Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12623000145606
Ethics application status
Approved
Date submitted
13/01/2023
Date registered
13/02/2023
Date last updated
20/05/2024
Date data sharing statement initially provided
13/02/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
An evaluation into the state-wide scale up of a text message based healthy lunchbox program aimed at improving child nutrition
Scientific title
A randomised controlled trial to evaluate the scale-up of a technology based healthy lunchbox initiative: a solution to address poor dietary intake in primary school aged children
Secondary ID [1] 308844 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Obesity 328683 0
Condition category
Condition code
Public Health 325692 325692 0 0
Health promotion/education
Diet and Nutrition 325693 325693 0 0
Obesity

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
A 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 within NSW primary schools located within 11 Local Health Districts (LHDs) of NSW.

The effective healthy lunchbox program (‘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 parents booklets, have been specifically developed for the SWAP IT program and are freely available to schools and parents.

Schools allocated to the intervention group will receive a theoretically-based multi-component dissemination intervention to support schools to register for SWAP IT. The intervention will be delivered over a period of 9 months. The scale up strategy will consist of the following evidence-based components:

Program integration: SWAP IT will be integrated into the school communication platform (SkoolBag) interface routinely used by, and familiar to schools. Specifically, principals will be alerted to program availability via up to four SkoolBag 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.

Endorsement from health and education stakeholders: Policy makers from Education and Health 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.

Local opinion leaders: Health promotion staff from LHDs 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.

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; 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).

Monitoring and feedback: Data from SkoolBag will be used to monitor adoption, provide feedback to schools via the communication strategy and help guide execution and targeting of components.

Intervention code [1] 325203 0
Behaviour
Comparator / control treatment
The program will appear on the SkoolBag user dashboard of waitlist control schools only. No other prompts, alerts or actions by SkoolBag to encourage adoption will be undertaken until after the completion of follow-up data collection. The control group will be offered the intervention following the final data collection period (i.e. 9-months following the intervention period).
Control group
Active

Outcomes
Primary outcome [1] 333545 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] 333545 0
Assessed at baseline and approximately 9 months after baseline data collection
Secondary outcome [1] 417485 0
Cost efficiency and affordability of the scale-up intervention 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 NSW government.
Timepoint [1] 417485 0
Assessed at approximately 9 months after baseline data collection
Secondary outcome [2] 417486 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, conducted by a trained researcher. The survey will include validated survey items (Venkatesh et al, 2008, Dearing et al, 2018) to assess constructs targeted by the scale-up strategies as a composite outcome, including perceived behavioural control, behavioural intentions, self-efficacy, subjective norms, attitudes, perceived usefulness, organisational readiness to change and school climate.
Timepoint [2] 417486 0
Assessed at baseline and approximately 9 months after baseline data collection

Eligibility
Key inclusion criteria
Department of Education (DoE), and Independent primary schools located within 11 LHDs of NSW (Murrumbidgee, Hunter New England, Sydney, Western Sydney, South Western Sydney, South Eastern Sydney, Northern Sydney, Southern NSW, Western NSW, Nepean Blue Mountains, Illawarra Shoalhaven).

Primary and combined schools who cater for primary school aged children will be invited to participate. Schools who have not implemented the lunchbox nutrition program will be eligible to participate. Schools that use the SkoolBag parent communication app will be eligible.
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 11 LHDs of NSW and have not previously implemented the lunchbox nutrition program with 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 not otherwise involved in the trial 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 using random block sizes of between 2-6.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



The people analysing the results/data
Intervention assignment
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 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
14/02/2023
Actual
14/02/2023
Date of last participant enrolment
Anticipated
30/03/2023
Actual
30/03/2023
Date of last data collection
Anticipated
31/12/2025
Actual
Sample size
Target
344
Accrual to date
Final
344
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 312963 0
Government body
Name [1] 312963 0
New South Wales Ministry of Health, Translational Research Grants Scheme
Country [1] 312963 0
Australia
Primary sponsor type
University
Name
University of Newcastle
Address
University Drive
Callaghan NSW 2308
Country
Australia
Secondary sponsor category [1] 314651 0
Government body
Name [1] 314651 0
Hunter New England Population Health
Address [1] 314651 0
Locked Bag 10
Wallsend NSW 2287
Country [1] 314651 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 312234 0
Hunter New England Human Research Ethics Committee
Ethics committee address [1] 312234 0
Ethics committee country [1] 312234 0
Australia
Date submitted for ethics approval [1] 312234 0
30/06/2022
Approval date [1] 312234 0
07/07/2022
Ethics approval number [1] 312234 0
06/07/26/4.04

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

Contacts
Principal investigator
Name 123934 0
Dr Rachel Sutherland
Address 123934 0
Hunter New England Population Health
Locked Bag 10
Wallsend, NSW Australia 2287
Country 123934 0
Australia
Phone 123934 0
+61 2 4924 6499
Fax 123934 0
Email 123934 0
[email protected]
Contact person for public queries
Name 123935 0
Rachel Sutherland
Address 123935 0
Hunter New England Population Health
Locked Bag 10
Wallsend, NSW Australia 2287
Country 123935 0
Australia
Phone 123935 0
+61 2 4924 6499
Fax 123935 0
Email 123935 0
[email protected]
Contact person for scientific queries
Name 123936 0
Rachel Sutherland
Address 123936 0
Hunter New England Population Health
Locked Bag 10
Wallsend, NSW Australia 2287
Country 123936 0
Australia
Phone 123936 0
+61 2 4924 6499
Fax 123936 0
Email 123936 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
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.