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Trial registered on ANZCTR


Registration number
ACTRN12614000964617
Ethics application status
Approved
Date submitted
21/08/2014
Date registered
9/09/2014
Date last updated
15/07/2016
Type of registration
Prospectively registered

Titles & IDs
Public title
The effects of four front-of-pack labelling schemes compared to standard Nutrition Information Panel, on the healthiness of food Purchases among adult Australian consumers.
Scientific title
The effects of four front-of-pack labelling schemes compared to standard Nutrition Information Panel, on mean nutrient profiling score of food purchases among the adult Australian consumers: A Randomised Trial
Secondary ID [1] 285204 0
None
Universal Trial Number (UTN)
U1111-1160-6869
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
food health 292820 0
Condition category
Condition code
Diet and Nutrition 293112 293112 0 0
Other diet and nutrition disorders
Public Health 293113 293113 0 0
Other public health
Cardiovascular 293114 293114 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The study intervention include four different front of pack nutrition labelling schemes that will be shown to study participants via a smartphone application. The study intervention duration is four-week.

The labelling schemes that will be tested in the study are:
*Colour-coded multiple traffic-light labels (the current public health gold standard). Traffic-light label uses green, amber and red colours to indicate the relative levels (low, medium and high) of four nutrients (fat, saturated fat, sugar and sodium).

*Monochrome daily intake guide labels (the current food industry option). This label provides information on the level of energy, fat, saturated fat, sugar and sodium per serve and the percentage of each on the average Australian daily intake.

*The ‘energy stars’ based front-of-pack nutrition label format selected by the Federal Government. The label assigns a rating from 0.5 (less healthy) to 5 (most healthy) stars to foods basing on their Health Star Rating score, calculated from energy, fat, sugar and salt content, and adjusted for other components, such as fruit and vegetables.

*Advisory labels that warn against the purchase of less healthy products and encourage the purchase of more healthy products. In addition to information available on the standard nutrition information panel, this standard label will provide a green sign indicatig a food being a healthy choice or a red sign indicating the food being unhealthy and suggesting consumer to avoid. The warning signs are calculated basd on the food nutrition profile score in each category.

participants will be able to use the smartphone app to view nutrition labels as often as they wish. To view a nutrition label, users scan barcodes of packaged food products using the smartphone camera, and assigned labels instantly appear on the phone screen.

Automated reminder messages via the smartphone app will appear three times per week on their smartphone screen to prompt the participants to use the app.
Intervention code [1] 290076 0
Behaviour
Intervention code [2] 290077 0
Lifestyle
Intervention code [3] 290078 0
Prevention
Comparator / control treatment
The control group will be shown the nutrition information panel that is currently available on the back of all food packages in Australia. The control treatment will be provided using the same mode, frequency as the intervention treatment using the smart phone app.
Control group
Active

Outcomes
Primary outcome [1] 292981 0
Healthiness of food purchases as evaluated by the mean nutrient profile score of all food and beverage products purchased over the four-week intervention period. Mean nutrient profiling score will be calculated using the Food Standards Australia New Zealand (FSANZ) nutrient profiling standard. Food purchase information is collected via electronic records (participants will be asked to scan barcodes of purchased items and take photos of the till receipts using the smartphone app and send to the study investigators. The app will then transmit the data to study database. Participants will also be asked to send in the hardcopies of their till receipts in a reply-paid envelop provided by the study. Food purchase information will later be collated from both electronic and paper sources for analysis.
Timepoint [1] 292981 0
Data collected during the four weeks post randomisation
Secondary outcome [1] 310067 0
mean concentrations of total fat, saturated fat, sugar, salt and energy of food purchased during the 4-week study period. Food purchase information is collected using the smartphone app as described in the primary outcome section. Nutrient information of food purchased will be obtained from te Australian processed food composition database that contains comprehensive annually-updated information on Australian packaged and fast foods.
Timepoint [1] 310067 0
Data collected during the four weeks of study period post randomisation.
Secondary outcome [2] 310068 0
consumer understanding and use of the assigned front-of-pack labelling system. This information is collected at the completion of the intervention period through a questionnaire built in the smartphone app. Participants will be asked to provide their answers on the 10 point Likert Scale.
Timepoint [2] 310068 0
Data collected at the end of the 4-week study period
Secondary outcome [3] 310069 0
Consumer overall perception of the assigned front-of-pack labelling scheme. This information will be collected using a structured telephone interview questionnaire specifically designed for this purpose.
Timepoint [3] 310069 0
Collected through a subset of participants within 6 months after the overall study is completed
Secondary outcome [4] 310353 0
weekly food expenditure. Information on food expenditure will be obtained from till receipts sent in by participants.
Timepoint [4] 310353 0
Data collected during the four weeks of the study period post randomisation

Eligibility
Key inclusion criteria
1.Can read and understand English
2.Have a compatible smartphone (iPhone with iOS 7 or Android device with OS versions 4.3 or 4.4)
3.Are the main shopper of the household (do at least 50% of household shopping)
4.Shop at a supermarket at least once a week
5.Are 18 years or over
6.Provide informed consent
7.Do not plan to be away during the 5 week study period
8. Have never used FoodSwitch
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Past or current user of FoodSwitch smartphone app

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)
Once a participant completes the one week run-in period of the study, they will be randomised at the backend of the smartphone app. Participants will be randomised according to the blocked randomisation list generated by a statistician. Only the person who is directly responsible for programming the randomisation list at the smartphone app developer company will have access to this list. Neither the study investigator nor the study participant has any way to find out the treatment allocation before and during the study.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Participants will be randomized using blocked randomization. Blocking is used to ensure that comparison groups will be generated according to the predetermined ratio of 1:1:1:1:1. Blocking can be used to ensure close balance of the numbers in each group at any time during the trial. The sequence of group allocation within each block will be at random.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?

