Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12617000204347
Ethics application status
Approved
Date submitted
25/01/2017
Date registered
8/02/2017
Date last updated
19/10/2023
Date data sharing statement initially provided
8/01/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Scalability of the TransformUs program to promote children’s physical activity and reduce prolonged sitting in Victorian primary schools.
Scientific title
Scalability of the TransformUs program to promote children’s physical activity and reduce prolonged sitting in Victorian primary schools.
Secondary ID [1] 290383 0
None
Universal Trial Number (UTN)
Trial acronym
TransformUs
Linked study record
ACTRN12609000715279

Health condition
Health condition(s) or problem(s) studied:
Sedentary behaviour in children 300701 0
Physical Activity in children 301708 0
Condition category
Condition code
Public Health 301408 301408 0 0
Health promotion/education
Public Health 301409 301409 0 0
Epidemiology

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
A behavioural intervention targeting reducing sedentary behaviour and increasing physical activity will be rolled out across Victorian primary schools. This is a scale up of a previously registered successful trial: Transform-Us! an intervention promoting children’s health (ACTRN12609000715279).
The program encourages schools and teachers to integrate active strategies into the classroom, school grounds and via students in the home setting to promote physical activity and reduce sedentary behaviour. Strategies include:
CLASSROOM:
* Teachers delivering class room lessons. Lessons teach children strategies to reduce sitting time and increase physical activity at school and at home. Example lesson templates are provided to schools. There will be 9 x 30-40 minute class lessons delivered per year for children in grades 3-6 (effectiveness trial) and prep-6 (implementation trial).
* Teachers are asked to deliver one 30-minute standing/moving lesson each day. These are included as part of normal planned lessons. The content of the lesson remains as planned, rather it is the delivery of the lesson (standing) that changes. Examples of ways to incorporate standing lessons are provided to schools.
* After every 30-minute teaching session sitting, teachers are asked to incorporate short (two-minute) light-intensity classroom-based breaks. For example standing, stretching or walking around the room. Examples of activities are provided to schools.
SCHOOL GROUNDS:
* Schools can install asphalt line markings in the playground to encourage children to be active.
* Teachers are asked to display signage/posters promoting physical activity in areas where students play at recess and lunchtime. I.e. in the school grounds, classroom and staffroom. Examples of signage are provided to schools.
* Use of and providing access to equipment. This includes class sets of pedometers, timers, easels, soft indoor sports circus equipment, such as: balls, bats, ropes and ribbons to use during recess and lunchtime. Schools can use existing or purchase additional equipment.
* Teachers are asked to encourage and praise children for being active during recess and lunchtime through staff supervision and use of the sports and activity equipment, signage and asphalt line markings. Examples are provided if needed by schools.
AT HOME:
* Teachers are asked to modify children’s homework tasks to include a moving/standing component, and set physical activity as homework with parents/family. Existing homework tasks can be used, just modified.
* Parents are provided with nine newsletters per year matched to the nine class lessons. Newsletters reinforce the class lessons, as well as engaging with children’s families. Newsletters are provided to schools, but they can embed the messages into their existing school newsletters.

This intervention will commence in grade 3 and continue until children complete grade 6 i.e. The total duration of the intervention period is four years (effectiveness trial) and will commence in any grade level, prep-6, for implementation trial.

As this is a real-world trial, teachers and schools will choose which components of the program they wish to adopt. The aim of the effectiveness trial is to determine the real world effectiveness and maintenance of the Transform-Us! roll out. This will be assessed from 20 Victorian primary schools who intend on adopting the Transform-Us! program. The aim of the implementation trial is to assess the reach, adoption, implementation (fidelity) and maintenance (at the organisational level) of the program, and will include counts and proportions adopting the program in different schools. Qualitative research, such as key informant interviews, will identify adaptation and assess systems and organisational influences on implementation and maintenance.
Intervention code [1] 296916 0
Behaviour
Intervention code [2] 296917 0
Prevention
Intervention code [3] 297029 0
Lifestyle
Comparator / control treatment
For effectiveness, all schools in Victoria will be eligible to adopt the program; therefore, a suitable control group cannot be established in Victoria.
A current practice, control arm consisting of 20 NSW primary schools matched for similar size and area level disadvantage will act as the comparison group. These schools will not be implementing similar health or physical activity-related programs. There is no comparator/control group for the implementation trial.
Control group
Active

