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Trial registered on ANZCTR


Registration number
ACTRN12618000855224
Ethics application status
Approved
Date submitted
17/05/2018
Date registered
22/05/2018
Date last updated
25/03/2021
Date data sharing statement initially provided
6/11/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
A cluster randomised controlled trial of a consumer behaviour intervention to reduce the average energy, saturated fat, sugar and sodium content of the online canteen lunch orders of primary school students: The 'Click & Crunch' Trial.
Scientific title
The effectiveness of a consumer behaviour intervention delivered via an online canteen ordering system in reducing the average energy, saturated fat, sugar and sodium content of primary school students' lunch orders: The 'Click & Crunch' cluster randomised controlled trial.
Secondary ID [1] 294851 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Poor diet 307798 0
Condition category
Condition code
Diet and Nutrition 306845 306845 0 0
Obesity
Public Health 306846 306846 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 such as menu labelling, item positioning, feedback, incentives, prompts, and price into an online canteen ordering system to reduce the average energy, saturated fat, sugar and sodium content of student lunch orders. The study will employ a clustered randomised trial design. Sixty two NSW primary schools with an existing online canteen ordering system will be randomised to receive either a consumer behaviour intervention or control (online canteen ordering only). The effectiveness of the intervention will be determined by comparing between-group differences at follow-up in the average i) energy (kilojoules), ii) saturated fat (grams) iii) sugar (grams), and iv) sodium (milligrams) content of students' online lunch orders using purchasing data automatically collected by the online canteen system. Outcome data will be assessed at baseline and 12-month follow-up. Assessment periods will be conducted over one school term (approximately 10 weeks).

All users (i.e. parents and students) 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. 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. The online canteen provider will modify the display of the online ordering system to incorporate the consumer behaviour strategies. For intervention schools, the provider will reprogram the website to automatically apply the strategies (where possible) to online menus, and then the research team will access the online menu for each intervention school to manually apply the remaining strategies. All strategies will be implemented on the mobile site of the online ordering system. The intervention will consist of the following evidence based strategies previously associated with healthy food purchases in analogous settings:

1. Labelling: Each item on the online menu will be labelled. The labelling system is based on the NSW Healthy School Canteen Strategy (e.g. ‘Everyday’, 'Occasional'). Canteen managers will also receive a hard-copy report of their labelled menu.

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 & last, with the least healthy in the centre. 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 graphical feedback summarising the nutritional content of the lunch order.

4. Incentives: A healthy lunch award symbol will be printed on the lunch bag label if the order contains 100% 'Everyday' items (excluding sauces, condiments, all non-food items). Symbols will rotate every week within each term

5. Prompts: Prompts will appear on the online menu including messages, images and descriptions specifically designed to encourage healthy purchasing. Prompts will also include healthy add-ons for ‘Occasional’ hot food items. For example, if users select an 'Occasional' hot food item for lunch then they will be prompted to purchase healthy add-ons (e.g. water and/or carrot sticks).

6. Pricing: Price is a key driver of consumer choice. While the pricing of menu items will be at the discretion of each school, canteen managers will receive a report summarising the average costs of 'Everyday' and 'Occasional' items across their menu and will receive information about how to competitively price ‘Everyday’ foods whilst maintaining canteen profitability.


Observations: Information collected from the online ordering system will undergo independent verification to ensure the integrity of data that is supplied by the provider. Specifically, in a random sample of 20% of participating schools, research assistants will visit the school canteen on one day and record all of the foods and drinks available for purchase, and all items ordered through the online ordering system. This information will be collected from the lunch order labels, as generated by the online system and cross-referenced with the purchasing data supplied by the provider. Schools will be asked to nominate a day that is convenient for them.

