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Trial registered on ANZCTR


Registration number
ACTRN12614000644662
Ethics application status
Approved
Date submitted
30/05/2014
Date registered
18/06/2014
Date last updated
24/08/2016
Type of registration
Prospectively registered

Titles & IDs
Public title
Effects of interpretive front-of-pack nutrition labels on food purchases: a randomised controlled trial
Scientific title
Effects of Traffic-Light and Health Star Rating front-of-pack nutrition labels, compared to standard Nutrition Information Panel label, on the mean nutrient profiling score of food purchases among the adult shoppers in New Zealand: a three-arm open-label parallel randomised controlled trial.
Secondary ID [1] 284702 0
None
Universal Trial Number (UTN)
Trial acronym
Starlight
Linked study record

Health condition
Health condition(s) or problem(s) studied:
nutrition labelling 292055 0
Condition category
Condition code
Diet and Nutrition 292394 292394 0 0
Other diet and nutrition disorders
Public Health 292468 292468 0 0
Health promotion/education

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Arm 1: Traffic-Light front-of-pack nutrition label. 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).
Arm 2: Health Star Rating front-of-pack nutrition label. 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.

Intervention details (for Arm 1 & 2):
Mode of administration: delivered via a specially designed smartphone application (app)
Duration of intervention: four weeks
Frequency: 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.
Strategies to improve adherence: Automated reminder messages via the smartphone app will appear three times per week to prompt the participants to use the app.
Intervention code [1] 289493 0
Lifestyle
Comparator / control treatment
Arm 3: Nutrition Information Panel (standard New Zealand nutrition label): numerical nutrition information presented in tabular format.

Control details:
Mode of administration: delivered via a specially designed smartphone application (app)
Duration of intervention: four weeks
Frequency: 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.
Strategies to improve adherence: Automated reminder messages via the smartphone app will appear three times per week to prompt the participants to use the app.
Control group
Active

Outcomes
Primary outcome [1] 292259 0
Mean nutrient profiling score for all food and beverage products purchased over the four-week intervention period. Nutrient profiling scores will be calculated using the Food Standards Australia New Zealand (FSANZ) nutrient profiling standard. Food purchases information is collected via electronic records (participants will scan barcodes of purchased items using the smartphone app. The app will automatically transmit the data to study database) and till receipts.
Timepoint [1] 292259 0
Mean over the 4 week intervention period
Secondary outcome [1] 308572 0
Difference between trial arms in mean saturated fat, total sugar, sodium and energy content per 100g packaged food purchases. Food purchases information will be obtained from electronic records (participants will scan barcodes of purchased items using the smartphone app. The app will automatically transmit the data to study database). Food composition data will be obtained from Nutritrack, a brand-specific processed food composition database that contains comprehensive annually-updated information on New Zealand packaged and fast foods.
Timepoint [1] 308572 0
Mean over the 4 week intervention period
Secondary outcome [2] 308573 0
Difference between trial arms in mean weekly food expenditure. Information on food expenditure will be obtained from till receipts collected by participants.
Timepoint [2] 308573 0
Mean over the 4 week intervention period
Secondary outcome [3] 308574 0
Labelling profile of food purchases (mean number of Health Star Rating stars and proportions of red, green and amber traffic lights)
Timepoint [3] 308574 0
Mean over the 4 week intervention period
Secondary outcome [4] 308575 0
Difference between trial arms in mean nutrient profiling score for all food and beverage products purchased each week of the intervention period
Timepoint [4] 308575 0
Week 1, Week 2, Week 3 and Week 4 of the intervention perion
Secondary outcome [5] 308576 0
Difference between trial arms in mean nutrient profiling score of key food categories likely to be most impacted by nutrition labelling (e.g. breakfast cereals, cereal bars, pizzas and ready meals)
Timepoint [5] 308576 0
Mean over the 4 week intervention period
Secondary outcome [6] 308577 0
Difference between trial arms in mean nutrient profiling score of the 3 nutrient profiling score criterion food categories (beverages, fats and oils, all other foods).
Timepoint [6] 308577 0
Mean over the 4 week intervention period
Secondary outcome [7] 308578 0
Difference between trial arms in mean purchases of unpackaged foods (e.g. fruit and vegetables) in g/100g. Information on unpackaged food purchases will be obtained from till receipts collected by participants.
Timepoint [7] 308578 0
Mean over the 4 week intervention period
Secondary outcome [8] 308579 0
Difference between trial arms in self-reported nutrition knowledge at follow-up. Self-reported nutrition knowledge will be assessed in baseline and follow-up questionnaires. The questionnaires were designed specifically for this study.
Timepoint [8] 308579 0
End of Week 4 of the intervention
Secondary outcome [9] 308580 0
Difference between trial arms in use of assigned labelling system as recorded by the smartphone app
Timepoint [9] 308580 0
Mean over the 4 week intervention period

