Trial Review

The ANZCTR website will be unavailable from 1pm until 3pm (AEDT) on Wednesday the 30th of October for website maintenance. Please be sure to log out of the system in order to avoid any loss of data.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12624001159549
Ethics application status
Approved
Date submitted
8/07/2024
Date registered
24/09/2024
Date last updated
24/09/2024
Date data sharing statement initially provided
24/09/2024
Type of registration
Retrospectively registered

Titles & IDs
Public title
TransformUs Wellbeing: Feasibility of a multicomponent school-based systems intervention within Victorian primary schools.
Scientific title
A cluster-randomised controlled trial examining the effectiveness of a multicomponent school-based systems intervention (TransformUs Wellbeing) on determinants of childhood obesity within Victorian primary schools.
Secondary ID [1] 311641 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record
This study is an extension of ACTRN12617000204347 and ACTRN12618001986268. The TransformUs Wellbeing study is incorporating systems science and co-design approach used in RESPOND and embedding in the existing TransformUs intervention and further including diet, sleep and wellbeing.

Health condition
Health condition(s) or problem(s) studied:
Obesity 333093 0
Poor nutrition 333094 0
Physical inactivity 333095 0
Sleep insufficiency 333096 0
Mental wellbeing 333097 0
Condition category
Condition code
Public Health 329781 329781 0 0
Health promotion/education
Diet and Nutrition 329782 329782 0 0
Obesity
Mental Health 329783 329783 0 0
Studies of normal psychology, cognitive function and behaviour

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
TransformUs Wellbeing builds on the successfully scaled-up primary school physical activity and sedentary behaviour intervention in Victoria (TransformUs) which currently reaches over 500 schools and the whole of community systems intervention called RESPOND (Reflexive Evidence and Systems interventions to Prevent Obesity and Non-communicable Disease (RESPOND). TransformUs Wellbeing will expand and optimise the existing interventions to further to include diet quality, sleep sufficiency and wellbeing and incorporate systems approach within the primary school setting.

It is best described as an educational intervention, whereby, school and community leaders participate in workshops designed to understand the problem (e.g. childhood wellbeing) and then design and implement intervention actions to improve behaviours that can improve wellbeing (e.g. physical activity, sedentary behaviour, diet quality and sleep sufficiency). TransformUs Wellbeing is a cluster RCT involving 8 intervention and 8 control primary schools across three regional Victoria [Warrnambool, Moyne and Corangamite] local government areas (LGAs). There are 3 phases of the intervention which are described below.

Stage 1 - Monitoring (Intervention and control schools): Data provides the first and critical step in the school engagement process. At baseline in Term 2 2024, we will conduct a census styled (e.g. all primary schools invited (n =35) health behaviour monitoring system across the 3 LGAs to examine current estimates of physical activity, sedentary behaviour, diet quality, sleep sufficiency and wellbeing among students in Grade 2, 3, 4 and 5. We will again conduct these measurements post-intervention in Term 2, 2025 among intervention schools-only. E.g. All n= 35 primary schools will be invited in 2024 and only 16 intervention/control schools in 2025.

Children in Year 2, Year 3, Year 4 and Year 5 (as well as Year 6 in 2025) will be invited to participate in this research study using an opt-out approach. At each participating school, a 3–5-minute presentation about the study and what participation involves will be made to all students (in Year 2 - Year 5) in a language that is appropriate for their age level. At the conclusion of this presentation, the Plain Language Statement and Opt-Out form will be distributed to students. A newsletter item about the study will also be offered to participating schools to put in their school communication platforms, in addition, schools will be offered the opportunity to email the Plain Language Statement and Opt-Out form to parents/guardians or via their electronic communication platforms.

Students in Year 2, Year 3, Year 4 and Year 5 will be invited to wear a wrist-worn activity monitor (ActiGraph wGT3X-BT) (like a Fitbit) for 24-hours a day over the proceeding 7-days. Students in Year 4 and Year 5 will be invited to complete a self-report electronic questionnaire on their physical activity, sedentary behaviours, diet intake, sleep and health-related quality of life (approx. 30 mins) in class-time. Students will be informed that their participation is voluntary, and they can participate in as much (e.g. just questionnaire) or as little (e.g. not participate at all) in the study as they wish. Their verbal assent will be sought at all stages of data collection.