Child level data including child grade will be collected from the online ordering system. School level data including size (number of enrolments) and sector (Government, Catholic or Independent), year range (e.g. K-6), and school location (metropolitan, provincial, remote and very remote) will be collected from the ‘My School’ website. After the collection of follow up purchasing data, the Canteen Managers of schools allocated to the intervention will be contacted to take part in a computer assisted telephone interview (CATI) to assess the acceptability of intervention strategies and processes. Menu composition and analytics data (e.g. frequency of use, device used to place order, time taken to place the order) from the online ordering system will also be collected for descriptive purposes.
Intervention code [1] 301162 0
Prevention
Intervention code [2] 301163 0
Behaviour
Intervention code [3] 301164 0
Lifestyle
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] 305837 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 through the mobile site.
Timepoint [1] 305837 0
Baseline, 12-month and 18 month follow-up data will be conducted over one school term each (approximately 10 weeks).
Primary outcome [2] 305838 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 through the mobile site.
Timepoint [2] 305838 0
Baseline, 12-month and 18 month follow-up data will be conducted over one school term each (approximately 10 weeks).
Primary outcome [3] 305839 0
Primary Outcome 3: 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] 305839 0
Baseline, 12-month and 18 month follow-up data will be conducted over one school term each (approximately 10 weeks).
Secondary outcome [1] 346715 0
Primary Outcome 4: 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 [1] 346715 0
Baseline, 12-month and 18 month follow-up data will be conducted over one school term each (approximately 10 weeks).
Secondary outcome [2] 346716 0
Secondary Outcome 1: Canteen revenue - Purchasing data automatically collected by the online system through the mobile site will be used to calculate revenue.
Timepoint [2] 346716 0
Baseline, 12-month and 18 month follow-up data will be conducted over one school term each (approximately 10 weeks).
Secondary outcome [3] 346719 0
Secondary Outcome 2: The proportion per student, of all online lunch order items purchased that are ‘Everyday’ based on nutritional assessment of purchasing data automatically collected by the online ordering system through the mobile site.
Timepoint [3] 346719 0
Baseline, 12-months and-18 months follow-up data will be conducted over one school term each (approximately 10 weeks).
Secondary outcome [4] 347004 0
Secondary Outcome 3: The proportion per student, of all online lunch order items purchased that are ‘Occasional’ based on nutritional assessment of purchasing data automatically collected by the online ordering system through the mobile site.
Timepoint [4] 347004 0
Baseline, 12-months and-18 months follow-up data will be conducted over one school term each (approximately 10 weeks).
Secondary outcome [5] 376613 0
Secondary Outcome 4: The proportion per student, of all online lunch order items purchased that are ‘Should Not Be Sold' based on nutritional assessment of purchasing data automatically collected by the online ordering system through the mobile site.
Timepoint [5] 376613 0
Baseline, 12-month and 18-month follow-up data will be conducted over one school term each (approximately 10 weeks).
Secondary outcome [6] 376614 0
Secondary Outcome 5: Intervention effect over time. Explore the trajectory of the intervention effect over the course of the 9-month intervention period. This will be based on nutritional assessment of purchasing data automatically collected by the online ordering system through the mobile site.
Timepoint [6] 376614 0
Baseline and 12-month follow-up data will be conducted over one school term each (approximately 10 weeks).
Secondary outcome [7] 376615 0
Secondary outcome 6: The intervention cost, cost consequence and cost-effectiveness of the intervention.
Timepoint [7] 376615 0
Cost data will be collected using a specifically designed template throughout the duration of the intervention, supported by detailed project management records

Eligibility
Key inclusion criteria
1. NSW 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.

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)
Block randomisation will be employed to ensure group allocation is approximately equal. The procedure will be stratified by socioeconomic status of a school locality (given evidence that locality may be an important prognostic factor).
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Not applicable
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
28/05/2018
Actual
23/05/2018
Date of last participant enrolment
Anticipated
Actual
6/09/2018
Date of last data collection
Anticipated
1/07/2020
Actual
20/12/2019
Sample size
Target
13950
Accrual to date
Final
15000
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 299443 0
Government body
Name [1] 299443 0
National Health and Medical Research Council (NHMRC)
Country [1] 299443 0
Australia
Primary sponsor type
Government body
Name
National Health and Medical Research Council (NHMRC)
Address
Research Committee Secretariat NHMRC
GPO Box 1421 Canberra ACT 2601
Country
Australia
Secondary sponsor category [1] 298738 0
None
Name [1] 298738 0
Address [1] 298738 0
Country [1] 298738 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 300347 0
The University of Newcastle Human Research Ethics Committee (HREC)
Ethics committee address [1] 300347 0
Ethics committee country [1] 300347 0
Australia
Date submitted for ethics approval [1] 300347 0
30/11/2017
Approval date [1] 300347 0
22/03/2018
Ethics approval number [1] 300347 0
H-2017-0402

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

Contacts
Principal investigator
Name 83358 0
A/Prof Luke Wolfenden
Address 83358 0
C/o Hunter New England Population Health
Locked Bag 10,
WALLSEND, NSW 2287
Country 83358 0
Australia
Phone 83358 0
+61 02 492 45674
Fax 83358 0
Email 83358 0
Luke.Wolfenden@newcastle.edu.au
Contact person for public queries
Name 83359 0
Rebecca Wyse
Address 83359 0
C/o Hunter New England Population Health
Locked Bag 10,
WALLSEND, NSW 2287
Country 83359 0
Australia
Phone 83359 0
+61 02 4924 6510
Fax 83359 0
Email 83359 0
rebecca.wyse@hnehealth.nsw.gov.au
Contact person for scientific queries
Name 83360 0
Rebecca Wyse
Address 83360 0
C/o Hunter New England Population Health
Locked Bag 10,
WALLSEND, NSW 2287
Country 83360 0
Australia
Phone 83360 0
+61 02 4924 6510
Fax 83360 0
Email 83360 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
SourceTitleYear of PublicationDOI
EmbaseEffectiveness of a multistrategy behavioral intervention to increase the nutritional quality of primary school students'web-based canteen lunch orders (click & crunch): Cluster randomized controlled trial.2021https://dx.doi.org/10.2196/26054
EmbaseLong-term Effectiveness of a Multistrategy Behavioral Intervention to Increase the Nutritional Quality of Primary School Students' Online Lunch Orders: 18-Month Follow-up of the Click & Crunch Cluster Randomized Controlled Trial.2021https://dx.doi.org/10.2196/31734
N.B. These documents automatically identified may not have been verified by the study sponsor.