Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12620001284954
Ethics application status
Approved
Date submitted
28/09/2020
Date registered
27/11/2020
Date last updated
27/11/2020
Date data sharing statement initially provided
27/11/2020
Type of registration
Retrospectively registered

Titles & IDs
Public title
The effectiveness of online menu labelling and audit and feedback in encouraging healthier food choices: a cluster randomised trial in NSW primary school canteens
Scientific title
The effectiveness of online menu labelling and audit and feedback in encouraging healthier food choices: a cluster randomised trial in NSW primary school canteens
Secondary ID [1] 302039 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record
ACTRN12619001150134 (this record is a sub-study of this study).

Health condition
Health condition(s) or problem(s) studied:
Poor diet 318620 0
obesity 318621 0
Condition category
Condition code
Public Health 316638 316638 0 0
Health promotion/education
Diet and Nutrition 316639 316639 0 0
Obesity

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Intervention components:
i) Strategy 1- Audit and feedback report: Canteen menus were audited against the NSW Healthy School Canteen Strategy – Food and Drink criteria, and a feedback report was provided to canteen managers and school principals. The 4-6 page report contained the school canteen’s menu classified against the Food and Drink Criteria and provided tailored suggestions for suitable product alternatives.
ii) Strategy 2- Online menu labels: Labels were added to online canteen menus. Each menu items was labelled as "Everyday", "Occasional", or "Caution" consistent with NSW Healthy School Canteen Strategy- Food and Drink criteria.
Mode of delivery:
i) Strategy 1- Audit and feedback report: Canteen menu audit and feedback reports were emailed to canteen managers and principals at intervention schools.
ii) Strategy 2- Online menu labels: All users of an online canteen ordering system at participating intervention schools were exposed to the labelling intervention. The intervention was integrated into the school's existing online canteen ordering system. Online canteen ordering systems allows users to view, select and pay for food and drink menu items, which are processed by the canteen and supplied to students during the lunch break. A small symbol appeared next to each menu item; a green circle for “Everyday” foods; a grey circle for “Occasional” foods; and a red warning sign (exclamation mark in a triangle) for “Caution” foods.
Intervention delivery personnel:
i) Strategy 1- Audit and feedback report: Research dietitians assessed the canteen menu against the Food and Drink Criteria, generated the feedback report (using a standardised template) and then emailed the report to the school. The research team also delivered verbal feedback to canteen staff via telephone (approx 30 min duration).
ii) Strategy 2- Online menu labels: Staff from the online canteen provider (Flexischools) modified the display of the online ordering system, so that each menu item was labelled as ‘Everyday’, ‘Occasional’, or ‘Caution’. At the commencement of strategy 2, a research assistant monitored the application of the online menu labels by checking the Flexischool system.
Intervention delivery schedule:
All intervention schools underwent a baseline data collection period of approximately 3 weeks.
Immediately following the baseline period, intervention schools were emailed the menu audit and feedback report from the research team and received a phone call (approx 30 min) from a research dietitian. No additional intervention strategy or support was offered from the project team for approximately 4 weeks (strategy 1).
Immediately following the 4 week period post report delivery (strategy 1), intervention schools had online canteen menu labelling switched on (strategy 2) for approximately 6 weeks. This 6 week period included an initial 2 week wash-in period, followed by a 4 week follow-up data collection period.
The study duration was 13 weeks in total, including a 3 week baseline period, 4 weeks of strategy 1, and 6 weeks of strategy 2.
Intervention code [1] 318334 0
Prevention
Intervention code [2] 318335 0
Behaviour
Comparator / control treatment
All control schools underwent a baseline period of approximately 3 weeks.
For the first 4 weeks following baseline data collection, control schools received no intervention (4 weeks of follow-up data collection occurred during this time).
Immediately following the 4 week non-intervention period, control schools were provided menu audit and feedback (strategy 1), no additional intervention strategy was delivered for 6 weeks, at which point the menu labels were applied (post-trial). This 6 week period included an initial 2 week wash-in period and 4 week follow-up data collection period.
The study duration was 13 weeks in total, including a 3 week baseline period, 4 weeks of no intervention, and 6 weeks of strategy 1.
Control group
Active

Outcomes
Primary outcome [1] 324763 0
The proportion of all online lunch order items sold that are 'Everyday', this data will be automatically recorded by the online ordering system.

Timepoint [1] 324763 0
Baseline data collection will take place over approximately 3 weeks. Follow-up data collection will take place over two discrete interventions periods of approximately 4 weeks each. This occurred during the 4 weeks immediately following the first introduction of strategy 1, and the 4 weeks immediately following a 2 week wash in period for strategy 2.


Primary outcome [2] 325544 0
The proportion of all online lunch order items sold that are ‘Occasional’, this data will be automatically recorded by the online ordering system.
Timepoint [2] 325544 0
Baseline data collection will take place over approximately 3 weeks. Follow-up data collection will take place over two discrete interventions periods of approximately 4 weeks each. This occurred during the 4 weeks immediately following the first introduction of strategy 1, and the 4 weeks immediately following a 2 week wash in period for strategy 2.
Primary outcome [3] 325545 0
The proportion of all online lunch order items sold that are 'Caution', this data will be automatically recorded by the online ordering system.
Timepoint [3] 325545 0
Baseline data collection will take place over approximately 3 weeks. Follow-up data collection will take place over two discrete interventions periods of approximately 4 weeks each. This occurred during the 4 weeks immediately following the first introduction of strategy 1, and the 4 weeks immediately following a 2 week wash in period for strategy 2.
Secondary outcome [1] 385703 0
The mean energy (kilojoule) content of student lunch orders, this data will be automatically recorded by the online ordering system.

