Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12620001338954
Ethics application status
Approved
Date submitted
7/09/2020
Date registered
11/12/2020
Date last updated
11/12/2020
Date data sharing statement initially provided
11/12/2020
Type of registration
Retrospectively registered

Titles & IDs
Public title
A cluster randomised controlled trial of the impact of a multi-strategy behavioural intervention on the nutritional quality of secondary school student food purchases from online canteens.
Scientific title
A cluster randomised controlled trial of the impact of a multi-strategy behavioural intervention on the nutritional quality of secondary school student food purchases from online canteens.
Secondary ID [1] 302253 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Poor diet 318973 0
Obesity 319392 0
Condition category
Condition code
Diet and Nutrition 316941 316941 0 0
Obesity
Public Health 316942 316942 0 0
Health promotion/education

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The aim of this study is to assess the effectiveness of integrating consumer behaviour strategies (including menu labelling, item positioning, tailored feedback, and prompts) into an online canteen ordering system, to improve the nutritional quality of foods purchases by secondary school students via online canteens.

This study will employ a clustered randomised controlled trial design. Ten NSW secondary schools with an existing online canteen ordering system will be randomised to receive either a consumer behaviour intervention or control (online canteen ordering only).

All users of an online canteen at intervention schools will receive a consumer behaviour intervention that will be integrated into the school's existing online canteen ordering system, for 2 months. Online canteen ordering systems allow users 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 breaks.

1. Labelling: Each item on the online menu will be labelled with a coloured symbol. The labelling system is based on the NSW Healthy School Canteen Strategy. Small symbols will appear next to each menu item; a green circle for “Everyday” foods; an amber circle for “Occasional” foods; and a red symbol for “Should not be sold” foods.

2. Positioning: Menus items will be ordered to give healthy items positions of greatest prominence. This will occur at the food category level (e.g. Drinks) and at the item level (e.g. Strawberry Flavoured Milk). The healthiest food categories / items will be positioned first. Where there are multiple flavours of an ‘Occasional’ foods (e.g. multiple flavours of chips), users will be required to first ‘click’ on the item before the full list of flavours are displayed.

3. Feedback: Prior to each lunch order being confirmed within the online ordering system, the user will receive feedback summarising the nutritional content of the order. This will take on the form of a pie chart displaying the proportion of ‘Everyday’ vs ‘Occasional’ foods selected and explanatory text. Users will have the option to amend or modify their order prior to purchasing.

4. Prompts: When a user selects an “Occasional” or “Should not be sold” hot food item, the user will receive a prompt to include a healthy add-ons (e.g. water and/or fruit or vegetable snack).

The labels will be manually added to the online menus by the online canteen provider (based on a template provided by the research team). The online canteen provider will reprogram the website of intervention schools to automatically apply the positioning and feedback strategies to online menus based on the assigned label. The prompts will be manually added by the online provider.

The research team will also provide the canteen managers from intervention schools with a menu feedback report. This feedback report will classified according to the NSW Healthy School Canteen strategy and each menu item will be categorised as 'Everyday', 'Occasional' and 'Should not be sold', by a research dietitian. The feedback report will also include graphical feedback comparing the canteen menu to the recommendations of the NSW Healthy School Canteen Strategy (i.e. 'Everyday' foods should comprise at least 75% of the menu, and 'Should not be sold' foods should be removed from the menu).
Intervention code [1] 318540 0
Behaviour
Comparator / control treatment
Schools allocated to the control group will have access to the standard online ordering system only.
Control group
Active

Outcomes
Primary outcome [1] 325043 0
The proportion of all items purchased online that are 'Everyday', according to the NSW Healthy School Canteen Strategy. Based on lunch order purchasing data that is automatically recorded by the online ordering system.
Timepoint [1] 325043 0
Baseline (all online lunch orders placed during the 2-month period immediately preceding intervention commencement when the canteen is operational) and follow-up (all online lunch orders placed during the 2-month period post-intervention commencement when the canteen is operational).
Primary outcome [2] 325044 0
The proportion of all items purchased online that are ‘Occasional’, according to the NSW Healthy School Canteen Strategy. Based on lunch order purchasing data that is automatically recorded by the online ordering system.
Timepoint [2] 325044 0
Baseline (all online lunch orders placed during the 2-month period immediately preceding intervention commencement when the canteen is operational) and follow-up (all online lunch orders placed during the 2-month period post-intervention commencement when the canteen is operational).
Primary outcome [3] 325045 0
The proportion of all items purchased online that are 'Should Not Be Sold', according to the NSW Healthy School Canteen Strategy. Based on lunch order purchasing data that is automatically recorded by the online ordering system.
Timepoint [3] 325045 0
Baseline (all online lunch orders placed during the 2-month period immediately preceding intervention commencement when the canteen is operational) and follow-up (all online lunch orders placed during the 2-month period post-intervention commencement when the canteen is operational).
Secondary outcome [1] 386661 0
The average energy (kilojoule) content of student online orders using purchasing data that is automatically collected by the online ordering system.
Timepoint [1] 386661 0
Baseline (all online lunch orders placed during the 2-month period immediately preceding intervention commencement when the canteen is operational) and follow-up (all online lunch orders placed during the 2-month period post-intervention commencement when the canteen is operational).
Secondary outcome [2] 386662 0
The average saturated fat (grams) content of student online orders using purchasing data that is automatically collected by the online ordering system.
Timepoint [2] 386662 0
Baseline (all online lunch orders placed during the 2-month period immediately preceding intervention commencement when the canteen is operational) and follow-up (all online lunch orders placed during the 2-month period post-intervention commencement when the canteen is operational).
Secondary outcome [3] 386663 0
The average sugar (grams) content of student online orders using purchasing data that is automatically collected by the online ordering system.
Timepoint [3] 386663 0
Baseline (all online lunch orders placed during the 2-month period immediately preceding intervention commencement when the canteen is operational) and follow-up (all online lunch orders placed during the 2-month period post-intervention commencement when the canteen is operational).
Secondary outcome [4] 386664 0
The average sodium (mg) content of students online orders using purchasing data that is automatically collected by the online ordering system.
Timepoint [4] 386664 0
Baseline (all online lunch orders placed during the 2-month period immediately preceding intervention commencement when the canteen is operational) and follow-up (all online lunch orders placed during the 2-month period post-intervention commencement when the canteen is operational).
Secondary outcome [5] 386665 0
Weekly revenue from online orders, data which is automatically collected by the online ordering system.
Timepoint [5] 386665 0
Baseline (all online lunch orders placed during the 2-month period immediately preceding intervention commencement when the canteen is operational) and follow-up (all online lunch orders placed during the 2-month period post-intervention commencement when the canteen is operational).
Secondary outcome [6] 386667 0
Recess purchases: The proportion of all recess items purchased online that are: ‘Everyday’, ‘Occasional’, ‘Should not be sold’ (composite secondary outcome).
Timepoint [6] 386667 0
Baseline (all online recess orders placed during the 2-month period immediately preceding intervention commencement when the canteen is operational) and follow-up (all online recess orders placed during the 2-month period post-intervention commencement when the canteen is operational).