Eligibility
Key inclusion criteria
1) Adults (n=1500), 18 years and older, currently living in NZ
2) Owners of a compatible smartphone (iPhone version 3 or later, or Android; models compatible with the application)
3) Shop at a supermarket at least once a week
4) Regular main shopper for the household (do at least 50% of shopping for the household every week)
5) Available for a continuous 5-week trial period
6) Ability to read and understand English
7) Ethnicity will be monitored to ensure equal recruitment of Maori, Pacific and Other ethnicities
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
1) Previously used the “FoodSwitch” application and/or have it downloaded on their phone
2) Planning to travel/be away for a prolonged time (more than 2 consecutive days) during the study intervention – those participants will be invited to join the study once they are back
3) Only one person per household may be enrolled in this study
4) Failure to successfully complete run-in phase

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)
Computer-generated blocked randomization
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint(s)
Statistical methods / analysis
The sample size estimated was based on difference between groups in mean NPSC score. With the assumption of a standard deviation (SD) of 9.9, which was the actual variance of NPSC scores in a similar Australian branded food composition database, a sample size of approximately 1500 individuals was estimated to provide 80% power at a 5% level of significance (two-sided) to detect a two-unit difference in mean NPSC score between either of the intervention arms and the control group, with adjustment for multiple comparisons.

Treatment evaluations will be performed on the principle of intention to treat, with randomised participants analysed according to the treatment to which they were assigned, regardless of whether they received the treatment or not. No imputation will be undertaken. For the primary outcome, analysis of covariance (ANCOVA) regression models will be used to compare intervention and control groups, adjusting for baseline NPSC, age, gender and ethnicity (Maori, Pacific, Other). A similar approach will be used for continuous secondary outcomes. Repeated measures mixed models will be used to evaluate treatment effects over time.

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 outside Australia
Country [1] 6086 0
New Zealand
State/province [1] 6086 0

Funding & Sponsors
Funding source category [1] 289326 0
Government body
Name [1] 289326 0
Health Research Council of New Zealand (ref: 13/724)
Address [1] 289326 0
Level 3 - ProCARE Building
Grafton Mews
at 110 Stanley Street
Auckland 1010
Country [1] 289326 0
New Zealand
Primary sponsor type
University
Name
National Institue for Health Innovation; University of Auckland
Address
National Institute for Health Innovation
School of Population Health
University of Auckland
Private bag 92019
Auckland Mail Centre 1142
Country
New Zealand
Secondary sponsor category [1] 288013 0
None
Name [1] 288013 0
Address [1] 288013 0
Country [1] 288013 0
Other collaborator category [1] 277984 0
Other
Name [1] 277984 0
The George Institute for Global Health
Address [1] 277984 0
Level 13, 321 Kent Street Sydney NSW, Australia 2000
Country [1] 277984 0
Australia
Other collaborator category [2] 277985 0
University
Name [2] 277985 0
British Heart Foundation Centre on Population Approaches for Non-Communicable Disease Prevention
University of Oxford
Address [2] 277985 0
British Heart Foundation Centre on Population Approaches for NCD Prevention

