Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621000564853
Ethics application status
Approved
Date submitted
17/03/2021
Date registered
13/05/2021
Date last updated
13/04/2023
Date data sharing statement initially provided
13/05/2021
Date results provided
13/04/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
VegUP: The effect of a vegetable-focused menu in primary school canteens
Scientific title
Effect of a vegetable-focus in primary school canteen menus on vegetable sales: a randomised controlled trial
Secondary ID [1] 303715 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
low vegetable intake 321139 0
poor diet 321538 0
Condition category
Condition code
Public Health 318942 318942 0 0
Health promotion/education
Diet and Nutrition 318954 318954 0 0
Other diet and nutrition disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention consists of increased vegetable provision and online ordering changes in NSW primary school canteen menu's for an 8-week period. The menu changes consists of the following elements:

1. Novel vegetable-containing product
A new vegetable-containing product ‘Rainbow Dippers’ will be introduced. This product concept was developed based on sensory science and knowledge on children’s food acceptance. The product contains a range of vegetable dippers which include a dipper (raw vegetable sticks) and a vegetable dip, and it will contain one serve of vegetables. The product was developed using insights from a consumer sensory acceptance test with children. The product will adhere to school guidelines concerning allergies and will be produced by a commercial producer and delivered for free to schools during the intervention period.

2. Changes to online menu structure/choice architecture
Two changes will be made to the online menu structure:
- Positioning changes will be made to fit with the “primacy effect” – the tendency to pay more attention to the first items in a list. Vegetable-containing items will be positioned higher than non-vegetable-containing items in their categories in the (online) menus.
- Sandwiches with a protein component (e.g. cheese/ham/turkey/chicken) will contain one vegetable filling by default, to which parents can opt-out. Currently, parents/children need to opt-in for a vegetable filling. This strategy is based on the finding that decision makers have a tendency to choose the default among several possible actions, as a result of ‘loss aversion’.

3. Changes to hot foods
The vegetable content in popular hot foods will be increased through recipe development, undertaken in collaboration with the canteen manager. An earlier menu analysis of primary school menus in NSW showed that only 49% of hot meals/foods contained vegetables. Canteen managers will be provided with advice and support on how the vegetable content of their most popular hot meals can be increased. They are encouraged to include students in the school to take part in a ‘taste test’ to select the winning recipes that will be introduced, in order to create student engagement.

4. Brochure with other suggestions to increase vegetable content
Canteen managers will be provided with a leaflet containing other suggestions to increase the vegetable content of their menu. These suggestions are based on the results of a previous menu analysis for opportunities to increase the vegetable content of canteen menu’s. The possibilities to implement changes will be discussed individually with each canteen manager to fit around their current menu and practices.

Canteen managers will be provided with an information pack on the changes which will be individually discussed and tailored to their situation by a research staff member with nutrition qualifications. Canteen managers can choose themselves how and which of the changes they will implement to fit with their schools, students and canteens needs. From the intervention perspective there will be no other changes to the foods other than addition of vegetables and order of items on menus. If canteen managers feel they need to withdraw a food item to comply with their menu policy (e.g. if addition of a new snack would require removal of another snack) then we will allow them to implement that. This additional change would then be recorded.

Parents, students and staff will be informed about the menu changes after collection of baseline data (and before the new menu is introduced) via the school’s regular communication channels.

All physical information materials were designed specifically for this study.

