Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622000252718
Ethics application status
Approved
Date submitted
4/02/2022
Date registered
11/02/2022
Date last updated
11/02/2022
Date data sharing statement initially provided
11/02/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
Assessing the effectiveness of methods of inviting schools to implement a lunchbox nutrition program
Scientific title
A randomised controlled trial to test a theory-based multi-component dissemination strategy in inviting primary schools to implement a lunchbox nutrition program
Secondary ID [1] 306343 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record
Yes, registration record ACTRN12618001731280 describes an earlier effectiveness trial for this intervention conducted by the research team. The effectiveness trial has been conducted and results have been published. This current trial follows on from the effectiveness trial and will be conducted with schools located in the Hunter New England Local Health District.

Health condition
Health condition(s) or problem(s) studied:
Obesity 325140 0
Condition category
Condition code
Public Health 322545 322545 0 0
Health promotion/education
Diet and Nutrition 322546 322546 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 theory-based multi-component dissemination strategy to invite primary schools to implement a lunchbox nutrition program (‘SWAP IT’) among schools located in the Hunter New England Local Health District of New South Wales (NSW), Australia, that have not previously implemented the program.

SWAP IT consists of electronic messages sent to parents via usual parent communication channels (parent communication app, newsletter or Facebook), together with classroom resources, and parent booklets. 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. SWAP IT has previously been found to be effective at improving the packing of healthy lunchboxes and improving child dietary intake.

Primary schools that have not previously implemented the lunchbox nutrition program will be randomly allocated to one of two study groups: a multi-component intervention group or a minimal intervention control group. The intervention will be delivered over a period of 3-4 months.

Schools allocated to the intervention group will receive a theoretically-based multi-component dissemination intervention to support schools to register for and adopt the lunchbox nutrition program. Schools will be provided with access to an online portal, which is act as a central registration system for schools to register for SWAP IT directly, and access all program resources. The portal will also contain a technical assistance function where principals, school staff and parents can enquire about the SWAP IT program. A program invitation will be disseminated to schools via email addressed to school principals or key contacts, which will embed educational and motivational videos addressing theoretically identified barriers to nutrition program adoption. A comprehensive communication strategy will consist of emails with embedded videos, telephone, and online portal content designed to increase school principal motivation to adopt the SWAP IT program. The emails (up to three) and telephone support (one telephone call) will be delivered in a staggered approach throughout the intervention period. The emails will take approximately 2 minutes to read. Each video is less than 1 minute in duration and focusses on a key barrier to the adoption of SWAP IT. One email and video will be sent to intervention schools approximately every 2 to 3 weeks (up to 3 in total) and will target the school principal or key contact. If a school registers for the program, they will not receive further communication encouraging adoption. Targeted telephone calls to encourage program adoption will also be conducted by health promotion practitioners. The telephone calls will be undertaken approximately 2-3 weeks following the emails with school principals, school wellbeing coordinators or key contacts and will aim to overcome any barriers to adoption. The duration of the telephone call is anticipated to be 10-15 minutes. Schools that have not registered to implement SWAP IT will receive feedback regarding program adoption through the emails and telephone call delivered to schools as part of the communication and marketing strategy. The feedback will specify the number of schools that have adopted the SWAP IT program.

The number of emails sent and received, and video views will be used to monitor the implementation of the intervention. Telephone call date of completion and call duration will be recorded in a study monitoring spreadsheet.
Intervention code [1] 322775 0
Behaviour
Comparator / control treatment
At the commencement of the study, schools allocated to the control group will receive an email invitation to register for the lunchbox nutrition program, with a link to the online portal to register for the program.

