baseline)
Secondary outcome [7] 407996 0
LDL-cholesterol
Markers of cardiometabolic heath will be assessed utilising a dry blood spot analysis technique (finger prick blood spot test).

*This will be an elective add on for students. A tiered consent process will be used to determine this subsample.
Timepoint [7] 407996 0
Baseline - 2023-2024
T2 - 2023-2024 (6 months after baseline)
Secondary outcome [8] 407997 0
25-hydroxyvitamin D
Markers of cardiometabolic heath will be assessed utilising a dry blood spot analysis technique (finger prick blood spot test).

*This will be an elective add on for students. A tiered consent process will be used to determine this subsample.
Timepoint [8] 407997 0
Baseline - 2023-2024
T2 - 2023-2024 (6 months after baseline)
Secondary outcome [9] 407998 0
Class engagement
Will be assessed using validated questions that will be included on the survey via REDCap.
Timepoint [9] 407998 0
Baseline - 2023-2024
T2 - 2023-2024 (6 months after baseline)
Secondary outcome [10] 407999 0
Self-reported physical activity
Will be assessed using validated questions that will be included on the survey via REDCap.
Timepoint [10] 407999 0
Baseline - 2023-2024
T2 - 2023-2024 (6 months after baseline)
Secondary outcome [11] 408443 0
Classroom observations on-task behaviour
Will be assessed by research staff observing students on the following behaviours: Focused on-task (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). This data will be collected via REDCap. These outcomes will be assessed as a composite outcome.
Timepoint [11] 408443 0
Baseline - 2023-2024
T2 - 2023-2024 (6 months after baseline)
Secondary outcome [12] 408444 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 [12] 408444 0
School staff surveys: - Baseline - 2023-2024 - T2 - 2023-2024 (6 months after baseline)
EMAs: - 3 times per term for up to 6 terms Interviews: - 6 months after recruitment
Secondary outcome [13] 408446 0
Environmental changes
The newly developed School Physical Activity Environments (SPACES) Audit Tool will be used to evaluate the outdoor grounds and the immediate surrounding area of each school.
Timepoint [13] 408446 0
Baseline - 2023-2024
T2 - 2023-2024 (6 months after baseline)
Secondary outcome [14] 408447 0
Adolescents’ activity levels in different areas
Will be assessed using SOPLAY (System for Observing Play and Leisure Activity in Youth) to observe and record adolescents’ activity levels in different areas of the school grounds during recess and lunchtime. SOPLAY uses momentary time sampling techniques to record the activity level (i.e., sedentary, walking, very active) of each individual within a pre-determined target area.
Timepoint [14] 408447 0
Baseline - 2023-2024
T2 - 2023-2024 (6 months after baseline)
Secondary outcome [15] 408448 0
Musculoskeletal health
To assess the location of any musculoskeletal discomfort, the modified Nordic Musculoskeletal Questionnaire will be used. Participants will be asked to report (in the student survey) if, during classroom lessons over the last seven days, they had experienced any muscle, joint or bone discomfort.
Timepoint [15] 408448 0
Baseline - 2023-2024
T2 - 2023-2024 (6 months after baseline)
Secondary outcome [16] 408449 0
Pubertal status
Will be assessed using Tanner staging (Sexual Maturity Rating) to assess secondary sex characteristics during puberty. This will be included in the student survey.
Timepoint [16] 408449 0
Baseline - 2023-2024
T2 - 2023-2024 (6 months after baseline)

Eligibility
Key inclusion criteria
IMPLEMENTATION TRIAL
•As this is a real-world trial, all Australian secondary schools and school staff are eligible to register.
•TransformUs will be available to all secondary school staff in Australia, however, the research component will only be offered to secondary staff at Government and Independent schools (*). In 2020 there were 113,084 secondary school staff at Government and Independent schools across the country (ABS, 2020). Based on uptake of the TransformUs Primary program (ACTRN12617000204347), it is likely that no more than 5% of eligible staff will participate, which equates to approx. n=5654 staff. Only teachers registered to TransformUs who work in Government/Independent schools will be invited to take part in the research (surveys, EMAs and interviews). Based on response rates from TransformUs Primary, this is likely to be no more than 40% of registrants.