Intervention adherence will be checked by recording which initial changes to the menu the canteen managers will implement, and a phone call mid-way and at the end of the intervention. In addition, weekly checks of the online menu will be conducted and delivery records of vegetables supplied by the commercial provider will be kept.
Intervention code [1] 320023 0
Prevention
Intervention code [2] 320024 0
Behaviour
Intervention code [3] 320252 0
Lifestyle
Comparator / control treatment
Control schools will follow their usual practices. They will be instructed not to change anything in their menu during both the baseline and intervention period. They will also be requested to maintain the status quo with regard to recipes and other practices.
Control group
Active

Outcomes
Primary outcome [1] 326869 0
Overall vegetable sales (g/week), derived from canteen sales data

- Menus of participating schools will be assessed by a trained dietitian experienced in reviewing school canteen menus. Vegetable content (in g) will be determined for each vegetable-containing item on the online menu. Where needed, specific information from the canteen manager will be sought
- Daily individual sales data from canteens from online ordering will be used
- Any over-the counter-sales of vegetable-containing items will be manually recorded on a check-list by canteen managers
- Vegetables sold will be calculated by multiplying the number of vegetable-containing items sold each day by the vegetable content (in g) of the items. Daily vegetable sales will be converted to weekly sales by adding daily totals.
Timepoint [1] 326869 0
Baseline data collection will take place over 3 weeks in the first term of the school winter menu (term 2 of 2021). Follow-up data collection will take place over 8 weeks of the intervention in school term 1 of 2022.
Secondary outcome [1] 392921 0
Vegetable sales (g/wk) in specific categories (e.g. sandwiches, snacks)

Menu items will be grouped into subcategories. Vegetable sales data in relevant subcategories will be captured and analysed in the same way as for the overall vegetable sales.
Timepoint [1] 392921 0
Baseline data collection will take place over 3 weeks in the first term of the school winter menu (term 2 of 2021). Follow-up data collection will take place over 8 weeks of the intervention in school term 1 of 2022.
Secondary outcome [2] 392922 0
Canteen revenue sales (in AUS$/week)

To determine that the intervention does not adversely affect canteen sales, total revenue data will be collected from online ordering data and over-the-counter cash register data
Timepoint [2] 392922 0
Baseline data collection will take place over 3 weeks in the first term of the school winter menu (term 2 of 2021). Follow-up data collection will take place over 8 weeks of the intervention in school term 1 of 2022.
Secondary outcome [3] 392924 0
Vegetable waste (g/week)

To verify if vegetable sales is a good approximation of vegetable intake, student vegetable waste will be collected from school grounds from a random sample of 4 participating intervention (n=2) and control (n=2) schools. Dedicated bins will be provided during test days. Waste will be collected by research staff, sorted for vegetable items and weighed on the same day.
Timepoint [3] 392924 0
Vegetable waste will be measured over 2 representative days mid-baseline and mid-intervention period.
Secondary outcome [4] 392925 0
Process evaluation data from canteen managers of intervention schools.

An online survey (closed and open questions) will be undertaken with canteen managers to evaluate the perception of student interest on specific elements of the intervention, implementation difficulties, long-term viability and potential improvements. The survey was designed specifically for this study.
Timepoint [4] 392925 0
Within three weeks after completion of the intervention period
Secondary outcome [5] 392926 0
Process evaluation amongst parents in intervention schools

An online quantitative survey will be undertaken with parents of students to seek information on menu perception and behavioural changes using a combination of multiple choice questions and 7-point Likert scales. All eligible parents from the participating intervention schools will be invited to take part. The survey was designed specifically for this study.
Timepoint [5] 392926 0
Within three weeks after completion of the intervention period
Secondary outcome [6] 394045 0
Process evaluation data from canteen managers of intervention schools.

After the online survey, a follow up phone call will be undertaken with canteen managers when needed to be able to get deeper insights and clarify answers.
Timepoint [6] 394045 0
Within 1-2 weeks after completion of the online survey

Eligibility
Key inclusion criteria
Schools (through principals) and canteen managers in metropolitan Sydney (NSW) will be recruited that meet the following inclusion criteria:
- Government, independent and catholic primary schools (Kindergarten - Year 6) with a school canteen
- School canteen is operating with an online ordering system (Cashless) with more than 70% of sales done online
- School canteen is operating at least 3 days a week
- Principals are willing to let their school participate and are willing to share de-identified sales data (provided by online ordering system provider)
- Canteen managers are willing to implement changes to their vegetable provision and participate in a follow up survey

