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Trial registered on ANZCTR


Registration number
ACTRN12619001150134
Ethics application status
Approved
Date submitted
16/07/2019
Date registered
16/08/2019
Date last updated
16/08/2019
Date data sharing statement initially provided
16/08/2019
Type of registration
Retrospectively registered

Titles & IDs
Public title
The relative impact of menu labelling versus tailored feedback on the purchase of healthier food from primary school online canteens: A cluster randomized controlled trial
Scientific title
The relative impact of menu labelling versus tailored feedback on the purchase of healthier food from primary school online canteens: A cluster randomised controlled trial
Secondary ID [1] 298744 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
poor diet 313676 0
obesity
 313764 0
Condition category
Condition code
Diet and Nutrition 312089 312089 0 0
Obesity
Public Health 312090 312090 0 0
Health promotion/education

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Feedback (to parents and students):
i)Feedback to parents and students: Prior to each lunch order being confirmed within the online ordering system, Users will be shown a pie-chart displaying the proportion of ‘Everyday’ (definition: Foods to eat everyday), ‘Occasional' (definition: foods to eat sometimes an din small amounts) and ‘Caution – consider switching’ (definition: foods should not be sold in the canteen) items contained within the lunch order. Users will be able to change their order at this point, and the graph will update to reflect the new order. Furthermore, a tailored message will also appear underneath the pie-chat:
i.100% Everyday: 100% ‘Everyday’ items - Excellent Choice!
ii.50-99% Everyday: At least half of your order is ‘Everyday’ items - Nice Choice
iii.0-49% Everyday: Try adding some ‘Everyday’ items for a more balanced meal

The category definitions and the classification of foods and drinks into these categories was determined by the current state canteen guidelines "The NSW Healthy School Canteen Strategy - Food and drink Criteria'.

Mode of delivery: All users (i.e. parents and students) of an online canteen at participating schools will be exposed to the intervention strategies that will be integrated into the school’s existing online canteen ordering system. Online canteen ordering systems allow users (students or a parent on behalf of a student) to login to a website to access the school’s canteen menu. Users are able to select and pay for food and drink items, which are processed by the canteen and supplied to students during their lunch break.

Who will deliver the intervention: The online canteen provider will modify the display of the online ordering system to incorporate the ‘Pie Graph’ (Tailored feedback intervention (in a random 50% of participating schools).

Intervention delivery schedule: All schools will undergo a 5-week baseline period and a 5-week intervention period.

Intervention Fidelity: A research assistant will monitor the application of the strategies on each school’s online menu via the website of the online canteen provider.
Intervention code [1] 315011 0
Prevention
Intervention code [2] 315012 0
Behaviour
Comparator / control treatment
. No treatment. Control schools receive menu labelling only and no feedback pie-chart or tailored message.

Control schools undergo a 5 week baseline period and a 5 week no intervention period.
Control group
Active