Timepoint [1] 385703 0
Baseline data collection will take place over approximately 3 weeks. Follow-up data collection will take place over two discrete interventions periods of approximately 4 weeks each. This occurred during the 4 weeks immediately following the first introduction of strategy 1, and the 4 weeks immediately following a 2 week wash in period for strategy 2.

Secondary outcome [2] 388353 0
The mean saturated fat (grams) content of student lunch orders, this data will be automatically recorded by the online ordering system.
Timepoint [2] 388353 0
Baseline data collection will take place over approximately 3 weeks. Follow-up data collection will take place over two discrete interventions periods of approximately 4 weeks each. This occurred during the 4 weeks immediately following the first introduction of strategy 1, and the 4 weeks immediately following a 2 week wash in period for strategy 2.
Secondary outcome [3] 388354 0
The mean Sugar (grams) content of student lunch orders, this data will be automatically recorded by the online ordering system.
Timepoint [3] 388354 0
Baseline data collection will take place over approximately 3 weeks. Follow-up data collection will take place over two discrete interventions periods of approximately 4 weeks each. This occurred during the 4 weeks immediately following the first introduction of strategy 1, and the 4 weeks immediately following a 2 week wash in period for strategy 2.
Secondary outcome [4] 388355 0
The mean sodium (mg) content of student lunch orders, this data will be automatically recorded by the online ordering system.
Timepoint [4] 388355 0
Baseline data collection will take place over approximately 3 weeks. Follow-up data collection will take place over two discrete interventions periods of approximately 4 weeks each. This occurred during the 4 weeks immediately following the first introduction of strategy 1, and the 4 weeks immediately following a 2 week wash in period for strategy 2.
Secondary outcome [5] 388356 0
Average daily revenue from online orders, this data will be automatically recorded by the online ordering system.
Timepoint [5] 388356 0
Baseline data collection will take place over approximately 3 weeks. Follow-up data collection will take place over two discrete interventions periods of approximately 4 weeks each. This occurred during the 4 weeks immediately following the first introduction of strategy 1, and the 4 weeks immediately following a 2 week wash in period for strategy 2.

Eligibility
Key inclusion criteria
1. NSW Government primary schools which are currently using an online canteen ordering system provided by Flexischools
2. All primary school students who have at least one online lunch order placed during the data collection periods within participating schools will be included
Minimum age
5 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
1. Externally licensed school canteens, with private operators servicing multiple schools were excluded.
2. Combined primary and secondary schools, with a combined canteen menu.
4. Special purpose schools catering for students with special needs (e.g. juvenile justice or schools serving hospitalised children) were excluded.

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)
Allocation is not concealed
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
1:1 ratio by computer program conducted by an independent statistician
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
N/A
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
23/10/2018
Date of last participant enrolment
Anticipated
Actual
10/12/2018
Date of last data collection
Anticipated
Actual
31/05/2019
Sample size
Target
1940
Accrual to date
Final
2000
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 306458 0
Government body
Name [1] 306458 0
National Health and Medical Research Council (NHMRC)
Country [1] 306458 0
Australia
Funding source category [2] 306462 0
Charities/Societies/Foundations
Name [2] 306462 0
Newcastle Permanent Charitable Foundation
Country [2] 306462 0
Australia
Funding source category [3] 306463 0
Other Collaborative groups
Name [3] 306463 0
Hunter Medical Research Institute
Country [3] 306463 0
Australia
Primary sponsor type
Individual
Name
Dr Rebecca Wyse
Address
The University of Newcastle, Australia
1 University Dr, Callaghan NSW 2308
Country
Australia
Secondary sponsor category [1] 306982 0
None
Name [1] 306982 0
Address [1] 306982 0
Country [1] 306982 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 306665 0
The University of Newcastle Human Research Ethics Committee (HREC)
Ethics committee address [1] 306665 0
Ethics committee country [1] 306665 0
Australia
Date submitted for ethics approval [1] 306665 0
16/11/2017
Approval date [1] 306665 0
22/03/2018
Ethics approval number [1] 306665 0
H-2017-0402
Ethics committee name [2] 306840 0
State Education Research Approval Process (SERAP)
Ethics committee address [2] 306840 0
Ethics committee country [2] 306840 0
Australia
Date submitted for ethics approval [2] 306840 0
13/03/2018
Approval date [2] 306840 0
12/09/2018
Ethics approval number [2] 306840 0
2018065

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

Contacts
Principal investigator
Name 104610 0
Dr Rebecca Wyse
Address 104610 0
Hunter New England Population Health,
Locked Bag 10
Wallsend, NSW
2287
Country 104610 0
Australia
Phone 104610 0
+61 2 4924 6310
Fax 104610 0
Email 104610 0
[email protected]
Contact person for public queries
Name 104611 0
Rebecca Wyse
Address 104611 0
Hunter New England Population Health,
Locked Bag 10
Wallsend, NSW
2287
Country 104611 0
Australia
Phone 104611 0
+61 2 4924 6310
Fax 104611 0
Email 104611 0
[email protected]
Contact person for scientific queries
Name 104612 0
Rebecca Wyse
Address 104612 0
Hunter New England Population Health,
Locked Bag 10
Wallsend, NSW
2287
Country 104612 0
Australia
Phone 104612 0
+61 2 4924 6310
Fax 104612 0
Email 104612 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.