Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12616000499482
Ethics application status
Approved
Date submitted
11/04/2016
Date registered
18/04/2016
Date last updated
14/12/2017
Type of registration
Prospectively registered

Titles & IDs
Public title
Pilot of an online multi-component public health nutrition intervention to improve healthy food purchases from primary school canteens – A pilot cluster randomised controlled trial
Scientific title
The efficacy of a multi-component online canteen lunch ordering intervention versus standard online canteen lunch ordering in improving the kilojoule, saturated fat, sodium, and sugar content of foods and beverages purchased by primary school students
Secondary ID [1] 288967 0
None
Universal Trial Number (UTN)
Nil
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Child Diet 298349 0
Condition category
Condition code
Diet and Nutrition 298459 298459 0 0
Obesity
Public Health 298460 298460 0 0
Health promotion/education
Public Health 298461 298461 0 0
Health service research

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Eligible schools using an online lunch ordering service will be approached and randomised to receive an online multi-component public health nutrition intervention. The aim of the intervention is to increase the purchase of healthy food and beverage menu items from school canteens using an online lunch ordering service.The following evidence-based strategies will be employed:

1. Availability: Canteen managers will be supported to improve the relative availability of healthy items sold at their canteen. Specifically, a dietitian will classify foods and beverages sold by schools as ‘red’ (low in nutritional value), ‘amber’ (moderate nutritional value) or ‘green’ (high nutritional value) according to NSW government school canteen policy ‘Fresh Tastes @ School’ and provide a comprehensive feedback report to schools encouraging canteen managers to improve the relative availability of healthy items ('green') by increasing the availability of healthy items (green) or removing unhealthy items (red) from menus. These reports will be distributed via email to both the canteen manager and Principal at a minimum of 1 time point, immediately prior to the redesigned canteen menu being uploaded online. A brief phone call (approx.15 minutes) will be made to the canteen manager and/or Principal to discuss contents of the feedback report.

2. Labelling:
a. Traffic light labels - Each online menu item will be labelled with a single traffic-light label based on the Fresh Tastes @ School classification (red, amber or green).
b. Label Guide - A definition of ‘green’, ‘amber’ and ‘red’ foods will appear at the top of webpage, and when user hovers their mouse over each traffic light symbol
c. Descriptions – Green menu items that require assembly of ingredients and that are commonly purchased as a main meal item (e.g. Sandwiches/Salads/ homemade hot meals) will include a hedonic description directly under the item name.

3. Placement: Healthier menu categories (i.e. fruit, sandwiches, salads) and items within categories will be will be ordered to give ‘green’ items positions of greatest prominence i.e. positioned first. Where there are multiple flavours of a ‘red’ or ‘amber’ food, users will be required to ‘click’ on the category before the full list of items are displayed. Conversely, all ‘green’ items will appear in the main website interface.

4. Prompting: Healthier menu categories (i.e. sandwiches, salads, fruit) will display images and a positive purchase prompt. When users select a red or amber hot food item they will also be provided with a suite of green add-ons (water, fruit or vegetable) called ‘meal extras’.

Schools in the intervention group will be required to retain the menu design throughout the study period (for a minimum of 2 months).

Intervention Fidelity:

The research team will have access to a school’s online menu in its ‘build phase’, this will minimise error in the application of intervention strategies from the online provider. The online provider will also supply the research team with monthly reports describing changes made to the menu over the preceding month. These reports will enable the research team to identify the addition of new menu items. New menu items will be labelled and positioned according to the redesign strategies. The research team will contact the provider to make the required changes.
Intervention code [1] 294451 0
Prevention
Intervention code [2] 294452 0
Behaviour
Intervention code [3] 294453 0
Lifestyle
Comparator / control treatment
Schools allocated to the control group will continue to receive the standard online lunch ordering service.
Control group
Active

