Trial Review

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Trial registered on ANZCTR


Registration number
Help: Registration number
ACTRN12626001041347
Ethics application status
Help: Ethics application status
Approved
Date submitted
Help: Date submitted
27/07/2026
Date registered
Help: Date registered
25/08/2026
Date last updated
Help: Date last updated
25/08/2026
Date data sharing statement initially provided
Help: Data sharing statement date
25/08/2026
Type of registration
Help: Type of registration
Retrospectively registered

Titles & IDs
Public title
A randomised trial of an intervention to sustain the implementation of a healthy lunchbox initiative in primary schools
Scientific title
Evaluation of an intervention to sustain primary school implementation of a technology-based healthy lunchbox initiative: a randomised controlled trial
Additional trial identifiers [1] 318018 0
Nil
Universal Trial Number (UTN)
Trial acronym
Related trial records

Health condition
Health condition(s) studied:
Obesity 343020 0
Condition category
Condition code
Public Health 339113 339113 0 0
Health promotion/education
Diet and Nutrition 339114 339114 0 0
Obesity

Intervention/exposure
Study type
Interventional
Description of the intervention or exposure
A randomised controlled trial will be used to test the effectiveness of a 6-month theory-based multi-component strategy to sustain the implementation of a healthy lunchbox program within NSW primary schools located within 12 Local Health Districts of NSW.

The healthy lunchbox program (‘SWAP IT’) consists of electronic messages sent to parents/carers via usual school-parent communication channels (10 weekly messages in the initial school term, followed by 2 messages per term ongoing), together with school nutrition guideline implementation, curriculum/classroom resources, and parent resources. The SWAP IT program aims to improve the contents of children’s lunchboxes by supporting parents/carers to swap what is packed from discretionary (“sometimes”) foods and drinks to core (“everyday”) foods and drinks.

The intervention of interest in this study is the intervention to sustain the implementation of SWAP IT. Sustained implementation of the program is defined as the distribution of 2 electronic healthy lunchbox messages to parents/carers per term ongoing.

The sustainability intervention will run for approximately 6 months (2 NSW school terms) following allocation to the intervention group. It will comprise seven sustainability strategies designed to support schools to continue implementation of SWAP IT as follows:

1. Develop and distribute educational materials
Who: Local Health District health promotion staff will develop and distribute materials to school key contacts, who will share relevant resources with school staff and the wider school community.
What: Educational materials will include:
-an updated SWAP IT program guide containing an overview of the program and its components; the role and responsibilities of the school key contacts; actions required each term to sustain implementation; links to training and program resources; information about accessing support; the benefits of continuing SWAP IT; information addressing food insecurity and the cost of healthy eating; and a prompt to include SWAP IT implementation in the school workplan;
-an updated healthy lunchbox guideline/policy template outlining the importance of healthy lunchboxes, examples of healthy lunchboxes, how the school supports healthy lunchboxes, and formal school endorsement of continued SWAP IT implementation;
-new parent factsheets providing practical information on budget-friendly healthy lunchboxes, food affordability and food security, and nude food/waste-free lunchbox ideas; and
-links to existing SWAP IT implementation resources, including staff training, lesson plans and other program resources.
When/frequency: The program guide will be distributed by email in weeks 1, 4 and 7 of each school term. The healthy lunchbox guideline/policy will be reviewed and endorsed annually. Parent factsheets will be available throughout the intervention period.
Where/mode: Materials will be delivered electronically via email and made available through the SWAP IT website (portal). Schools will implement the materials within their school setting and may share them with school staff and parents/carers.

2. Develop an implementation glossary
Who: Local Health District health promotion staff will provide implementation information to school key contacts and school staff.
What: The implementation glossary will be incorporated within the updated SWAP IT program guide and will provide clear information about key implementation roles, responsibilities and processes required for ongoing delivery of SWAP IT, including the role of the school key contact.
When/frequency: The glossary will be provided as part of the program guide from commencement of the sustainment intervention and remain available throughout the 6-month intervention.
Where/mode: The glossary will be provided electronically via email within the SWAP IT program guide and on the SWAP IT website.