All schools, including those allocated to the control group, will receive the SWAP IT program after they register via the online portal. Only schools allocated to the intervention group will receive the multi-component dissemination intervention.
Control group
Active

Outcomes
Primary outcome [1] 330341 0
Adoption will be defined as the number of schools who agree to implement the lunchbox nutrition program (SWAP IT). This will be assessed within schools allocated to the intervention and control group via registrations received from the online portal.
Timepoint [1] 330341 0
Assessed at approximately 6 months after the initial invitation distributed to schools.
Secondary outcome [1] 405879 0
Implementation will be defined as the proportion of schools that implement each component of SWAP IT at 6 months, including the messages, lunchbox nutrition guidelines, school and parent resources. Implementation will be assessed via an online survey will principals or key contacts.
The online survey has been purpose-designed for this study by the research team.
Timepoint [1] 405879 0
Assessed at approximately 6 months after the initial invitation distributed to schools.
Secondary outcome [2] 405880 0
Maintenance of the SWAP IT program will be defined as: (i) number of schools who continue to implement the SWAP IT program after the 6 month intervention period; and (ii) the number of schools who opt out of delivering SWAP IT. Maintenance of the SWAP IT program within schools allocated to the intervention and control group will be assessed through the online portal.
Timepoint [2] 405880 0
Assessed at approximately 6 months after the initial invitation distributed to schools.
Secondary outcome [3] 405881 0
Cost for health promotion staff to deliver the dissemination strategies, including the development and delivery of each strategy to schools allocated to the intervention and control group, will be assessed via internal study records kept by the research team.
Timepoint [3] 405881 0
Assessed at approximately 6 months after the initial invitation distributed to schools.


Eligibility
Key inclusion criteria
Department of Education (DoE), Catholic and Independent schools located within the Hunter New England Local Health District, 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. Schools that use an alternative app, Facebook, or other method to communicate with parents will also 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 Hunter New England Local Health District and have not previously implemented the lunchbox nutrition program with serve as the study sample. Prior to invitation to delivery of the first intervention strategy schools will be randomly allocated to either the intervention or control condition. Following the intervention, school principals in both conditions will be sent a study information statement and invitation to participate in the data collection component of the study (i.e. the follow up survey).