Outcomes
Primary outcome [1] 297952 0
Primary Outcome 1: The mean energy (kilojoule) content per student online lunch order based on nutritional assessment of purchasing data automatically collected by the online ordering system
Timepoint [1] 297952 0
Baseline (the 2-month period immediately preceding intervention commencement when the canteen is operational) and follow-up (the 2-month period post-intervention commencement when the canteen is operational)
Primary outcome [2] 297953 0
Primary Outcome 2: 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
Timepoint [2] 297953 0
Baseline (the 2-month period immediately preceding intervention commencement when the canteen is operational) and follow-up (the 2-month period post-intervention commencement when the canteen is operational)
Primary outcome [3] 298004 0
Primary Outcome 3: The mean sodium (mg) content per student online lunch order based on nutritional assessment of purchasing data automatically collected by the online ordering system
Timepoint [3] 298004 0
Baseline (the 2-month period immediately preceding intervention commencement when the canteen is operational) and follow-up (the 2-month period post-intervention commencement when the canteen is operational)
Secondary outcome [1] 322879 0
Primary Outcome 4: The mean sugar (grams) content per student online lunch order based on nutritional assessment of purchasing data automatically collected by the online ordering system
Timepoint [1] 322879 0
Baseline (the 2-month period immediately preceding intervention commencement when the canteen is operational) and follow-up (the 2-month period post-intervention commencement when the canteen is operational)
Secondary outcome [2] 322880 0
The proportion per student, of all online lunch order items purchased that are ‘green’ based on nutritional assessment of purchasing data automatically collected by the online ordering system
Timepoint [2] 322880 0
Baseline (the 2-month period immediately preceding intervention commencement when the canteen is operational) and follow-up (the 2-month period post-intervention commencement when the canteen is operational)
Secondary outcome [3] 322881 0
The proportion per student, of all online lunch order items purchased that are ‘red’ based on nutritional assessment of purchasing data automatically collected by the online ordering system
Timepoint [3] 322881 0
Baseline (the 2-month period immediately preceding intervention commencement when the canteen is operational) and follow-up (the 2-month period post-intervention commencement when the canteen is operational)
Secondary outcome [4] 322884 0
Secondary Outcome 3: Sales data automatically collected by the online system will be used to calculate canteen revenue.
Timepoint [4] 322884 0
Baseline (the 2-month period immediately preceding intervention commencement when the canteen is operational) and follow-up (the 2-month period post-intervention commencement when the canteen is operational)
Secondary outcome [5] 327739 0
The mean percent energy (kilojoules) coming from saturated fat per student online lunch order based on nutritional assessment of purchasing data automatically collected by the online ordering system
Timepoint [5] 327739 0
Baseline (the 2-month period immediately preceding intervention commencement when canteen was operational) and follow-up (the 2-month period post-intervention commencement when the canteen was operational).
Secondary outcome [6] 327740 0
The mean percent energy (kilojoules) coming from sugar per student online lunch order based on nutritional assessment of purchasing data automatically collected by the online ordering system
Timepoint [6] 327740 0
Baseline (the 2-month period immediately preceding intervention commencement when canteen was operational) and follow-up (the 2-month period post-intervention commencement when the canteen was operational).