Nuffield Department of Population Health

University of Oxford

Old Road Campus

Oxford

OX3 7LF
Country [2] 277985 0
United Kingdom

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 291092 0
University of Auckland Human Participants Ethics Committee
Ethics committee address [1] 291092 0
Research Integrity Unit
Level 10, Building 620
49 Symonds Street
Auckland 1010
Ethics committee country [1] 291092 0
New Zealand
Date submitted for ethics approval [1] 291092 0
Approval date [1] 291092 0
26/05/2014
Ethics approval number [1] 291092 0

Summary
Brief summary
Governments throughout the world are considering implementing front-of-pack (FOP) nutrition labelling systems. FOP labels provide ‘at a glance’ information that is easy for consumers to understand and act upon. There is now substantial global evidence indicating that interpretative FOP labels (using graphics, symbols or colours) are better understood than traditional quantitative
nutrition labels (Campos et al., 2011). However, research on the impact of FOP labels on food purchases and consumption is greatly needed (Signal et
al., 2012).
The aim of this study is to assess the effects of two interpretive FOP nutrition labels, compared with a standard non-interpretive numerical label, on the healthiness of consumer food purchases in supermarkets and other retail outlets in New Zealand.
In this study, two types of FOP labels (Traffic Lights (TL) and Health Star Rating) are compared with a nutrition information panel, which is a current mandatory labelling standard in New Zealand. Several studies suggest that the TL is the best understood FOP label (Signal et al., 2012; Hawley et al., 2013). Health Star Rating labelling will be introduced as a voluntary FOP labelling in Australia.
Because it is impossible to apply the front-of-pack labels to be tested to actual food products in supermarkets and other stores, all labels to be tested in the trial will be delivered via download of a smartphone application. The application will be active during the 4 weeks of the study intervention only.
The application will be used in the following way:
(1) Participants open the application on their smartphone;
(2) They position the smartphone camera over the barcode of a packaged food product;
(3) The camera acquires the barcode image and immediately provides the product’s nutrition information in one of the following onscreen label formats:
Traffic Light Label, Health Star Rating Label or Nutrition Information Panel.
Trial website
https://diet.auckland.ac.nz/content/starlight-page
Trial related presentations / publications
Volkova E, Neal B, Rayner M, Swinburn BA, Eyles H, Jiang Y, Michie J, Ni Mhurchu C. Effects of interpretive front-of-pack nutrition labels on food purchases: protocol for the Starlight randomised controlled trial. BMC Public Health 2014; 14:968

Volkova E, Li N, Dunford E, Eyles H, Crino M, Michie J, Ni Mhurchu C. “Smart” RCTs: development of a smartphone app for fully automated nutrition-labeling intervention trials. JMIR mHealth uHealth 2016; 4(1): e23
Public notes

Contacts
Principal investigator
Name 48842 0
Prof Cliona Ni Mhurchu
Address 48842 0
National Institute for Health Innovation
University of Auckland
Private Bag 92019
Auckland Mail Centre 1142
Auckland
New Zealand
Country 48842 0
New Zealand
Phone 48842 0
64 9 3737599 ext. 84494
Fax 48842 0
Email 48842 0
enquiries@nihi.auckland.ac.nz
Contact person for public queries
Name 48843 0
Prof Cliona Ni Mhurchu
Address 48843 0
National Institute for Health Innovation
University of Auckland
Private Bag 92019
Auckland Mail Centre 1142
Auckland
New Zealand
Country 48843 0
New Zealand
Phone 48843 0
+64 9 923 4494
Fax 48843 0
Email 48843 0
enquiries@nihi.auckland.ac.nz
Contact person for scientific queries
Name 48844 0
Prof Cliona Ni Mhurchu
Address 48844 0
National Institute for Health Innovation
University of Auckland
Private Bag 92019
Auckland Mail Centre 1142
Auckland
New Zealand
Country 48844 0
New Zealand
Phone 48844 0
64 9 3737599 ext. 84494
Fax 48844 0
Email 48844 0
enquiries@nihi.auckland.ac.nz

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