Outcomes
Primary outcome [1] 320736 0
The proportion of all online lunch order items purchased that are classified as ‘Everyday’ based on nutritional assessment of purchasing data automatically collected by the online ordering system through the mobile site.
Timepoint [1] 320736 0
Baseline data collection will take place over a 5-week period. Follow-up data collection will take place over the subsequent 5-week period during which the intervention strategies will be turned on.
Primary outcome [2] 320737 0
The proportion of all online lunch order items purchased that are classified as ‘Caution’ based on nutritional assessment of purchasing data automatically collected by the online ordering system through the mobile site.
Timepoint [2] 320737 0
Baseline data collection will take place over a 5-week period. Follow-up data collection will take place over the subsequent 5-week period during which the intervention strategies will be turned on.
Secondary outcome [1] 372657 0
The mean kilo-joule content per student online lunch order based on nutritional assessment of purchasing data automatically collected by the online ordering system through the mobile site
Timepoint [1] 372657 0
Baseline data collection will take place over a 5-week period. Follow-up data collection will take place over the subsequent 5-week period during which the intervention strategies will be turned on.
Secondary outcome [2] 372658 0
The mean saturated fat (grams) content per student online lunch order based on nutritional assessment of purchasing data automatically collected by the online ordering system through the mobile site
Timepoint [2] 372658 0
Baseline data collection will take place over a 5-week period. Follow-up data collection will take place over the subsequent 5-week period during which the intervention strategies will be turned on.
Secondary outcome [3] 372659 0
The mean sugar (grams) content per student online lunch order based on nutritional assessment of purchasing data automatically collected by the online ordering system through the mobile site.
Timepoint [3] 372659 0
Baseline data collection will take place over a 5-week period. Follow-up data collection will take place over the subsequent 5-week period during which the intervention strategies will be turned on.
Secondary outcome [4] 372660 0
The mean sodium (mg) content per student online lunch order based on nutritional assessment of purchasing data automatically collected by the online ordering system through the mobile site.
Timepoint [4] 372660 0
Baseline data collection will take place over a 5-week period. Follow-up data collection will take place over the subsequent 5-week period during which the intervention strategies will be turned on.
Secondary outcome [5] 372661 0
The online canteen revenue based on purchasing data automatically collected by the online ordering system through the mobile site.
Timepoint [5] 372661 0
Baseline data collection will take place over a 5-week period. Follow-up data collection will take place over the subsequent 5-week period during which the intervention strategies will be turned on.

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 orders 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
Special purpose schools catering for student with special needs (e.g. juvenile justice or schools serving hospitalised children) will be excluded due to potential differences in the provision of foods in these settings. Any schools participating in the long term follow-up of another online canteen research trial being conducted by the research team.

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
N/A
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
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
30/09/2019
Actual
Sample size
Target
4900
Accrual to date
Final
4974
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 303302 0
Government body
Name [1] 303302 0
National Health and Medical Research Council (NHMRC)
Country [1] 303302 0
Australia
Primary sponsor type
Individual
Name
Dr Rebecca Wyse
Address
The University of Newcastle, Australia
University Dr, Callaghan NSW 2308
Country
Australia
Secondary sponsor category [1] 303322 0
None
Name [1] 303322 0
Address [1] 303322 0
Country [1] 303322 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 303835 0
The University of Newcastle Human Research Ethics Committee (HREC)
Ethics committee address [1] 303835 0
Ethics committee country [1] 303835 0
Australia
Date submitted for ethics approval [1] 303835 0
30/11/2017
Approval date [1] 303835 0
22/03/2018
Ethics approval number [1] 303835 0
H-2017-0402
Ethics committee name [2] 303837 0
State Education Research Approval Process (SERAP)
Ethics committee address [2] 303837 0
Ethics committee country [2] 303837 0
Australia
Date submitted for ethics approval [2] 303837 0
13/03/2018
Approval date [2] 303837 0
12/09/2018
Ethics approval number [2] 303837 0
2018065

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

Contacts
Principal investigator
Name 94970 0
A/Prof Luke wolfenden
Address 94970 0
C/o Hunter New England Population Health
Locked Bag 10,
WALLSEND, NSW 2287
Country 94970 0
Australia
Phone 94970 0
+61 02 4924 6510
Fax 94970 0
Email 94970 0
Luke.Wolfenden@newcastle.edu.au
Contact person for public queries
Name 94971 0
Rebecca Wyse
Address 94971 0

C/o Hunter New England Population Health
Locked Bag 10,
WALLSEND, NSW 2287
Country 94971 0
Australia
Phone 94971 0
+610249246510
Fax 94971 0
Email 94971 0
rebecca.wyse@hnehealth.nsw.gov.au
Contact person for scientific queries
Name 94972 0
Rebecca Wyse
Address 94972 0

C/o Hunter New England Population Health
Locked Bag 10,
WALLSEND, NSW 2287
Country 94972 0
Australia
Phone 94972 0
+610249246510
Fax 94972 0
Email 94972 0
rebecca.wyse@hnehealth.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


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.