Stage 2 - Community engagement (Intervention Schools): Working with key leaders within intervention schools [e.g. students, school leadership (Principal, Leading Teachers), health service staff, local council, parents/guardians etc.] the research team will lead the workshops to develop a visual understanding of the drivers of childhood obesity/wellbeing within the community by developing a causal loop diagram (CLD) or systems map. This will be completed in 2x2hr online/face-to-face workshops with key leaders (workshop session one and workshop session two). The 8 intervention primary schools after randomisation are likely to be grouped into clusters of (2-3 schools) based on geographic and/or school-size (e.g. small, medium, large schools). Schools will nominate how they would like to be grouped after randomisation in 2024. Each cluster group is likely to involve 10-20 key leaders for workshop session one and workshop session two (e.g. 20 x 4 = 80 persons).

As part of workshop session two, the CLD will be finalised and priority actions for each theme area (e.g. physical activity, sedentary time, sleep, wellbeing, diet quality) will be developed. TransformUs evidence informed actions will be used around physical activity and sedentary behaviour (e.g. Active breaks, Active lessons, Active homework, Active environments) and current literature on sleep (e.g. stress management and sleep education), dietary (e.g. food literacy classes, food tasting, school gardens) and wellbeing (e.g. social and emotional learning) interventions for workshop participants to select. Working groups around each priority theme will be developed to enhance implementation of identified actions for each school cluster group. These working groups will be supported in Stage 3 to implement these actions (see below).

Workshops will be held at a public community venue (e.g. school, community hall, public library) if held in person, and via zoom or teams if held online (they will not be audio/video recorded). As part of the group model building (GMB) process, there is a designated facilitator who takes notes on the conversations held, to ensure critical information is not missed. The time period between workshops is yet to be determined, however, it is anticipated that workshop session two would occur no more than one month after workshop session one.

Stage 3 - Implementation of actions: This will occur immediately after Stage 2, with an overall duration of 9 months. Intervention experience will vary depending on the types/number of bespoke activities implemented by each school (e.g., health lessons, extra-curricular activities, policy development etc.).

The intervention will be administered by teachers/school staff with the support of researchers. Ongoing support sessions with key leaders and working groups with each cluster group will be conducted every 1-2 months online (frequency decided by key leaders/cluster group) to discuss barriers and facilitators to implementation and support implementation efforts. The research team will lead these peer mentoring/implementation support sessions to enable mutual learning and sharing of case studies and processes. It is envisaged that these sessions will last 1-2 hrs every 1-2 months per cluster group (e.g. 6x 2hrs = 8 hrs over 9 months). These sessions will occur via Zoom/Teams and will not be audio or video recorded.
Intervention code [1] 328104 0
Prevention
Comparator / control treatment
At the conclusion of baseline monitoring, 16 schools will be randomised 1:1 intervention to control. The control schools will not receive any additional activities or support, however, specifically designed resources on how to implement intervention actions will be made available to control schools at the conclusion of the intervention.
Control group
Active

Outcomes
Primary outcome [1] 337573 0
Wellbeing
Timepoint [1] 337573 0
Grade 4 and Grade 5 at baseline, and immediately post-intervention (approx. 9-months after baseline).
Secondary outcome [1] 432356 0
Moderate-to-vigorous physical activity
Timepoint [1] 432356 0
Grade 4 and Grade 5 at baseline, and immediately post-intervention (approx. 9-months after baseline).
Secondary outcome [2] 432357 0
Sedentary behaviour
Timepoint [2] 432357 0
Grade 4 and Grade 5 at baseline, and immediately post-intervention (approx. 9-months after baseline).
Secondary outcome [3] 432358 0
Sleep duration
Timepoint [3] 432358 0
Grade 4 and Grade 5 at baseline, and immediately post-intervention (approx. 9-months after baseline).
Secondary outcome [4] 432359 0
Diet quality - Fruit intake
Timepoint [4] 432359 0
Grade 4 and Grade 5 at baseline, and immediately post-intervention (approx. 9-months after baseline).
Secondary outcome [5] 437776 0
Moderate-to-vigorous physical activity
Timepoint [5] 437776 0
Grade 2, 3, 4, 5 at baseline, and immediately post-intervention (approx. 9-months after baseline).
Secondary outcome [6] 437777 0
Sedentary behaviour
Timepoint [6] 437777 0
Grade 2, 3, 4, 5 at baseline, and immediately post-intervention (approx. 9-months after baseline).
Secondary outcome [7] 437778 0
Sleep duration
Timepoint [7] 437778 0
Grade 2, 3, 4, 5 at baseline, and immediately post-intervention (approx. 9-months after baseline).
Secondary outcome [8] 440000 0
Diet quality- vegetable intake
Timepoint [8] 440000 0
Grade 4 and Grade 5 at baseline, and immediately post-intervention (approx. 9-months after baseline).