Eligibility
Key inclusion criteria
1. NSW secondary schools which are currently using an online canteen ordering system provided by Flexischools.
2. All secondary school student orders placed online during any of the data collection periods within participating schools will be included.
Minimum age
12 Years
Maximum age
19 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Special purpose schools catering for students with special needs (e.g. juvenile justice or schools serving hospitalised children) were 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)
Following school consent, a statistician will randomly allocate schools to intervention or control conditions using a computer generated random number function.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computer random number function will randomised schools in a 1:1 ratio to intervention or control group. Randomisation will be stratified by school sector.
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
Recruiting
Date of first participant enrolment
Anticipated
Actual
30/10/2020
Date of last participant enrolment
Anticipated
1/04/2021
Actual
Date of last data collection
Anticipated
30/04/2021
Actual
Sample size
Target
1040
Accrual to date
600
Final
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 306675 0
Charities/Societies/Foundations
Name [1] 306675 0
Heart Foundation
Country [1] 306675 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] 307523 0
None
Name [1] 307523 0
Address [1] 307523 0
Country [1] 307523 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 306854 0
The University of Newcastle Human Research Ethics Committee (HREC)
Ethics committee address [1] 306854 0
The University of Newcastle,
1 University Drive,
Callaghan NSW 2308,
Australia
Ethics committee country [1] 306854 0
Australia
Date submitted for ethics approval [1] 306854 0
03/08/2020
Approval date [1] 306854 0
05/08/2020
Ethics approval number [1] 306854 0
H-2017-0402
Ethics committee name [2] 307109 0
NSW Department of Education
Ethics committee address [2] 307109 0
Level 9, 105 Phillip Street, Parramatta NSW 2150 | GPO Box 33, Sydney NSW 2001
Ethics committee country [2] 307109 0
Australia
Date submitted for ethics approval [2] 307109 0
31/08/2020
Approval date [2] 307109 0
13/10/2020
Ethics approval number [2] 307109 0
SERAP 2018065

Summary
Brief summary
The aim of this study is to assess the effectiveness of integrating consumer behaviour strategies (including menu labelling, item positioning, tailored feedback & prompts) into an online canteen ordering system, to improve the nutritional quality of foods purchased by secondary school students via online canteens. This study will employ a clustered randomised controlled design. Ten NSW secondary schools currently using an online canteen ordering system will be randomised in a 1:1 ratio to receive either the intervention or control (standard online ordering only). Intervention effectiveness will be assessed via between group differences in the proportion of online orders classified as ‘Everyday’, ‘Occasional’ or ‘Should Not Be Sold’ according to the NSW Healthy School Canteen Strategy, using purchase data automatically recorded by the online ordering system at baseline (the 2-month period prior to intervention commencement) and follow up (the 2-month period immediately post-intervention commencement).
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 105242 0
Dr Rebecca Wyse
Address 105242 0
The University of Newcastle, Australia
University Dr, Callaghan NSW 2308
Country 105242 0
Australia
Phone 105242 0
+61 2 4924 6310
Fax 105242 0
Email 105242 0
[email protected]
Contact person for public queries
Name 105243 0
Ms Tessa Delaney
Address 105243 0
University of Newcastle
School of Medicine and Pubic Health
c/o Hunter New England Population Health
Locked Bag 10 Wallsend NSW 2287
Country 105243 0
Australia
Phone 105243 0
+61 2 4924 6499
Fax 105243 0
+61 2 4924 6490
Email 105243 0
[email protected]
Contact person for scientific queries
Name 105244 0
Ms Tessa Delaney
Address 105244 0
University of Newcastle
School of Medicine and Pubic Health
c/o Hunter New England Population Health
Locked Bag 10 Wallsend NSW 2287
Country 105244 0
Australia
Phone 105244 0
+61 2 4924 6499
Fax 105244 0
+61 2 4924 6490
Email 105244 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
In accordance with ethics approvals


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.