Outcomes
Primary outcome [1] 300800 0
Effectiveness Primary Outcomes: Children’s average minutes per day of moderate- to vigorous- intensity physical activity and sedentary time assessed using hip-mounted ActiGraph accelerometers. Children wear the accelerometers during waking hours for eight days at each measurement point.
Timepoint [1] 300800 0
Baseline- 2018-2019
T2- 2019-2020
T3- 2020-2021
Primary outcome [2] 300801 0
Implementation Primary Outcome 1: Reach and Adoption will be calculated by comparing all eligible schools in Victoria with registration data. We will also conduct interviews with our partners who helped with dissemination.
Timepoint [2] 300801 0
Baseline- 2018-2022 (Partially collected due to COVID-19 restrictions) T2- 2019-2022 (Partially collected due to COVID-19 restrictions) T3- 2020-2022 (Partially collected due to COVID-19 restrictions) T4- 2022-2023 (Partially collected due to COVID-19 restrictions)
Primary outcome [3] 300916 0
Implementation Primary Outcome 2: Implementation and Organisational Maintenance will be assessed via survey and interview data with school leaders, teachers, and our partners.
Timepoint [3] 300916 0
Baseline- 2018-2022 (Partially collected due to COVID-19 restrictions) T2- 2019-2022 (Partially collected due to COVID-19 restrictions) T3- 2020-2022 (Partially collected due to COVID-19 restrictions) T4- 2022-2023 (Partially collected due to COVID-19 restrictions)
Secondary outcome [1] 330888 0
Effectiveness Secondary Outcome 1 Body Mass Index (BMI) (kg/m2), obtained via height and weight assessments without shoes, using a portable stadiometer and digital scales, performed by trained research staff privately at school. BMI will be calculated and converted as recommended for analysis of longitudinal adiposity data. Children will also be categorised as healthy weight or overweight/obese based on International Obesity Task Force definitions.
Timepoint [1] 330888 0
Baseline- 2018-2019 T2- 2019-2020 (Partially collected due to COVID-19 restrictions) T3- 2020-2021 (Not collected due to COVID-19 restrictions)
Secondary outcome [2] 330889 0
Effectiveness Secondary Outcome 2, Waist circumference, assessed using a flexible tape measure at the level of the narrowest point between the lower costal border and the iliac crest (or the midpoint if not obvious) by trained research staff privately at school. Sex and age-specific waist circumference thresholds for children that correspond to clustering of cardiovascular disease risk factors will be applied
Timepoint [2] 330889 0
Baseline- 2018-2019 T2- 2019-2020 (Partially collected due to COVID-19 restrictions) T3- 2020-2021 (Not collected due to COVID-19 restrictions)
Secondary outcome [3] 330890 0
Effectiveness Secondary Outcome 3: Children’s average minutes per weekday and during school hours of moderate- to vigorous- intensity physical activity and sedentary time assessed using hip-mounted ActiGraph accelerometers. Children wear the accelerometers during waking hours for eight days at each measurement point.
Timepoint [3] 330890 0
Baseline- 2018-2019 T2- 2019-2020 T3- 2020-2021

Eligibility
Key inclusion criteria
We will be inviting Grade 4 children to test the Effectiveness of the program (in addition to Grade 3 children). We will be inviting Grade prep-6 children for the Implementation trial.
Minimum age
5 Years
Maximum age
12 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
On ethical grounds, there will be no exclusion criteria for participants, however, potential confounders will be asses using parent report of their child’s health.
Potential participant Primary Schools will undergo an audit of current policies that have already have relevant action plans or programs in place will be excluded.

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)
N/A
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
N/A
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
For the effectiveness trial we aim to recruit a total of 1,094 children, in year 3 and 4 (n=547 in Victoria, n=547 in NSW) across 40 primary schools (n=20 intervention schools in Victoria, n=20 matched-control schools in NSW).
Based on estimates from the original cluster-RCT, to account for the design effect, an ICC of 0.03 for children within clusters was used, with a conservative correlation of 0.015 assumed between two different pupils within a cluster at different time points and a correlation of 0.22 between the same pupils at different time points. Assuming alpha=0.05, 80% power will be available to detect a 16-minute difference in sedentary time (two-thirds that observed in the efficacy trial as differences may be smaller at scale) between intervention and control, 1094 children are required (547 from intervention and control schools, assuming 28 students/school sampled). This number is sufficient to detect as small an effect as a 6-minute difference in physical activity between the control and intervention schools.

