Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12616001520426
Ethics application status
Approved
Date submitted
1/11/2016
Date registered
4/11/2016
Date last updated
26/11/2018
Date data sharing statement initially provided
26/11/2018
Date results provided
26/11/2018
Type of registration
Retrospectively registered

Titles & IDs
Public title
The effect of re-positioning fruit and vegetable items within an online menu on
the purchasing patterns of users of an online lunch ordering systems for primary school students.
Scientific title
The efficacy of re-positioning fruit and vegetable items within an online menu on the purchase of fruit and vegetable items, by users of an online lunch ordering system for primary school students: A cluster randomized controlled trial
Secondary ID [1] 290423 0
None
Universal Trial Number (UTN)
Nil
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Child Diet 300763 0
Poor fruit and vegetable intake 300824 0
Condition category
Condition code
Diet and Nutrition 300602 300602 0 0
Obesity
Public Health 300603 300603 0 0
Health promotion/education

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Eligible schools utilising an online lunch ordering system will be randomised to receive the following intervention to their online canteen menu. All fruit and vegetable items (i.e. fresh, frozen, tinned, dried) will be grouped together in a single category by a dietitian. The category will be listed multiple times within the online menu, and will be moved to more prominent positions within the menu i.e. the first and last category of foods displayed on the online menu. Intervention schools will be required to maintain these menu changes throughout the 4-week duration of the intervention.

Intervention Delivery and Duration: For schools allocated to receive the intervention, the re-designed menu will be uploaded at one time point and will remain in place for 4 weeks.

Intervention Fidelity: The provider of the online canteen service will send through a mid-intervention report listing any changes that have been made to the online menu since the launch of the intervention, in order to determine intervention fidelity. Any deviations from the original intervention positioning will be corrected.

Location: The online intervention will be delivered via the online lunch ordering system. Users of the system (primary school children and their parents) will access the online menu (to make their selection and pay) via their mobile devices (phone or tablet) or their computer.
Intervention code [1] 296255 0
Prevention
Intervention code [2] 296256 0
Behaviour
Intervention code [3] 296312 0
Lifestyle
Comparator / control treatment
Schools allocated to received the control will continue to utilize the online ordering system, and no changes will be made to the position of fruit or vegetable items within their online menu.
Control group
Active

Outcomes
Primary outcome [1] 300015 0
Primary Outcome: The proportion of online student lunch orders that contain a fruit or vegetable item. NB. Sales data are automatically recorded by the online ordering system.

Timepoint [1] 300015 0
Timepoint: Baseline – the 4-week period immediately preceding intervention commencement. Follow-up – the 4-week period post intervention commencement
Secondary outcome [1] 328806 0
Secondary Outcome: The proportion of all online lunch order items that are fruit or vegetable items. NB. Sales data are automatically recorded by the online ordering system.
Timepoint [1] 328806 0
Timepoint: Baseline – the 4-week period immediately preceding intervention commencement. Follow-up – the 4-week period post intervention commencement
Secondary outcome [2] 328807 0
Adverse outcome: Canteen revenue over the intervention period will be collected to determine if the intervention impacted overall online canteen sales. NB. Sales data are automatically recorded by the online ordering system.
Timepoint [2] 328807 0
Timepoint: Baseline – the 4-week period immediately preceding intervention commencement. Follow-up – the 4-week period post intervention commencement

Eligibility
Key inclusion criteria
Government primary schools in NSW, Australia, with an operational canteen, who have been using an online lunch ordering service with ‘Flexischools’ (provider of online lunch order services) for at least 6 months, and that process a minimum of 50 student lunch orders per month, will be eligible to participate.
Minimum age
5 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Special purpose schools catering for student with special needs (e.g. juvenile justice or schools serving hospitalized children) will be excluded due to potential differences in the provision of foods in these settings.

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)
Central randomisation by computer
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software (i.e. computerised sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
25/07/2016
Date of last participant enrolment
Anticipated
Actual
20/10/2016
Date of last data collection
Anticipated
2/12/2016
Actual
2/12/2016
Sample size
Target
2000
Accrual to date
Final
1938
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 294824 0
University
Name [1] 294824 0
The University of Newcastle
Country [1] 294824 0
Australia
Funding source category [2] 294825 0
Government body
Name [2] 294825 0
Hunter New England Population Health
Country [2] 294825 0
Australia
Primary sponsor type
University
Name
The University of Newcastle
Address
University Drive, Callaghan NSW 2308
Australia
Country
Australia
Secondary sponsor category [1] 293669 0
Government body
Name [1] 293669 0
Hunter New England Population Health
Address [1] 293669 0
Longworth Avenue, Wallsend NSW 2287
AUSTRALIA
Country [1] 293669 0
Australia
Other collaborator category [1] 279290 0
Commercial sector/Industry
Name [1] 279290 0
Flexischools
Address [1] 279290 0
5 Victoria Parade, Manly, NSW 2095
AUSTRALIA
Country [1] 279290 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 296215 0
Hunter New England Human Research Ethics Committee
Ethics committee address [1] 296215 0
Ethics committee country [1] 296215 0
Australia
Date submitted for ethics approval [1] 296215 0
18/04/2016
Approval date [1] 296215 0
09/05/2016
Ethics approval number [1] 296215 0
06/07/26/4.04

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

Contacts
Principal investigator
Name 70026 0
Dr Rebecca Wyse
Address 70026 0
C/o Hunter New England Population Health
Locked Bag 10
WALLSEND NSW 2387
Country 70026 0
Australia
Phone 70026 0
+61 2 4924 6477
Fax 70026 0
+61 2 4924 6490
Email 70026 0
[email protected]
Contact person for public queries
Name 70027 0
Rebecca Wyse
Address 70027 0
C/o Hunter New England Population Health
Locked Bag 10
WALLSEND NSW 2387
Country 70027 0
Australia
Phone 70027 0
+61 2 4924 6477
Fax 70027 0
+61 2 4924 6490
Email 70027 0
[email protected]
Contact person for scientific queries
Name 70028 0
Rebecca Wyse
Address 70028 0
C/o Hunter New England Population Health
Locked Bag 10
WALLSEND NSW 2387
Country 70028 0
Australia
Phone 70028 0
+61 2 4924 6477
Fax 70028 0
+61 2 4924 6490
Email 70028 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
Data owned by third party and our ethics restricts us from sharing beyond the scope of the trial.


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.