Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622000406707
Ethics application status
Approved
Date submitted
4/03/2022
Date registered
9/03/2022
Date last updated
9/03/2022
Date data sharing statement initially provided
9/03/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
Evaluating the efficacy of a multi-component dissemination strategy on the adoption of a school-based lunchbox nutrition program on the NSW Mid North Coast Local Health District of New South Wales
Scientific title
Evaluating the efficacy of a multi-component dissemination strategy on the adoption of a school-based lunchbox nutrition program on the NSW Mid North Coast Local Health District of New South Wales
Secondary ID [1] 306601 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 Mid North Coast Local Health District.

Health condition
Health condition(s) or problem(s) studied:
Obesity 325510 0
Condition category
Condition code
Diet and Nutrition 322886 322886 0 0
Obesity
Public Health 322887 322887 0 0
Health promotion/education

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 Mid North Coast 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 four 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. A program invitation will be disseminated to schools via an eNewsletter targeting school principals and teachers, which will provide an overview of SWAP IT and encourage schools to adopt the program via an online portal. Schools will be provided with access to the online portal, which will 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. Following the initial program invitation, a comprehensive communication strategy, consisting of emails (up to two) with embedded videos, will be disseminated to schools to increase school principal motivation to adopt the SWAP IT program. The emails will be delivered in a staggered approach (i.e. sent approximately 4-5 weeks apart) throughout the intervention period and will consist of educational and motivational videos addressing theoretically identified barriers to nutrition program adoption. The emails will take approximately two minutes to read and target school principals or key contacts. Each video is less than one minute duration and focusses on a key barrier to the adoption of SWAP IT. If a school registers for the program, they will not receive further communication encouraging adoption.

The number of emails sent and received, and video views will be used to monitor the implementation of the intervention.
Intervention code [1] 323030 0
Behaviour
Comparator / control treatment
At the commencement of the study, a program invitation will be disseminated to schools allocated to the control group via an eNewsletter, which will provide an overview of SWAP IT and encourage schools to adopt the program via the online portal.
Control group
Active

Outcomes
Primary outcome [1] 330667 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] 330667 0
Assessed at approximately 6 months after the initial invitation distributed to schools.
Secondary outcome [1] 407125 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 purpose-designed for this study by the research team with principals or key contacts.
Timepoint [1] 407125 0
Assessed at approximately 6 months after the initial invitation distributed to schools.
Secondary outcome [2] 407126 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] 407126 0
Assessed at approximately 6 months after the initial invitation distributed to schools.
Secondary outcome [3] 407127 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] 407127 0
Assessed at approximately 6 months after the initial invitation distributed to schools.

Eligibility
Key inclusion criteria
Department of Education (DoE) and Independent schools located within the Mid North Coast 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 Mid North Coast Local Health District and have not previously implemented the lunchbox nutrition program will serve as the study sample. Prior 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).
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 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 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
1/04/2022
Actual
Date of last participant enrolment
Anticipated
30/08/2022
Actual
Date of last data collection
Anticipated
30/11/2022
Actual
Sample size
Target
60
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment postcode(s) [1] 36944 0
2429 - Wingham
Recruitment postcode(s) [2] 36945 0
2431 - South West Rocks
Recruitment postcode(s) [3] 36946 0
2439 - Lorne
Recruitment postcode(s) [4] 36947 0
2440 - Kempsey
Recruitment postcode(s) [5] 36948 0
2441 - Telegraph Point
Recruitment postcode(s) [6] 36949 0
2443 - Laurieton
Recruitment postcode(s) [7] 36950 0
2444 - Port Macquarie
Recruitment postcode(s) [8] 36951 0
2445 - Lake Cathie
Recruitment postcode(s) [9] 36952 0
2446 - Wauchope
Recruitment postcode(s) [10] 36953 0
2447 - Scotts Head
Recruitment postcode(s) [11] 36954 0
2448 - Nambucca Heads
Recruitment postcode(s) [12] 36955 0
2449 - Bowraville
Recruitment postcode(s) [13] 36956 0
2450 - Coffs Harbour
Recruitment postcode(s) [14] 36957 0
2452 - Sawtell
Recruitment postcode(s) [15] 36958 0
2453 - Dorrigo
Recruitment postcode(s) [16] 36960 0
2454 - Bellingen
Recruitment postcode(s) [17] 36961 0
2455 - Urunga
Recruitment postcode(s) [18] 36962 0
2456 - Woolgoolga

Funding & Sponsors
Funding source category [1] 310939 0
Government body
Name [1] 310939 0
Hunter New England Population Health
Country [1] 310939 0
Australia
Primary sponsor type
University
Name
The University of Newcastle
Address
University Drive
Callaghan NSW 2308
Country
Australia
Secondary sponsor category [1] 312231 0
Government body
Name [1] 312231 0
Hunter New England Population Health
Address [1] 312231 0
Locked Bag 10
Wallsend NSW 2287
Country [1] 312231 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 310492 0
Hunter New England Human Research Ethics Committee
Ethics committee address [1] 310492 0
Locked Bag 1, New Lambton NSW 2305
Ethics committee country [1] 310492 0
Australia
Date submitted for ethics approval [1] 310492 0
21/10/2021
Approval date [1] 310492 0
26/10/2021
Ethics approval number [1] 310492 0
06/07/26/4.04

Summary
Brief summary
The aim of this randomised controlled trial is to increase adoption of the lunchbox nutrition program ‘SWAP IT ’ in primary schools located in the Mid North Coast Local Health District. This trial will evaluate whether a theory-based multi-component dissemination strategy targeting barriers to adoption can improve the adoption rates of the nutrition program. Schools will be randomly allocated to receive either a multi-component dissemination strategy over a four month period, or a minimal intervention control group. Intervention effectiveness will be determined by comparing, relative to control, the absolute difference in the proportion of schools adopting the program at 6-month follow up. The trial aims to generate evidence regarding the effectiveness of strategies to inform broader dissemination of the lunchbox nutrition program.
Trial website
Trial related presentations / publications
Public notes
This study is being conducted as part of usual service delivery by the Mid North Coast Local Health District in the context of a jurisdiction wide roll out.

This trial is being conducted as part of a series of studies conducted to examine the effectiveness of multi-component dissemination strategies to improve adoption of a school-based nutrition program across multiple Local Health Districts in New South Wales (Hunter New England: ACTRN12622000252718; Central Coast: ACTRN12622000257763). Previous research has been conducted examining this school-based program: 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.

Contacts
Principal investigator
Name 117862 0
Dr Courtney Barnes
Address 117862 0
Hunter New England Population Health
Locked Bag 10
Wallsend, NSW Australia 2287
Country 117862 0
Australia
Phone 117862 0
+61 2 49246678
Fax 117862 0
+61 2 4924 6490
Email 117862 0
Courtney.Barnes@health.nsw.gov.au
Contact person for public queries
Name 117863 0
Dr Courtney Barnes
Address 117863 0
Hunter New England Population Health
Locked Bag 10
Wallsend, NSW Australia 2287
Country 117863 0
Australia
Phone 117863 0
+61 2 49246678
Fax 117863 0
+61 2 4924 6490
Email 117863 0
Courtney.Barnes@health.nsw.gov.au
Contact person for scientific queries
Name 117864 0
Dr Courtney Barnes
Address 117864 0
Hunter New England Population Health
Locked Bag 10
Wallsend, NSW Australia 2287
Country 117864 0
Australia
Phone 117864 0
+61 2 49246678
Fax 117864 0
+61 2 4924 6490
Email 117864 0
Courtney.Barnes@health.nsw.gov.au

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.


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.