For the Implementation trial, all collected data will be integrated and mapped against the five RE-AIM components. All schools in Victoria are eligible to participate in Transform-Us!, therefore, the total number of schools in the State (potentially eligible) and the total number who register (actual recipients) will be used to estimate the rate of Adoption (Aim 3). Calculation of participant Reach (Aim 1) will be two-fold. Firstly, all teachers/children in registered schools will be classified as potentially exposed to the program. The total number of program recipients compared to the total number eligible will represent one measure of potential reach. However, teachers could register and complete program training without a school being registered, or be included within a participating school but chose not to complete training. Therefore, we will also compare the number of teachers completing training (actual training recipients) versus the total number of teachers in Victorian schools (potentially eligible for training) as an additional measure of program reach. - To assess the effectiveness (Aim 2) and individual-level maintenance (Aim 5) of Transform-Us! at scale, a parallel arm pre-post design with follow-up will be used. All schools in Victoria will be eligible to adopt the program; therefore, a suitable control group cannot be established in Victoria. A step-wedge design that negates the need for a control group is not suitable as schools would have to wait to receive the program and there is potential for between-school contamination. Therefore, suitable control schools, matched with intervention schools according to school size and socioeconomic status, will be selected from NSW. Of the 1786 primary schools in Victoria, it is anticipated that 40% (based on uptake of previous Victorian DET initiatives and implementation trials in schools5)will register and send teachers to training for Transform-Us!.
To examine whether there are ‘thresholds’ of delivery required to detect a program effect, we will perform moderating analyses at post-intervention and 1-year follow-up (Aim 4). For example, outcomes in schools that deliver 50% of the program will be compared to schools that deliver <50% of the program. We will also examine which particular components are vital for success. Three levels of clustering will be accounted for in the multilevel analyses: 1) student; 2) class; 3) school. Data from qualitative interviews and focus groups will be analysed thematically using NVivo10

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
1/04/2017
Actual
6/11/2017
Date of last participant enrolment
Anticipated
28/06/2019
Actual
3/12/2019
Date of last data collection
Anticipated
31/12/2023
Actual
Sample size
Target
1094
Accrual to date
Final
1370
Recruitment in Australia
Recruitment state(s)
NSW,VIC

Funding & Sponsors
Funding source category [1] 295381 0
Government body
Name [1] 295381 0
NHMRC
Country [1] 295381 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] 294203 0
Government body
Name [1] 294203 0
VicHealth
Address [1] 294203 0
VicHealth
PO Box 154, Carlton South, VIC 3053
15-31 Pelham Street , Carlton VIC 3053
Country [1] 294203 0
Australia
Secondary sponsor category [2] 294298 0
Government body
Name [2] 294298 0
National Health and Medical Research Council
Address [2] 294298 0
NHMRC
GPO Box 1421, Canberra ACT 2601
Level 5, 20 Allara Street, Canberra City ACT
Country [2] 294298 0
Australia
Other collaborator category [1] 279401 0
Government body
Name [1] 279401 0
Department of Education and Training
Address [1] 279401 0
DET
2 Treasury Place
East Melbourne, VIC 3002
Country [1] 279401 0
Australia
Other collaborator category [2] 279402 0
Other
Name [2] 279402 0
Independent Schools Victoria
Address [2] 279402 0
40 Rosslyn Street
West Melbourne, VIC 3003
Country [2] 279402 0
Australia
Other collaborator category [3] 279403 0
Other
Name [3] 279403 0
Victorian Principals Association
Address [3] 279403 0
Unit 2, 13-21 Vale Street
North Melbourne, VIC 3051
Country [3] 279403 0
Australia
Other collaborator category [4] 279404 0
Other
Name [4] 279404 0
The Australian Council for Health, Physical Education and Recreation
Address [4] 279404 0
Suite 1, 651 Victoria Street
Abbotsford, VIC 3067
Country [4] 279404 0
Australia
Other collaborator category [5] 279405 0
Other
Name [5] 279405 0
PEAK Phys Ed
Address [5] 279405 0
PO BOX 4033
Balwyn East, VIC 3103
Country [5] 279405 0
Australia
Other collaborator category [6] 281162 0
Other
Name [6] 281162 0
Catholic Education Melbourne
Address [6] 281162 0
228 Victoria Parade
East Melbourne
Victoria 3002
Country [6] 281162 0
Australia
Other collaborator category [7] 281163 0
Government body
Name [7] 281163 0
Municipal Association of Victoria:
Address [7] 281163 0
Level 12, 60 Collins St,
Melbourne VIC 3000
Country [7] 281163 0
Australia
Other collaborator category [8] 281164 0
Government body
Name [8] 281164 0
Victorian Curriculum and Assessment Authority
Address [8] 281164 0
Level 7, 2 Lonsdale Street
Melbourne VIC 3000
Country [8] 281164 0
Australia
Other collaborator category [9] 281165 0
Government body
Name [9] 281165 0
Department of Health and Human Services
Address [9] 281165 0
50 Lonsdale Street
Melbourne, Victoria, Australia
3000
Country [9] 281165 0
Australia
Other collaborator category [10] 281166 0
Other
Name [10] 281166 0
Cancer council Victoria
Address [10] 281166 0
615 St Kilda Road,
Melbourne, Victoria, 3004, Australia
Country [10] 281166 0
Australia
Other collaborator category [11] 281167 0
Charities/Societies/Foundations
Name [11] 281167 0
Bluearth
Address [11] 281167 0
50 Rouse Street, Port Melbourne,
Melbourne, VIC 3207
Country [11] 281167 0
Australia
Other collaborator category [12] 281168 0
Other
Name [12] 281168 0
Hawthorn Football club
Address [12] 281168 0
Ricoh Centre, Waverley Park
Stadium Circuit Mulgrave VIC 3170
PO Box 829 Mt Waverley VIC 3149
Country [12] 281168 0
Australia
Other collaborator category [13] 281169 0
Government body
Name [13] 281169 0
Sport Australia: Sporting Schools
Address [13] 281169 0
Leverrier Street
Bruce ACT 2617
PO Box 176
BELCONNEN ACT 2616
Country [13] 281169 0
Australia
Other collaborator category [14] 281170 0
Other Collaborative groups
Name [14] 281170 0
DPV Health
Address [14] 281170 0
2 Graystone Court
Epping 3076
VIC, Australia
Country [14] 281170 0
Australia
Other collaborator category [15] 281171 0
Government body
Name [15] 281171 0
Sport and Recreation Victoria
Address [15] 281171 0
50 Lonsdale Street
Melbourne, Victoria, Australia
3000
Country [15] 281171 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 296716 0
Human Research Ethics Committee
Ethics committee address [1] 296716 0
Ethics committee country [1] 296716 0
Australia
Date submitted for ethics approval [1] 296716 0
24/02/2017
Approval date [1] 296716 0
27/04/2017
Ethics approval number [1] 296716 0
HEAG-H 28_2017

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

Contacts
Principal investigator
Name 69898 0
Prof Jo Salmon
Address 69898 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 69898 0
Australia
Phone 69898 0
+61 03 92517254
Fax 69898 0
Email 69898 0
[email protected]
Contact person for public queries
Name 69899 0
Jo Salmon
Address 69899 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 69899 0
Australia
Phone 69899 0
+61 03 92517254
Fax 69899 0
Email 69899 0
[email protected]
Contact person for scientific queries
Name 69900 0
Jo Salmon
Address 69900 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 69900 0
Australia
Phone 69900 0
+61 03 92517254
Fax 69900 0
Email 69900 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
SourceTitleYear of PublicationDOI
EmbaseScaling up a school-based intervention to increase physical activity and reduce sedentary behaviour in children: Protocol for the TransformUs hybrid effectiveness-implementation trial.2023https://dx.doi.org/10.1136/bmjopen-2023-078410
N.B. These documents automatically identified may not have been verified by the study sponsor.