3. Develop a formal implementation blueprint
Who: School principals/executive staff, school key contacts and Local Health District health promotion staff will be involved.
What: Schools will be provided with an updated healthy lunchbox guideline/policy that serves as a formal implementation blueprint for continued SWAP IT delivery. The guideline will describe the school's support for healthy lunchboxes and continued SWAP IT implementation. The school executive will be asked to formally endorse continued implementation, including ongoing distribution of two SWAP IT messages per term to parents/carers.
When/frequency: Schools will be prompted to review and endorse the guideline/policy once annually. During the 6-month sustainment intervention, Local Health District health promotion staff will engage with schools regarding the guideline/policy as part of ongoing implementation support.
Where/mode: The guideline/policy will be implemented within the school and provided electronically as an A4 document. Local Health District health promotion staff may discuss and support implementation during face-to-face, telephone or other routine service delivery contacts.

4. Remind school key contacts/staff
Who: School key contacts and school staff responsible for distributing SWAP IT messages will receive reminders from the SWAP IT electronic system.
What: Reminder emails will prompt schools to continue implementation, including sharing the scheduled SWAP IT messages with their school community, checking/updating the school key contact details, accessing program resources, and seeking support where required. The emails will also reinforce the benefits, feasibility and flexibility of continuing SWAP IT.
When/frequency: Automated reminder emails will be sent during weeks 1, 4 and 7 of each school term during the sustainment period. The week 1 email will re-engage schools and prepare them for the upcoming messages, while weeks 4 and 7 emails will prompt distribution of the scheduled SWAP IT messages.
Where/mode: Emails will be automatically distributed through the SWAP IT website to the school key contact and/or nominated reminder email address. The school key contact and relevant school staff will then distribute the SWAP IT messages to parents/carers through the school's usual communication channels.

5. Provide local technical assistance and local facilitation
Who: Local Health District health promotion staff will provide support to school key contacts.
What: Health promotion staff will contact schools to check for changes in school key contacts, confirm ongoing distribution of SWAP IT messages, identify barriers to implementation, problem solve implementation challenges, reinforce the benefits and minimal time burden of the program, provide technical assistance, and support ongoing implementation. Staff will also remind schools about relevant program resources, annual distribution of parent resources, and review of healthy lunchbox guidelines/policies.
When/frequency: Contact will occur at least once during the intervention period and may also occur as part of routine service delivery. Two active contact attempts are encouraged before an email will used as a final contact attempt.
Where/mode: Contact will occur via face-to-face meetings, telephone/video calls or email.

6. Promote adaptability and tailor strategies
Who: Local Health District health promotion staff will provide the message bank to school key contacts, who will select and distribute messages to parents/carers according to their school's context.
What: A new bank of SWAP IT messages will provide alternative messages for schools that have identified food insecurity and/or environmental sustainability as concerns within their school community. Messages will address food affordability and food insecurity, including low-cost healthy lunchbox options, as well as nude foods and environmental sustainability. The message bank will allow schools to select messages relevant to their local context and priorities.
When/frequency: The message bank will be made available throughout the sustainment period and promoted through reminder emails in weeks 4 and 7 of each school term. Schools may select and rotate messages when repeating the program.
Where/mode: Messages will be available as downloadable PDF/social media tiles through the SWAP IT website. School key contacts will select and distribute messages through their usual school-parent communication channels.

7. Use mass media and capture and share local knowledge
Who: The SWAP IT team will manage and moderate a SWAP IT social media platform. School staff, parents/carers and the wider school community will be the target audience, with schools and LHDs able to contribute and share local experiences.
What: A SWAP IT Facebook page will provide a supportive platform for sharing success stories, case studies and practical approaches to sustaining SWAP IT. The SWAP IT team will also share social media tiles highlighting positive outcomes and implementation experiences and provide information and support regarding the program.
When/frequency: The social media platform will operate throughout the sustainment period, with posts made up to once per week during each school term.
Where/mode: Delivery will occur online through the SWAP IT Facebook page. Content will be delivered through social media posts and interactions moderated by the SWAP IT team.