Eligibility
Key inclusion criteria
To be eligible, the school must be a government primary school with an operational canteen that has been using an online lunch ordering service with Flexischools (a provider of online canteen services to primary schools) for at least 6 months, process a minimum of 50 student lunch orders per month; be located in NSW. Students must have placed an order during the baseline data collection period (the 2-month period immediately preceding intervention commencement) to be included in study
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 students with special needs, juvenile justice or schools serving hospitalised children will be excluded due to the potential differences in the provision of foods in these settings. Schools from the Catholic or Independent Schools Association will be ineligible as implementation of the Fresh Tastes @ School canteen policy is not mandated for such schools. Schools already employing point of purchase nutrition labelling (similar to that of the intervention) will also be 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)
A list of eligible schools will be supplied by the provider of online canteen services. A convenience sample of schools from the sampling frame will be approached via mail and telephone to participate. Study information and consent forms will be mailed to schools approximately one week prior to a telephone call from a research assistant requesting consent to participate in the trial. Recruitment will continue until the required sample of schools consent to participate. Following school consent, a statistician will randomly allocate schools to intervention or control conditions in a 1:1 ratio via a block randomisation using a random number function in Microsoft Excel.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Consenting schools will be randomly allocated to an intervention or control group in a 1:1 ratio via block randomisation using a random number function in Microsoft Excel following recruitment. The procedure will be stratified by the socioeconomic status of school locality (based on postcode).
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
6/06/2016
Actual
25/07/2016
Date of last participant enrolment
Anticipated
Actual
27/09/2016
Date of last data collection
Anticipated
Actual
20/12/2016
Sample size
Target
1040
Accrual to date
Final
2741
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 293324 0
University
Name [1] 293324 0
University of Newcastle
Country [1] 293324 0
Australia
Funding source category [2] 293325 0
Government body
Name [2] 293325 0
Hunter New England Population Health
Country [2] 293325 0
Australia
Primary sponsor type
University
Name
University of Newcastle
Address
University Drive, Callaghan NSW 2308
Country
Australia
Secondary sponsor category [1] 292143 0
Government body
Name [1] 292143 0
Hunter New England Population Health
Address [1] 292143 0
Longworth Avenue, Wallsend, NSW 2287
Country [1] 292143 0
Australia
Other collaborator category [1] 278938 0
Commercial sector/Industry
Name [1] 278938 0
Flexischools
Address [1] 278938 0
5 Victoria Parade, Manly, NSW 2095
Country [1] 278938 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 294795 0
Hunter New England Human Research Ethics Committee
Ethics committee address [1] 294795 0
Hunter New England Health Locked Bag 1, New Lambton NSW 2305
Ethics committee country [1] 294795 0
Australia
Date submitted for ethics approval [1] 294795 0
Approval date [1] 294795 0
10/11/2015
Ethics approval number [1] 294795 0
06/07/26/4.04
Ethics committee name [2] 296522 0
University of Newcastle Hunter Research Ethics Committee
Ethics committee address [2] 296522 0
Research Integrity Unit
NIER, Block C
The University of Newcastle
Callaghan NSW 230
Ethics committee country [2] 296522 0
Australia
Date submitted for ethics approval [2] 296522 0
Approval date [2] 296522 0
Ethics approval number [2] 296522 0
H-2008-0343

Summary
Brief summary
School canteens represent an ideal setting in which to deliver public health nutrition strategies given their wide reach, frequent use and access by children. Online lunch ordering services in school canteens represent an attractive opportunity to deliver public health interventions to improve healthy canteen purchases at scale with high fidelity. The aim of this study is to assess the efficacy of an online intervention in reducing the total energy, saturated fat, sodium and sugar content of online lunch purchases for primary school students. The study will employ a cluster randomised controlled trial design, with schools currently using an online canteen ordering system randomised in a 1:1 ratio to receive either the intervention or control (standard online ordering only). The intervention will include the evidence based strategies shown to influence healthy food purchasing (availability, menu labelling, placement and prompting). The intervention will be assessed through between group comparison of nutritional analysis of purchasing data automatically recorded by the online ordering system over a 2 -month period post-intervention commencement.
Trial website
Trial related presentations / publications
Link to trial outcome published in American Journal of Clinical Nutrition
http://ajcn.nutrition.org/content/early/2017/09/27/ajcn.117.158329.abstract
Public notes

Contacts
Principal investigator
Name 65070 0
Dr Rebecca Wyse
Address 65070 0
University of Newcastle
School of Medicine and Pubic Health
c/o Hunter New England Population Health
Locked Bag 10 Wallsend NSW 2287
Country 65070 0
Australia
Phone 65070 0
+61249246499
Fax 65070 0
+61249246490
Email 65070 0
[email protected]
Contact person for public queries
Name 65071 0
Ms Tessa Delaney
Address 65071 0
University of Newcastle
School of Medicine and Pubic Health
c/o Hunter New England Population Health
Locked Bag 10 Wallsend NSW 2287
Country 65071 0
Australia
Phone 65071 0
+61249246499
Fax 65071 0
+61249246490
Email 65071 0
[email protected]
Contact person for scientific queries
Name 65072 0
Dr Rebecca Wyse
Address 65072 0
University of Newcastle
School of Medicine and Pubic Health
c/o Hunter New England Population Health
Locked Bag 10 Wallsend NSW 2287
Country 65072 0
Australia
Phone 65072 0
+61249246499
Fax 65072 0
+61249246490
Email 65072 0
[email protected]

No information has been provided regarding IPD availability


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.