The people administering the treatment/s

The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis
The goal is to have power to detect small effects even after allowing for multiplicity adjustments. With a sample size of 2500 randomised individuals, assigned in a 1:1:1:1:1 ratio to one of the four intervention groups or control, the study will have 90% power (at alpha=0.05) to detect a 2 unit or greater difference in the mean nutrient profile of purchased foods (healthiness score derived from the FSANZ nutrient profile system) between the specified pairs of groups. The power estimate assumes a standard deviation of 9.9 of the nutrient profile score, which is the statistic obtained from the foods included in the Australian branded food composition database. Power for the primary analysis has been calculated conservatively assuming data from a single shopping episode will be available from each randomized participant. It is, however, anticipated that multiple shopping episodes will be submitted by most participants and this will increase the study power through the use of mixed models.

The baseline characteristics will be summarised and tabulated with means (and ranges) and proportions presented for comparison. Estimation of the effects of each intervention will be done according to the principle of intention to treat with the mean nutrient profile (food healthiness) scores compared between the groups. Comparisons between the effects of the interventions will be made using mixed models that are able to incorporate data from the multiple shopping episodes that will be reported by most participants. A p-value of 0.05 or less will be deemed to indicate a significant finding with the significance level maintained at 0.05 using a Bonferoni correction to control for the four primary comparisons that will be made between the ‘energy stars’ format, each alternative labelling strategy and control. A series of subgroup analyses will be undertaken to explore possible modifying effects of factors such as age, gender, socio-economic group and baseline understanding of front-of-pack labels.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 289821 0
Government body
Name [1] 289821 0
The National Health and Medical Research Council of Australia
Address [1] 289821 0
Level 1
16 Marcus Clarke Street
Canberra ACT 2601
Country [1] 289821 0
Australia
Primary sponsor type
Other
Name
The George Institute for Global Health
Address
Level 10, King George V Building, Royal Prince Alfred Hospital, Missenden Rd
Camperdown NSW 2050 Australia
Country
Australia
Secondary sponsor category [1] 288512 0
Commercial sector/Industry
Name [1] 288512 0
Bupa Australia
Address [1] 288512 0
Level 19, 201 Kent street. Sydney, NSW, 2000. Australia.
Country [1] 288512 0
Australia
Secondary sponsor category [2] 288513 0
Charities/Societies/Foundations
Name [2] 288513 0
National Heart Foundation of Australia
Address [2] 288513 0
Unit 1, Level 1, 17-23 Townshend Street
Phillip ACT 2606
Country [2] 288513 0
Australia
Other collaborator category [1] 278122 0
Individual
Name [1] 278122 0
Simone Pettigrew
Address [1] 278122 0
School of Psychology and Speech Pathology, Level 2 Building 400, Kent Street, Bentley Campus, Curtin University, WA 6102, Australia
Country [1] 278122 0
Australia
Other collaborator category [2] 278123 0
Individual
Name [2] 278123 0
Gary Sacks
Address [2] 278123 0
Faculty of Health, Melbourne Burwood Campus, Deakin University, 221 Burwood Hwy, Burwood, Victoria 3125 Australia
Country [2] 278123 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 291551 0
The University of Sydney Human Research Ethics Committee
Ethics committee address [1] 291551 0
Office of Research Integrity
Research Portfolio
THE UNIVERSITY OF SYDNEY
Lv 2, Margaret Telfer Building (K07), The University of Sydney NSW2006
Ethics committee country [1] 291551 0
Australia
Date submitted for ethics approval [1] 291551 0
18/08/2014
Approval date [1] 291551 0
25/08/2014
Ethics approval number [1] 291551 0
2014/460

Summary
Brief summary
A large scale randomised controlled trial conducted using a smartphone application to evaluate the comparative effects of four different forms of front-of-pack nutrition labelling against the current back-of-pack nutrition information panel on the healthiness of foods purchased. The four front-of-pack nutrition labelling formats tested will be: 1. Colour-coded multiple traffic-light labels; 2. Monochrome daily intake guide labels; 3. The "energy stars" based front-of-pack nutrition labels; and 4. Advisory labels. The findings will feed directly into the ongoing policy debate about the format of front-of-pack nutrition labelling to be introduced in Australia.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 50838 0
Prof Bruce Neal
Address 50838 0
The George Insitute for Global Health,
Level 10, King George V Building, 83-117 Missenden Rd, Camperdown NSW 2050 Australia
Country 50838 0
Australia
Phone 50838 0
+61 2 9993 4558
Fax 50838 0
Email 50838 0
bneal@georgeinstitute.org.au
Contact person for public queries
Name 50839 0
Dr Nicole Li
Address 50839 0
The George Insitute for Global Health,
Level 10, King George V Building, 83-117 Missenden Rd, Camperdown NSW 2050 Australia
Country 50839 0
Australia
Phone 50839 0
+61 2 9993 4507
Fax 50839 0
Email 50839 0
nli@georgeinstitute.org.au
Contact person for scientific queries
Name 50840 0
Dr Nicole Li
Address 50840 0
The George Insitute for Global Health,
Level 10, King George V Building, 83-117 Missenden Rd, Camperdown NSW 2050 Australia
Country 50840 0
Australia
Phone 50840 0
+61 2 9993 4507
Fax 50840 0
Email 50840 0
nli@georgeinstitute.org.au

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary