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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
18/01/2019
Date data sharing statement initially provided
8/01/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Efficacy of the Transform-Us! program for increasing physical activity and reducing prolonged sitting time in Victorian primary school children.

Scientific title
Scalability of the Transform-Us! program to promote children’s physical activity and reduce prolonged sitting time in Victorian primary schools- Effectiveness Trial
Secondary ID [1] 290383 0
None
Universal Trial Number (UTN)
Trial acronym
Transform-Us!
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.
* 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.

As this is a real-world trial, teachers and schools will choose which components of the program they wish to adopt. The aim of this 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.
Intervention code [1] 296916 0
Behaviour
Intervention code [2] 296917 0
Prevention
Intervention code [3] 297029 0
Lifestyle
Comparator / control treatment
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.
Control group
Active

Outcomes
Primary outcome [1] 300800 0
Primary Outcome 1: Physical activity will be objectively assessed using hip-mounted ActiGraph accelerometers. Children wear the accelerometers during waking hours for eight days at each measurement point. Movement count thresholds (based on age-specific energy expenditure prediction equations) will be used to calculate the average time spent being sedentary, number of breaks to sedentary time, and time spent in moderate- and vigorous- intensity activity. Accelerometry data from specific times of the day (eg, after-school hours, during class time) will be extracted to identify when changes in physical activity or sedentary behaviour occurred.

Timepoint [1] 300800 0
Baseline- 2018-2019
T2- 2019-2020
T3- 2020-2021
Primary outcome [2] 300801 0
Primary Outcome 2: Behavioural information on the types of activities in which children participate as well as children’s enjoyment and awareness of the program. This is a composite primary outcome that will be assessed using surveys designed for this study.

Timepoint [2] 300801 0
Baseline- 2018-2019
T2- 2019-2020
T3- 2020-2021
Primary outcome [3] 300916 0
Primary Outcome 3: . Parents perception of childs physical activity and their awareness for the program, assessed using online surveys designed for this study. This is a composite primary outcome that will be assessed using surveys designed for this study.
Timepoint [3] 300916 0
Baseline- 2018-2019
T2- 2019-2020
T3- 2020-2021
Secondary outcome [1] 330888 0
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
T3- 2020-2021
Secondary outcome [2] 330889 0
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
T3- 2020-2021
Secondary outcome [3] 330890 0
School audit- Principal surveys will capture descriptive characteristics of the school (i.e. size, type), the program components they intend to implement (i.e. curriculum only content and/or school playground markings) and existing policies or practices as well as capturing changes to program delivery over time

Timepoint [3] 330890 0
Baseline- 2018-2019
T2- 2019-2020
T3- 2020-2021
Secondary outcome [4] 330891 0
Implementation- Teachers surveys will capture participant demographics, perception of program need and intended program implementation. As well as changes in teacher delivery and perceptions of barriers and facilitators over time.
Timepoint [4] 330891 0
Baseline- 2018-2021
T2- 2019-2021
T3- 2020-2021
T4- 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).
Minimum age
6 Years
Maximum age
11 Years
Gender
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
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.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,VIC

Funding & Sponsors
Funding source category [1] 295381 0
Government body
Name [1] 295381 0
NHMRC
Address [1] 295381 0
NHMRC
GPO Box 1421, Canberra ACT 2601
Level 5, 20 Allara Street, Canberra City ACT
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

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 296716 0
Human Research Ethics Committee
Ethics committee address [1] 296716 0
Human Research Ethics Committee - NEAF
National Health and Medical Research Council
GPO BOX 1421
Canberra, ACT 2601
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
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).
To determine real world effectiveness and maintenance (at the individual level), a quasi-experimental pre post non-equivalent group design with follow up will be used. A sub-sample of 20 schools from different socioeconomic urban and rural areas of Victoria will be selected and 20 schools of similar size and area-level disadvantage in NSW not implementing similar health or physical activity-related programs will be recruited as matched controls.
Our findings will determine the effectiveness of implementing an efficacious program at scale so that it can be rolled out nationally and become part of routine best practice.
Trial website
www.transformus.com.au
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
jo.salmon@deakin.edu.au
Contact person for public queries
Name 69899 0
Prof 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
transformus@deakin.edu.au
Contact person for scientific queries
Name 69900 0
Prof 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
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 other documents available
Summary results
No Results