Schools will be randomised by an independent statistician not otherwise involved in the trial, using a computerised random number function. Schools will not be notified of the allocation, however the health promotion officers delivering the intervention will be aware of group allocations.
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
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. First, we will include all schools in the analysis. We will then look at schools that had the SkoolBag parent communication app at the beginning of the study. 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 by the online portal. 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
Not yet recruiting
Date of first participant enrolment
Anticipated
1/03/2022
Actual
Date of last participant enrolment
Anticipated
30/07/2022
Actual
Date of last data collection
Anticipated
31/10/2022
Actual
Sample size
Target
235
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment postcode(s) [1] 36577 0
2259 - Wyee
Recruitment postcode(s) [2] 36579 0
2264 - Morisset
Recruitment postcode(s) [3] 36580 0
2265 - Cooranbong
Recruitment postcode(s) [4] 36581 0
2278 - Barnsley
Recruitment postcode(s) [5] 36582 0
2280 - Belmont
Recruitment postcode(s) [6] 36583 0
2282 - Warners Bay
Recruitment postcode(s) [7] 36584 0
2283 - Fassifern
Recruitment postcode(s) [8] 36585 0
2284 - Boolaroo
Recruitment postcode(s) [9] 36586 0
2285 - Cardiff
Recruitment postcode(s) [10] 36587 0
2287 - Wallsend
Recruitment postcode(s) [11] 36588 0
2289 - Kotara South
Recruitment postcode(s) [12] 36589 0
2290 - Charlestown
Recruitment postcode(s) [13] 36590 0
2291 - Merewether
Recruitment postcode(s) [14] 36591 0
2294 - Carrington
Recruitment postcode(s) [15] 36592 0
2295 - Stockton
Recruitment postcode(s) [16] 36593 0
2296 - Islington
Recruitment postcode(s) [17] 36594 0
2298 - Waratah
Recruitment postcode(s) [18] 36595 0
2299 - Lambton
Recruitment postcode(s) [19] 36596 0
2300 - Newcastle
Recruitment postcode(s) [20] 36597 0
2304 - Mayfield
Recruitment postcode(s) [21] 36598 0
2305 - New Lambton
Recruitment postcode(s) [22] 36599 0
2306 - Windale
Recruitment postcode(s) [23] 36600 0
2311 - Gresford
Recruitment postcode(s) [24] 36601 0
2312 - Nabiac
Recruitment postcode(s) [25] 36602 0
2315 - Nelson Bay
Recruitment postcode(s) [26] 36603 0
2316 - Bobs Farm
Recruitment postcode(s) [27] 36604 0
2317 - Salamander Bay
Recruitment postcode(s) [28] 36605 0
2318 - Medowie
Recruitment postcode(s) [29] 36606 0
2319 - Tanilba Bay
Recruitment postcode(s) [30] 36607 0
2320 - Maitland
Recruitment postcode(s) [31] 36608 0
2321 - Clarence Town
Recruitment postcode(s) [32] 36609 0
2322 - Beresfield
Recruitment postcode(s) [33] 36610 0
2323 - Ashtonfield
Recruitment postcode(s) [34] 36611 0
2324 - Millers Forest
Recruitment postcode(s) [35] 36612 0
2325 - Cessnock
Recruitment postcode(s) [36] 36613 0
2326 - Abermain
Recruitment postcode(s) [37] 36614 0
2327 - Kurri Kurri
Recruitment postcode(s) [38] 36615 0
2328 - Denman
Recruitment postcode(s) [39] 36616 0
2329 - Merriwa
Recruitment postcode(s) [40] 36617 0
2330 - Singleton
Recruitment postcode(s) [41] 36618 0
2333 - Muswellbrook
Recruitment postcode(s) [42] 36619 0
2334 - Greta
Recruitment postcode(s) [43] 36620 0
2335 - Branxton
Recruitment postcode(s) [44] 36621 0
2336 - Aberdeen
Recruitment postcode(s) [45] 36622 0
2337 - Belltrees
Recruitment postcode(s) [46] 36623 0
2339 - Willow Tree
Recruitment postcode(s) [47] 36624 0
2340 - Tamworth
Recruitment postcode(s) [48] 36625 0
2342 - Currabubula
Recruitment postcode(s) [49] 36626 0
2343 - Quirindi
Recruitment postcode(s) [50] 36627 0
2344 - Duri
Recruitment postcode(s) [51] 36628 0
2345 - Attunga
Recruitment postcode(s) [52] 36629 0
2346 - Manilla
Recruitment postcode(s) [53] 36630 0
2347 - Barraba
Recruitment postcode(s) [54] 36631 0
2350 - Armidale
Recruitment postcode(s) [55] 36632 0
2352 - Kootingal
Recruitment postcode(s) [56] 36633 0
2353 - Moonbi
Recruitment postcode(s) [57] 36634 0
2354 - Walcha
Recruitment postcode(s) [58] 36635 0
2355 - Bendemeer
Recruitment postcode(s) [59] 36636 0
2358 - Uralla
Recruitment postcode(s) [60] 36637 0
2360 - Inverell
Recruitment postcode(s) [61] 36638 0
2361 - Ashford
Recruitment postcode(s) [62] 36639 0
2365 - Guyra
Recruitment postcode(s) [63] 36640 0
2369 - Tingha
Recruitment postcode(s) [64] 36641 0
2370 - Glen Innes
Recruitment postcode(s) [65] 36642 0
2371 - Deepwater
Recruitment postcode(s) [66] 36643 0
2372 - Tenterfield
Recruitment postcode(s) [67] 36644 0
2380 - Gunnedah
Recruitment postcode(s) [68] 36645 0
2381 - Curlewis
Recruitment postcode(s) [69] 36646 0
2382 - Boggabri
Recruitment postcode(s) [70] 36647 0
2386 - Burren Junction
Recruitment postcode(s) [71] 36648 0
2387 - Rowena
Recruitment postcode(s) [72] 36649 0
2388 - Pilliga
Recruitment postcode(s) [73] 36650 0
2390 - Narrabri
Recruitment postcode(s) [74] 36651 0
2399 - Pallamallawa
Recruitment postcode(s) [75] 36652 0
2400 - Moree
Recruitment postcode(s) [76] 36653 0
2401 - Gravesend
Recruitment postcode(s) [77] 36654 0
2402 - Warialda
Recruitment postcode(s) [78] 36655 0
2404 - Bingara
Recruitment postcode(s) [79] 36656 0
2405 - Garah
Recruitment postcode(s) [80] 36657 0
2406 - Mungindi
Recruitment postcode(s) [81] 36658 0
2409 - Boggabilla
Recruitment postcode(s) [82] 36659 0
2410 - Yetman
Recruitment postcode(s) [83] 36660 0
2420 - Martins Creek
Recruitment postcode(s) [84] 36661 0
2421 - Paterson
Recruitment postcode(s) [85] 36662 0
2422 - Gloucester
Recruitment postcode(s) [86] 36663 0
2423 - Bulahdelah
Recruitment postcode(s) [87] 36664 0
2424 - Mount George
Recruitment postcode(s) [88] 36665 0
2425 - Stroud
Recruitment postcode(s) [89] 36666 0
2426 - Coopernook
Recruitment postcode(s) [90] 36667 0
2428 - Forster
Recruitment postcode(s) [91] 36668 0
2429 - Wingham
Recruitment postcode(s) [92] 36669 0
2430 - Taree
Recruitment postcode(s) [93] 36670 0
2443 - Johns River
Recruitment postcode(s) [94] 36671 0
4383 - Jennings