Delivery and fidelity of the sustainability intervention will be monitored using automated email records, Local Health District implementation monitoring logs, website analytics, message download data and social media engagement metrics.
Intervention code [1] 334893 0
Behaviour
Description of the comparator or control
Schools allocated to the control group will receive light-touch sustainment support for the same 6-month period. This will comprise continued access to the central SWAP IT website/portal and its implementation resources, and reactive support from LHD health promotion staff upon request. No proactive sustainment strategies will be delivered to control schools.
Control group
Active

Outcomes
Primary outcome [1] 346358 0
Proportion of primary schools distributing the recommended number of SWAP IT messages (2 messages per school term) to parents/carers at 6 month follow-up
Timepoint [1] 346358 0
6 month follow-up
Secondary outcome [1] 465515 0
Mean number of SWAP IT messages sent to parents/carers at 6 month follow-up
Timepoint [1] 465515 0
6 month follow-up

Eligibility
Key inclusion criteria
Department of Education (DoE), Catholic and Independent primary schools located within 12 Local Health Districts of NSW (Murrumbidgee, Hunter New England, Sydney, Western Sydney, South Eastern Sydney, Northern Sydney, Western NSW, Nepean Blue Mountains, Illawarra Shoalhaven, Central Coast, Mid-North Coast, Northern NSW). Primary and combined schools who cater for primary school aged children that have implemented the SWAP IT healthy lunchbox program since the beginning of 2023 will form the study sample and will be invited to participate.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Healthy volunteers
No
Key exclusion criteria
Nil

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Primary schools located within the 12 Local Health Districts of NSW that are currently implementing the SWAP IT healthy lunchbox program will serve as the study sample. Prior to the delivery of the first sustainment strategy, schools will be randomly allocated in a 1:1 ratio to either the intervention or control condition using a central, computer-generated randomisation process. Allocation will be conducted centrally to ensure that the allocation sequence is concealed from the study team and schools prior to randomisation.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
An independent statistician will randomise schools, using a computerised random number function, stratified by the Local Health District, school size, and the geographic and socio-economic location of the school (given its association with implementation of school nutrition programs) in a 1:1 (intervention: control) ratio using random block sizes of between 2-6.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
28/05/2026
Date of last participant enrolment
Anticipated
Actual
31/07/2026
Date of last data collection
Anticipated
Actual
31/07/2026
Sample size
Target
476
Accrual to date
Final
212
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 322569 0
Government body
Name [1] 322569 0
Hunter New England Population Health
Country [1] 322569 0
Australia
Primary sponsor type
Government body
Name
Hunter New England Population Health
Address
Country
Australia
Secondary sponsor category [1] 325490 0
University
Name [1] 325490 0
University of Newcastle
Address [1] 325490 0
Country [1] 325490 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 321041 0
Hunter New England Human Research Ethics Committee
Ethics committee address [1] 321041 0
Ethics committee country [1] 321041 0
Australia
Date submitted for ethics approval [1] 321041 0
19/02/2026
Approval date [1] 321041 0
27/03/2026
Ethics approval number [1] 321041 0
Ethics committee name [2] 321044 0
The University of Newcastle Human Research Ethics Committee
Ethics committee address [2] 321044 0
Ethics committee country [2] 321044 0
Australia
Date submitted for ethics approval [2] 321044 0
09/03/2026
Approval date [2] 321044 0
10/03/2026
Ethics approval number [2] 321044 0

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

Contacts
Principal investigator
Name 152470 0
Dr Jannah Jones
Address 152470 0
Hunter New England Population Health; 12 Longworth Ave Wallsend NSW 2287
Country 152470 0
Australia
Phone 152470 0
+61 478 175 669
Fax 152470 0
Email 152470 0
[email protected]
Contact person for public queries
Name 152471 0
Jannah Jones
Address 152471 0
Hunter New England Population Health; 12 Longworth Ave Wallsend NSW 2287
Country 152471 0
Australia
Phone 152471 0
+61 2 4924 6499
Fax 152471 0
Email 152471 0
[email protected]
Contact person for scientific queries
Name 152472 0
Jannah Jones
Address 152472 0
Hunter New England Population Health; 12 Longworth Ave Wallsend NSW 2287
Country 152472 0
Australia
Phone 152472 0
+61 2 4924 6499
Fax 152472 0
Email 152472 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
No
No IPD sharing reason/comment: Individual participant data will not be available for the study as our current ethics approval does not cover this.



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.