*Note: ethical approval will be sought from each State/Territory’s equivalent of the Victorian Department of Education and Training for the research component.

EFFECTIVENESS TRIAL
•Schools: Victorian and Tasmanian Government and Independent secondary schools (urban or rural), as well as Catholic secondary schools in the Archdiocese of Melbourne or Archdiocese of Hobart (as these are the two largest dioceses in each state). We aim to recruit a diverse range of schools from urban and regional areas, SES, type (Government, Independent, Catholic) and size. (n=Up to 10 schools).
•School staff (leaders): 1 nominated school leader per school (n=10)
•Year 7-10 teaching school staff at the Effectiveness trial schools will be invited to test the effectiveness of the program. *may be targeted depending on which teachers are delivering the intervention e.g. if maths is selected maths teachers (n=80)
•All year 7-10 students from Effectiveness trial schools will be invited to participate in the evaluation of the intervention (n=600)
Minimum age
11 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
IMPLEMENTATION TRIAL
•Any registrant working at a Catholic school will not be invited to take part in the research component (surveys, EMA’s 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.
EFFECTIVENESS TRIAL
•Teachers who only teach years 11 or 12 and students in year 11 and 12 will not be recruited into the Effectiveness Trial. This is due to the timing of follow-up assessments coinciding with when end-of-year exams are likely to take place.

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)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software (i.e. computerised sequence generation).
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other
Other design features
Stepped wedge with a wait list control.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Descriptive statistics will be used to describe the sample and percentage of participants who provided valid data for each time point. Linear mixed models will be used ((where the unit of the analysis (students) will be nested within cluster (class)) to examine the intervention effects of different level of implementation on key outcomes variables among adolescents. Separate models will be evaluated for each assessment point (i.e. at 6 months for the effectiveness trial and the implementation trial); adjusting for baseline levels of the outcome.

The level of implementation will be assessed using an implementation index. Data on aspects of implementation of each intervention component (i.e. active classroom, active recreation and school environment) will be scored, summed and collapsed into tertiles (low, middle and high implementation), using the implementation information that will be gathered from surveys and schools’ audit.

For the Environmental changes (SPACES data) an ICC and percent agreement will be calculated to assess reliability between virtual and physical audit tools. For the Adolescents’ activity levels in different areas (SOPLAY data): Data will be aggregated across scans. Differences in activity levels will be analyses using multilevel analyses to examine intervention effects.

All models will be adjusted for measured confounders age, gender, baseline values and accounted for clustering by school.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
19/06/2023
Actual
7/08/2023
Date of last participant enrolment
Anticipated
28/06/2024
Actual
Date of last data collection
Anticipated
20/12/2024
Actual
Sample size
Target
6344
Accrual to date
282
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 309950 0
Government body
Name [1] 309950 0
NHMRC
Country [1] 309950 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] 310991 0
Government body
Name [1] 310991 0
National Health and Medical Research Council
Address [1] 310991 0
NHMRC
GPO Box 1421, Canberra ACT 2601
16 Marcus Clarke St, Canberra ACT 2601
Country [1] 310991 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 309665 0
Deakin University Human Ethics Research Committee
Ethics committee address [1] 309665 0
Ethics committee country [1] 309665 0
Australia
Date submitted for ethics approval [1] 309665 0
27/07/2021
Approval date [1] 309665 0
20/09/2021
Ethics approval number [1] 309665 0
2021-269

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

Contacts
Principal investigator
Name 114962 0
Prof Jo Salmon
Address 114962 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 114962 0
Australia
Phone 114962 0
+61 03 92517254
Fax 114962 0
Email 114962 0
[email protected]
Contact person for public queries
Name 114963 0
Jo Salmon
Address 114963 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 114963 0
Australia
Phone 114963 0
+61 03 9244 3033
Fax 114963 0
Email 114963 0
[email protected]
Contact person for scientific queries
Name 114964 0
Jo Salmon
Address 114964 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 114964 0
Australia
Phone 114964 0
+61 03 9251 7254
Fax 114964 0
Email 114964 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.