Funding & Sponsors
Funding source category [1] 310700 0
Government body
Name [1] 310700 0
Hunter New England Population Health
Country [1] 310700 0
Australia
Primary sponsor type
University
Name
The University of Newcastle
Address
University Drive
Callaghan NSW 2308
Country
Australia
Secondary sponsor category [1] 311918 0
Government body
Name [1] 311918 0
Hunter New England Population Health
Address [1] 311918 0
Locked Bag 10
Wallsend NSW 2287
Country [1] 311918 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 310281 0
Hunter New England Human Research Ethics Committee
Ethics committee address [1] 310281 0
Ethics committee country [1] 310281 0
Australia
Date submitted for ethics approval [1] 310281 0
21/10/2021
Approval date [1] 310281 0
26/10/2021
Ethics approval number [1] 310281 0
06/07/26/4.04

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

Contacts
Principal investigator
Name 117110 0
Dr Jannah Jones
Address 117110 0
Hunter New England Population Health
Locked Bag 10
Wallsend, NSW Australia 2287
Country 117110 0
Australia
Phone 117110 0
+61 2 4924 6092
Fax 117110 0
+61 2 4924 6490
Email 117110 0
[email protected]
Contact person for public queries
Name 117111 0
Jannah Jones
Address 117111 0
Hunter New England Population Health
Locked Bag 10
Wallsend, NSW Australia 2287
Country 117111 0
Australia
Phone 117111 0
+61 2 4924 6092
Fax 117111 0
+61 2 4924 6490
Email 117111 0
[email protected]
Contact person for scientific queries
Name 117112 0
Jannah Jones
Address 117112 0
Hunter New England Population Health
Locked Bag 10
Wallsend, NSW Australia 2287
Country 117112 0
Australia
Phone 117112 0
+61 2 4924 6092
Fax 117112 0
+61 2 4924 6490
Email 117112 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
No individual participant data for this trial will be available as ethics approval does not cover this. If a request for individual participant data is made and appropriate ethics approvals obtained, such data may be made available in the future.


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.