Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12623000558628
Ethics application status
Approved
Date submitted
8/05/2023
Date registered
24/05/2023
Date last updated
4/09/2023
Date data sharing statement initially provided
24/05/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
Evaluating the effectiveness of scale up strategies tailored to local context on the adoption of a text message based lunchbox program to address poor dietary intake in primary school aged children
Scientific title
A platform trial to evaluate strategies to maximise the adoption of a healthy lunchbox initiative: a solution to address poor dietary intake in primary school aged children
Secondary ID [1] 309599 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Obesity 329912 0
Condition category
Condition code
Public Health 326821 326821 0 0
Health promotion/education
Diet and Nutrition 326822 326822 0 0
Obesity

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
A modified platform trial design will be used to test the effectiveness of a series of scale-up strategies that have been tailored to context to maximise the adoption of an effective healthy lunchbox program within NSW primary schools located within 10 Local Health Districts 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 parent booklets, have been specifically developed for the SWAP IT program and are freely available to schools and parents.

A number of evidence-based scale-up strategies have been developed to support schools in the 10 LHDs to register for (i.e. adopt) SWAP IT. In order to ensure the strategies are appropriate for the context of each LHD, health promotion staff within each LHD selected strategies that would be delivered to schools in their region over a 9-month period. As a result, each LHD has selected a different combination of scale up strategies to be delivered to schools in their region. Within the 9-month intervention period, schools allocated to the intervention group within each LHD will receive a combination of the following strategies:

1. Sector Support and Endorsement: Policy makers from Education and Health will target principals, to communicate via up to three targeted letters (developed by the research team, approved and endorsed by the local opinion leaders), 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. As an additional strategy, some LHDs (outlined below) will use their existing connections to obtain endorsement for the program from local educational and wellbeing liaisons within the NSW Department of Education. This endorsement will be promoted to schools for an email distributed by the liaisons.

2. Local facilitation: 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 two existing school contacts, telephone calls or face-to-face visits, to assess interest in the program, address any barriers to adoption, and facilitate goal setting and action planning. Scripts developed by the research team to guide the local facilitation will incorporate motivational interviewing techniques to be employed by health promotion staff to address school barriers to adoption.

3. Develop and distribute educational materials: Targeted at principals 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 three contacts, including a printed information pack (consisting of a flyer, SWAP IT pen and booklet) and two emails to promote the program. As an additional strategy, one LHD will provide parent booklets promoting the SWAP IT program to all parents with children commencing the following school year within their school kindergarten orientation packs.

4. Local opinion leaders: Promotional materials, including one printed information pack (consisting of a flyer and SWAP IT parent booklet) and one email, will be delivered to other school decision makers, specifically the school administration manager and parent committee to promote the SWAP IT program and encourage schools to register.

5. Audit and feedback: Data and feedback on adoption of SWAP IT will be automatically captured via electronic registration records and 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.

6. Educational meeting: 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 conduct a webinar with schools to assess interest in the program, address any barriers to adoption. Webinar content will be developed by the research team in collaboration with health promotion staff.

An outline of the strategies employed by each LHD is provided below:

LHD 1: Sector support and endorsement; educational meeting; local facilitation; develop and distribute educational materials; local opinion leaders; audit and feedback.
LHD 2: Sector support and endorsement; educational meeting; local facilitation; develop and distribute educational materials; audit and feedback; local opinion leaders; additional endorsement strategy.
LHD 3: Sector support and endorsement; educational meeting; local facilitation; develop and distribute educational materials; local opinion leaders; audit and feedback.
LHD 4: Sector support and endorsement; educational meeting; develop and distribute educational materials; local opinion leaders; audit and feedback; additional endorsement strategy.
LHD 5: Sector support and endorsement; educational meeting; develop and distribute educational materials; local opinion leaders; audit and feedback.
LHD 6: Sector support and endorsement; educational meeting; develop and distribute educational materials; local opinion leaders; audit and feedback.
LHD 7: Sector support and endorsement; educational meeting; develop and distribute educational materials (printed information pack only, no emails); local opinion leaders; audit and feedback.
LHD 8: Sector support and endorsement; educational meeting; local facilitation; audit and feedback; additional educational materials strategy.
LHD 9: Sector support and endorsement (one letter only); educational meeting; local facilitation; develop and distribute educational materials; additional endorsement strategy.
LHD 10: Local facilitation; audit and feedback.
Intervention code [1] 326023 0
Behaviour
Comparator / control treatment
Schools allocated to the control group within each LHD will receive a different combination of the scale up strategies described above. Within each LHD, the combination of strategies differs for the intervention versus control schools. An outline of the strategies provided to control schools in each of the LHDs is provided below:
LHD 1: Sector support and endorsement; local opinion leaders
LHD 2: Local opinion leaders
LHD 3: No strategies (control schools will be offered the scale up strategies following the final data collection period, i.e. 9-months following the intervention period)
LHD 4: Audit and feedback; sector support and endorsement; educational materials
LHD 5: Audit and feedback; sector support and endorsement; educational materials; local opinion leaders
LHD 6: Audit and feedback; sector support and endorsement; local opinion leaders
LHD 7: No strategies (control schools will be offered the scale up strategies following the final data collection period, i.e. 9-months following the intervention period)
LHD 8: Educational materials
LHD 9: No strategies (control schools will be offered the scale up strategies following the final data collection period, i.e. 9-months following the intervention period)
LHD 10: No strategies (control schools will be offered the scale up strategies following the final data collection period, i.e. 9-months following the intervention period)
Control group
Active

Outcomes
Primary outcome [1] 334664 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] 334664 0
Assessed at baseline and approximately 9 months after baseline data collection
Secondary outcome [1] 421616 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] 421616 0
Assessed at approximately 18 months after baseline data collection
Secondary outcome [2] 421617 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] 421617 0
Assessed at approximately 9 months after baseline data collection

Eligibility
Key inclusion criteria
Department of Education (DoE), Catholic and Independent primary schools located within 10 LHDs of NSW (Murrumbidgee, Hunter New England, Sydney, Western Sydney, South Western Sydney, South Eastern Sydney, Northern Sydney, 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 do not use the Audiri parent communication app will be eligible, as these schools are participating in another trial (ACTRN12623000145606).
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 10 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 within each LHD, using a computerised random number function, stratified by school size 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
Statistical methods / analysis
Descriptive statistics will be used to describe adoption of the healthy lunchbox program. 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
30/07/2023
Actual
30/07/2023
Date of last data collection
Anticipated
30/03/2024
Actual
Sample size
Target
1341
Accrual to date
Final
1341
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 313781 0
University
Name [1] 313781 0
University of Newcastle
Country [1] 313781 0
Australia
Primary sponsor type
University
Name
University of Newcastle
Address
University Drive
Callaghan NSW 2308
Country
Australia
Secondary sponsor category [1] 315615 0
Government body
Name [1] 315615 0
Hunter New England Population Health
Address [1] 315615 0
Locked Bag 10
Wallsend NSW 2287
Country [1] 315615 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 312950 0
Hunter New England Human Research Ethics Committee
Ethics committee address [1] 312950 0
Ethics committee country [1] 312950 0
Australia
Date submitted for ethics approval [1] 312950 0
30/06/2022
Approval date [1] 312950 0
07/07/2022
Ethics approval number [1] 312950 0
06/07/26/4.04

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

Contacts
Principal investigator
Name 126450 0
Dr Rachel Sutherland
Address 126450 0
Hunter New England Population Health
Locked Bag 10
Wallsend, NSW Australia 2287
Country 126450 0
Australia
Phone 126450 0
+61249246499
Fax 126450 0
Email 126450 0
[email protected]
Contact person for public queries
Name 126451 0
Rachel Sutherland
Address 126451 0
Hunter New England Population Health
Locked Bag 10
Wallsend, NSW Australia 2287
Country 126451 0
Australia
Phone 126451 0
+61249246499
Fax 126451 0
Email 126451 0
[email protected]
Contact person for scientific queries
Name 126452 0
Rachel Sutherland
Address 126452 0
Hunter New England Population Health
Locked Bag 10
Wallsend, NSW Australia 2287
Country 126452 0
Australia
Phone 126452 0
+61249246499
Fax 126452 0
Email 126452 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.