For the process evaluation, parents will be eligible for participation when:
- Child is enrolled in intervention school
- Parent regularly (at least once a week) orders food for their child from the school canteen via online ordering
- Parent does not exclusively order foods via recurring ordering
Minimum age
5 Years
Maximum age
12 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Exclusion criteria for schools:
- Schools registered as a Special Needs school
- Combined schools (K-12)

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)
One-to-one ratio of allocation to treatment or control. Randomised stratified allocation by SES level of school suburb (low/medium/high) created by computer software by an independent statistician.
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
Vegetable sales data (g/week) and total sales ($/week) will be analysed using repeated measures analysis of variance using intervention arm (intervention or control) as between-subject variable and time point (week) as repeated measures. Planned contrasts (compare to baseline period) will be undertaken as post-hoc measurements.

Vegetable waste data (g) will be analysed using two-way ANOVA with intervention arm and time point as factors.

Outcomes from the process evaluation (canteen managers, parents) will not be statistically analysed, but reported as means (interval data) and frequencies (nominal data) for quantitative variables.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
21/05/2021
Actual
27/05/2021
Date of last participant enrolment
Anticipated
Actual
10/02/2022
Date of last data collection
Anticipated
Actual
30/04/2022
Sample size
Target
500
Accrual to date
Final
4302
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 308127 0
Commercial sector/Industry
Name [1] 308127 0
Horticulture Australia Innovations Limited
Country [1] 308127 0
Australia
Primary sponsor type
Government body
Name
Commonwealth Industrial and Scientific Research Organisation
Address
11 Julius Avenue, North Ryde NSW 2113
Country
Australia
Secondary sponsor category [1] 308885 0
None
Name [1] 308885 0
Address [1] 308885 0
Country [1] 308885 0
Other collaborator category [1] 281689 0
Charities/Societies/Foundations
Name [1] 281689 0
Healthy Kids Association
Address [1] 281689 0
Suite 1.02/38 Oxley St, St Leonards NSW 2065
Country [1] 281689 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 308113 0
CSIRO Health and Medical Research Human Research Ethics Committee
Ethics committee address [1] 308113 0
Ethics committee country [1] 308113 0
Australia
Date submitted for ethics approval [1] 308113 0
11/12/2020
Approval date [1] 308113 0
17/12/2020
Ethics approval number [1] 308113 0
2020_120_LR
Ethics committee name [2] 308114 0
State Education Research Approval Process (SERAP)
Ethics committee address [2] 308114 0
Ethics committee country [2] 308114 0
Australia
Date submitted for ethics approval [2] 308114 0
05/02/2021
Approval date [2] 308114 0
30/03/2021
Ethics approval number [2] 308114 0
2021011

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

Contacts
Principal investigator
Name 109582 0
Dr Astrid Poelman
Address 109582 0
CSIRO, 11 Julius Avenue North Ryde NSW 2113
Country 109582 0
Australia
Phone 109582 0
+61 2 9490 8356
Fax 109582 0
Email 109582 0
[email protected]
Contact person for public queries
Name 109583 0
Astrid Poelman
Address 109583 0
CSIRO, 11 Julius Avenue North Ryde NSW 2113
Country 109583 0
Australia
Phone 109583 0
+61 2 9490 8356
Fax 109583 0
Email 109583 0
[email protected]
Contact person for scientific queries
Name 109584 0
Astrid Poelman
Address 109584 0
CSIRO, 11 Julius Avenue North Ryde NSW 2113
Country 109584 0
Australia
Phone 109584 0
+61 2 9490 8356
Fax 109584 0
Email 109584 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
SourceTitleYear of PublicationDOI
EmbaseEffectiveness of a Multi-Strategy Behavioral Intervention to Increase Vegetable Sales in Primary School Canteens: A Randomized Controlled Trial.2022https://dx.doi.org/10.3390/nu14194218
N.B. These documents automatically identified may not have been verified by the study sponsor.