Eligibility
Key inclusion criteria
All children in Grade 2, 3, 4 and 5 in participating primary schools in the Warrnambool, Corangamite and Moyne LGAs of South-West Victoria will be invited to participate in the monitoring component (n=35 schools).

This trial is conducted in the real-world school setting. Entire schools are randomised to intervention or control and individual participants are not singled out.

Inclusion criteria for the group model building workshop sessions will be based on facilitators judgement of the best placed school/community leaders/stakeholders who can generate community interest and buy-in for a community-led obesity prevention effort.

There are no school-based inclusion criteria.
Minimum age
7 Years
Maximum age
13 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
There are no exclusion criteria for the monitoring component. All children in Grade 2, Grade 3, Grade 4 and Grade 5 at participating schools will be invited to participate.

There are no exclusion criteria set for the group model building workshop sessions and or intervention school enrolment.

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



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis
Statistical analyses of primary (HRQol) and secondary outcomes (physical activity, sedentary behaviour, sleep, and diet quality) will be examined using an intention to treat analyses.

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
Actual
15/04/2024
Date of last participant enrolment
Anticipated
Actual
28/06/2024
Date of last data collection
Anticipated
19/09/2025
Actual
Sample size
Target
640
Accrual to date
Final
759
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 315967 0
Government body
Name [1] 315967 0
VicHealth
Country [1] 315967 0
Australia
Primary sponsor type
University
Name
Deakin University
Address
Country
Australia
Secondary sponsor category [1] 318237 0
Government body
Name [1] 318237 0
VicHealth
Address [1] 318237 0
Country [1] 318237 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 314791 0
Deakin University Human Research Ethics Committee (DUHREC)
Ethics committee address [1] 314791 0
Ethics committee country [1] 314791 0
Australia
Date submitted for ethics approval [1] 314791 0
27/10/2023
Approval date [1] 314791 0
31/01/2024
Ethics approval number [1] 314791 0
DU-HREC 2023- 361
Ethics committee name [2] 314891 0
Research in Schools and Early Childhood Settings (RISEC)
Ethics committee address [2] 314891 0
Ethics committee country [2] 314891 0
Australia
Date submitted for ethics approval [2] 314891 0
06/02/2024
Approval date [2] 314891 0
01/05/2024
Ethics approval number [2] 314891 0
24-01-238

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

Contacts
Principal investigator
Name 132742 0
Dr Claudia Strugnell
Address 132742 0
Deakin University, Insitute of Physical Activity and Nutrition, 221 Burwood Hwy, Burwood, VIC 3125
Country 132742 0
Australia
Phone 132742 0
+61 3 5227 8483
Fax 132742 0
Email 132742 0
[email protected]
Contact person for public queries
Name 132743 0
Claudia Strugnell
Address 132743 0
Deakin University, Insitute of Physical Activity and Nutrition, 221 Burwood Hwy, Burwood, VIC 3125
Country 132743 0
Australia
Phone 132743 0
+61 3 5227 8483
Fax 132743 0
Email 132743 0
[email protected]
Contact person for scientific queries
Name 132744 0
Claudia Strugnell
Address 132744 0
Deakin University, Insitute of Physical Activity and Nutrition, 221 Burwood Hwy, Burwood, VIC 3125
Country 132744 0
Australia
Phone 132744 0
+61 3 5227 8483
Fax 132744 0
Email 132744 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
No individual participant data will be shared due to the privacy and confidentiality as per ethics application


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
23966Ethical approval  [email protected]



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.