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TransformUs Wellbeing: Feasibility of a multicomponent school-based systems intervention within Victorian primary schools.

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.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12624001159549
Enrollment
759
Registered
2024-09-24
Start date
2024-04-15
Completion date
2024-06-28
Last updated
2024-09-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

This research will develop, test, and disseminate a multicomponent childhood obesity intervention for primary schools in South-West Victoria. The innovative TransformUs Wellbeing intervention builds on the successfully scaled-up primary school physical activity behaviour intervention in Victoria (TransformUs) and multi-component WHO STOPS community-based childhood obesity intervention. We hypothesise that by embedding capacity in systems thinking and mapping within primary school settings, and extending on the risk behaviours (e.g. diet quality, physical activity, sedentary behaviour, and sleep sufficiency and mental wellbeing) will lead to greater impacts and sustained changes in key behavioural drivers of childhood obesity. Our aim is test the effectiveness of TransformUs Wellbeing on health-related quality of life through a 9-month cluster-RCT among 8 intervention and 8 control primary schools in South-West Victoria in 2024.

Interventions

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 we

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.

Sponsors

Deakin University
Lead SponsorUniversity

Study design

Allocation
Randomised controlled trial
Primary purpose
Prevention

Eligibility

Sex/Gender
All
Age
7 Years to 13 Years
Healthy volunteers
Yes

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.

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.

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026