Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12623000548639
Ethics application status
Approved
Date submitted
8/05/2023
Date registered
23/05/2023
Date last updated
3/06/2024
Date data sharing statement initially provided
23/05/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
An evaluation into the national scale-up of an effective text message based healthy lunchbox program aimed at improving child nutrition
Scientific title
A randomised control trial to evaluate the national scale-up of an effective school nutrition program to improve child nutrition.
Secondary ID [1] 309597 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record
This trial is associated with ACTRN12623000145606, which is the study evaluating the state-wide scale-up of the effective healthy lunchbox program within New South Wales. The study within this trial registration is an extension of the study described above, and is evaluating the scale-up of the effective healthy lunchbox program in three other states (South Australia, Victoria and Queensland) in addition to New South Wales (which is described in the previous trial registration

Health condition
Health condition(s) or problem(s) studied:
obesity 329906 0
Condition category
Condition code
Public Health 326816 326816 0 0
Health promotion/education
Diet and Nutrition 326817 326817 0 0
Obesity

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
A parallel group randomised controlled trial design will be used to test the effectiveness of a 9-month theory-based multi-component strategy to achieve large scale adoption of an effective healthy lunchbox program (‘SWAP IT’) in primary schools located within Victoria (VIC), Queensland (QLD) and South Australia (SA).

SWAP IT 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. SWAP IT messages are delivered weekly to parents and carers via usual school-parent communication channels for one school term (one message per week), followed by two messages per term on an ongoing basis. The messages provide parents and carers with useful tips and ideas for packing a healthy lunchbox, including recipe ideas and healthy alternatives for ‘sometimes’ foods. Additional resources, including classroom lessons for teachers, school nutrition guidelines and parent booklets, have been specifically developed for the SWAP IT program and are freely available to schools and parents.

Schools allocated to the intervention group within the three states will receive a theoretically-based multi-component dissemination intervention to support schools to register for SWAP IT. The scale up strategy will consist of the following evidence-based components:

1. Program integration: SWAP IT will be integrated into the school communication platform (Audiri) interface routinely used by, and familiar to schools. Specifically, principals will be alerted to program availability via up to four Audiri system pop-ups, prompts and banners, accessible via the user dashboard, and adoption completed via simple click-commands, confirming guideline and message content and timing. The strategies will be delivered in a staggered format throughout the intervention. Once a school registers for the program, they will not receive any additional strategies.

2. Endorsement from state-level health and education stakeholders: State-level policy makers from Education and Health from NSW, VIC, QLD and SA will target principals, to communicate via up to two targeted email, support and endorsement of the program and its outcomes, its alignment to sector policies, recommend its adoption and will provide a link to resources and the enrolment site.

3. Local opinion leaders: Health promotion staff located within each state (SA, QLD and VIC) have developed strong and trusted local relationships with schools for over a decade and represent credible sources of local nutrition expertise. They will use up to three existing school contacts, including email, telephone and face-to-face visits, to assess interest in the program, address any barriers to adoption, and facilitate goal setting and action planning.

4. Educational materials: Targeted at principals and other school decision makers, such as the school administration manager and parent committee to address perceived barriers to adoption, the strategy will initially aim to create tension for change (e.g. via outlining parent interest and expectations); and then communicate the attractive program attributes (e.g. simplicity, no-cost). This communication will consist of up to four contacts, including a combination of email and mailed materials (information booklets, flyers, calendars, curriculum resources, classroom resources).

5. Audit and feedback: Data and feedback on adoption of SWAP IT will be automatically captured via electronic registration records and will be provided to schools via the communication strategy and help guide execution and targeting of components. For example, communication materials provided to principals, school administration managers and parent committees will include information on the number of schools that have registered for SWAP IT and provide instruction on how the school can also register for the program.

The research team will control the delivery of the scale-up strategies, ensuring they are only received by schools in the intervention group. Project records maintained by the research team and collaborating health promotion staff will be used to monitor adherence to the intervention, including the delivery of each scale-up strategy.
Intervention code [1] 326020 0
Behaviour
Comparator / control treatment
The program will appear on the Audiri user dashboard of waitlist control schools only. Schools allocated to the control group will receive the scale-up strategies after the completion of the 9-month follow-up data collection.
Control group
Active

