ANZCTR - Registration

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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]

None

Universal Trial Number (UTN)

Nil

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Child Diet

Poor fruit and vegetable intake

Condition category

Condition code

Diet and Nutrition

Obesity

Public Health

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]

Prevention

Intervention code [2]

Behaviour

Intervention code [3]

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]

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]

Timepoint: Baseline – the 4-week period immediately preceding intervention commencement. Follow-up – the 4-week period post intervention commencement

Secondary outcome [1]

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]

Timepoint: Baseline – the 4-week period immediately preceding intervention commencement. Follow-up – the 4-week period post intervention commencement

Secondary outcome [2]

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]

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]

University

Name [1]

The University of Newcastle

Address [1]

University Drive, Callaghan NSW 2308
Australia

Country [1]

Australia

Funding source category [2]

Government body

Name [2]

Hunter New England Population Health

Address [2]

Longworth Avenue, Wallsend NSW 2287
AUSTRALIA

Country [2]

Australia

Primary sponsor type

University

Name

The University of Newcastle

Address

University Drive, Callaghan NSW 2308
Australia

Country

Australia

Secondary sponsor category [1]

Government body

Name [1]

Hunter New England Population Health

Address [1]

Longworth Avenue, Wallsend NSW 2287
AUSTRALIA

Country [1]

Australia

Other collaborator category [1]

Commercial sector/Industry

Name [1]

Flexischools

Address [1]

5 Victoria Parade, Manly, NSW 2095
AUSTRALIA

Country [1]

Australia

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Hunter New England Human Research Ethics Committee

Ethics committee address [1]

HNE Research Support & Development Office
Locked Bag No. 1
NEW LAMBTON 
NSW  2305

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

18/04/2016

Approval date [1]

09/05/2016

Ethics approval number [1]

06/07/26/4.04

Summary

Brief summary

Evidence from paper-based menus suggests that the position of items within the menu influences the frequency with which items are purchased, with items positioned first and last on the menu purchased at up to double the rate of items in the centre of the menu. 
The current study aims to determine whether similar principles apply online within the online school canteen setting. A cluster randomised trial will be conducted which involves re-positioning target items within the online menu of the intervention group and determining the effect on sales of those items. It is hypothesised that a higher proportion of online lunch orders in intervention schools will contain the target items (fruit and vegetable snacks) relative to online lunch orders from control schools. 
Six schools that currently use an online lunch ordering system will be recruited to the trial. Three schools will be randomly allocated to receive the intervention by an independent statistician using a randomised number function in excel. Intervention schools will have their online lunch order menu reviewed by a dietitian, who will identify any fruit and vegetables snack items on the menu. These items will be moved from their current position, and grouped together in a single menu category called “Fruit & Veggie Snacks” and will appear as the first food category on the online menu, and will be repeated to form the last food category on the menu. The intervention will run for a 4-week period. 
The primary trial outcome is the proportion of online lunch orders in intervention schools that contain any target items (“Fruit & Veggie Snacks”). The online lunch ordering system automatically captures and records all sales made through the system. This data will be analysed to determine the impact of the re-positioning intervention in intervention schools relative to control schools. The 4-week period immediately prior to intervention commencement will form the baseline period.

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Dr Rebecca Wyse

Address

C/o Hunter New England Population Health
Locked Bag 10
WALLSEND NSW 2387

Country

Australia

Phone

+61 2 4924 6477

Fax

+61 2 4924 6490

rebecca.wyse@hnehealth.nsw.gov.au

Contact person for public queries

Name

Rebecca Wyse

Address

C/o Hunter New England Population Health
Locked Bag 10
WALLSEND NSW 2387

Country

Australia

Phone

+61 2 4924 6477

Fax

+61 2 4924 6490

rebecca.wyse@hnehealth.nsw.gov.au

Contact person for scientific queries

Name

Rebecca Wyse

Address

C/o Hunter New England Population Health
Locked Bag 10
WALLSEND NSW 2387

Country

Australia

Phone

+61 2 4924 6477

Fax

+61 2 4924 6490

rebecca.wyse@hnehealth.nsw.gov.au

Data sharing statement

Will individual participant data (IPD) for this trial be available (including data dictionaries)?

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.

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