Outcomes
Primary outcome [1] 334659 0
Adoption will be defined as the number of schools who register for the lunchbox nutrition program (SWAP IT) and will be assessed within schools allocated to the intervention and control group via electronic registration records captured automatically following school registration to SWAP IT.
Timepoint [1] 334659 0
Assessed at baseline and approximately 9 months after baseline data collection
Secondary outcome [1] 421568 0
Sustainability, defined as continued use of the lunchbox nutrition program (SWAP IT) at 18 months, will be assessed via electronic registration records captured automatically following school registration to SWAP IT.?
Timepoint [1] 421568 0
Assessed at approximately 18 months after baseline data collection
Secondary outcome [2] 421569 0
Cost efficiency and affordability of the scale-up intervention (composite measure) will be assessed using cost-consequence analysis and budget impact via internal study records kept by the research team, conducted from the perspective of the government.
Timepoint [2] 421569 0
Assessed at approximately 9 months after baseline data collection
Secondary outcome [3] 421570 0
Mechanisms of action, defined as the theoretical mechanisms that may influence the effectiveness of the scale-up strategies within the intervention, will be assessed via an online or telephone survey with school principals allocated to the intervention and control group. The survey will include validated survey items to assess constructs targeted by the scale-up strategies, including perceived behavioural control, behavioural intentions, self-efficacy, subjective norms, attitudes, perceived usefulness, organisational readiness to change and school climate.
Timepoint [3] 421570 0
Assessed at baseline and approximately 9 months after baseline data collection

Eligibility
Key inclusion criteria
Primary and combined schools who cater for primary school aged children that are current users of the Audiri school-parent communication platform and who reside within the three Australian states (Victoria, Queensland South Australia) will be eligible. Schools who have not implemented the lunchbox nutrition program in the past two years will be eligible to participate.

Schools catering exclusively for children requiring specialist care, for example schools catering for severely disabled students will be excluded.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Schools with secondary students only, schools catering exclusively for children requiring specialist care, schools who have already implemented the lunchbox nutrition program will be ineligible to participate.

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)
Primary schools that are located within the following three states (VIC, QLD, SA) and have not previously implemented the lunchbox nutrition program will serve as the study sample. Following completion of baseline data collection and prior to delivery of the first intervention strategy, schools will be randomly allocated by an independent statistician to either the intervention or control condition.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Prior to delivery of the first intervention strategy, an independent statistician will randomise schools, using a computerised random number function, stratified by 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.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Descriptive statistics will be used to describe school characteristics, adoption of the nutrition program, intervention fidelity, acceptability and engagement with the dissemination strategies, intentions, barriers and enablers to adoption and the mechanism by which dissemination strategies may impede or facilitate implementation.



Analyses of trial outcomes will be undertaken under an intention to treat framework. For assessment of school level program adoption, the primary trial outcome between group differences will be assessed using logistic regression. The model will include a term for treatment group (intervention vs control) and pre-specified covariates prognostic of the outcome. Little, if any, missing primary outcome data is anticipated at follow-up, as program adoption is recorded automatically for all participating schools. Nonetheless, we will employ multiple imputation for any missing data in the event that schools withdraw from the study and request that their data is not used. All statistical tests will be 2 tailed with alpha of 0.05.

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
30/05/2023
Actual
30/05/2023
Date of last participant enrolment
Anticipated
30/08/2023
Actual
30/11/2023
Date of last data collection
Anticipated
31/12/2025
Actual
Sample size
Target
450
Accrual to date
Final
450
Recruitment in Australia
Recruitment state(s)
QLD,SA,VIC

Funding & Sponsors
Funding source category [1] 313778 0
Government body
Name [1] 313778 0
Australian Government, Medical Research Future Fund (MRFF)
Country [1] 313778 0
Australia
Primary sponsor type
University
Name
University of Newcastle
Address
University Drive
Callaghan NSW 2308
Country
Australia
Secondary sponsor category [1] 315610 0
Government body
Name [1] 315610 0
Hunter New England Population Health
Address [1] 315610 0
Locked Bag 10
Wallsend NSW 2287
Country [1] 315610 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 312948 0
Hunter New England Human Research Ethics Committee
Ethics committee address [1] 312948 0
Ethics committee country [1] 312948 0
Australia
Date submitted for ethics approval [1] 312948 0
15/02/2023
Approval date [1] 312948 0
28/03/2023
Ethics approval number [1] 312948 0
06/07/26/4.04

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

Contacts
Principal investigator
Name 126442 0
Dr Rachel Sutherland
Address 126442 0
Hunter New England Population Health
Locked Bag 10
Wallsend, NSW Australia 2287
Country 126442 0
Australia
Phone 126442 0
+61249246499
Fax 126442 0
Email 126442 0
[email protected]
Contact person for public queries
Name 126443 0
Rachel Sutherland
Address 126443 0
Hunter New England Population Health
Locked Bag 10
Wallsend, NSW Australia 2287
Country 126443 0
Australia
Phone 126443 0
+61249246499
Fax 126443 0
Email 126443 0
[email protected]
Contact person for scientific queries
Name 126444 0
Rachel Sutherland
Address 126444 0
Hunter New England Population Health
Locked Bag 10
Wallsend, NSW Australia 2287
Country 126444 0
Australia
Phone 126444 0
+61249246499
Fax 126444 0
Email 126444 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


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.