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Trial registered on ANZCTR


Registration number
ACTRN12620001016921
Ethics application status
Approved
Date submitted
7/09/2020
Date registered
7/10/2020
Date last updated
9/12/2022
Date data sharing statement initially provided
7/10/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
Exploring the effectiveness of policy options for simultaneous displaying multiple added sugar labels in Australian adults
Scientific title
Exploring the effectiveness of policy options for simultaneously displaying multiple added sugar labels on purchasing behaviour in Australian adults
Secondary ID [1] 301944 0
NIL
Universal Trial Number (UTN)
Trial acronym
Linked study record
This study is linked to a previous trial. ACTRN12620000858998 was an RCT evaluating the relative effectiveness of proposed added sugar labels (n = 7) to facilitate healthier choices by consumers.

Health condition
Health condition(s) or problem(s) studied:
Promotion of healthy diet choices 318492 0
Obesity 318959 0
Condition category
Condition code
Public Health 316495 316495 0 0
Other public health
Public Health 316496 316496 0 0
Health promotion/education
Diet and Nutrition 316497 316497 0 0
Obesity

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Interventional
We will examine (i) the relative effect of different combinations of added sugar labels on food and beverage purchasing (using the two most effective labels from a previous trial [Trial 1ACTRN12620000858998]); and (ii) effects by level of participant sugar consumption, gender, age, education, and income. This new evidence will guide and inform the development of effective labelling policies to reduce added sugar consumption for Australians and New Zealanders.

Trial:
A third-party recruitment company will be used to recruit participants for the online study. The recruitment company have security measures in place to securely store participants’ identifiable data. No identifiable information will be received by the researchers from the recruitment company. Research data (i.e. answers to the survey) will not be available to or stored by the recruitment company.
Eligible participants will be randomised to complete one of four online survey conditions that will take approximately 10-15 minutes to complete.
Participants will be screened in order to classify them as high or low sugar purchasers. Participants will be asked to select all relevant products they purchase at least once a month for themselves or their household from a range of generic product subcategories in each of the product categories of interest (yoghurt and custards, breakfast cereal and non-alcoholic packaged drinks). For example, in the yoghurt categories this will include: plain Greek or natural yoghurt, flavoured Greek or natural yoghurt, custard etc. These generic subcategories will be classified as “high” and “low” sugar products. If the participants select one or more high sugar products in each category they will be considered a high sugar purchaser.

Participants will select their gender, age, education level and income from study specific question groupings.

Each survey condition will include three hypothetical purchasing tasks: one each for breakfast cereals, yoghurts and non-alcoholic packaged beverages. The products in each hypothetical purchasing scenario are commercially available and products that participants would recognise.
In the current trial, the two most effective labels from Trial 1 (ACTRN12620000858998) will be used to determine four test scenarios for the Trial 2 (current trial). The four test scenarios will be: (i) Status quo – current Nutrition Information Panel (NIP) (Back of Pack labelling system without added sugar content) (control condition); (ii) Label A; (iii) Label B; and (iv) Label A and Label B shown simultaneously. Each participant will be exposed to one treatment condition (sugar labelling intervention or control) and complete the purchasing task in all three food categories. Participants will not receive any feedback after completing the survey. Please refer to trial record ACTRN12620000858998 for further details regarding the different labels assessed in the first study
Intervention code [1] 318232 0
Behaviour
Intervention code [2] 318233 0
Prevention
Comparator / control treatment
Participants exposed to (i) Status quo – current Nutrition Information Panel (NIP) (Back of Pack labelling system without added sugar content)
Control group
Active

Outcomes
Primary outcome [1] 324641 0
The proportion of high sugar products purchased will be assessed using study specific hypothetical food purchasing task questions. “High” sugar products will be classified using the UK Nutrient Profiling Model (foods >6.25g added sugar/100g and beverages >3.13g/100ml). Purchases of high sugar products will be compared between labelling conditions for each food category.
Timepoint [1] 324641 0
Immediately after being exposed to the study intervention
Secondary outcome [1] 385306 0
The mean added sugar content of purchases (g/100g) will be assessed using study-specific hypothetical food purchasing task questions.
To calculate added sugar of products we will use the following decision tree: i) if the ingredients list includes added/free sugars only then the total sugars will be considered added sugars; ii) if the ingredients list includes a mixture of added sugars and intrinsic sugars then we will allocate added sugar as a percentage of total sugar content, based on the percentage added sugar content of a similar generic product in AUSNUT database. We will use AUSNUT “free sugars” content to calculate this. For water-based beverages we will assume that all sugars are added sugars. For fruit juices, we will select branded drinks that provide the percentage of juice the product so we can calculate added sugar content.
Purchases will be compared between labelling conditions for each food category.
Timepoint [1] 385306 0
Immediately after being exposed to the study intervention
Secondary outcome [2] 385307 0
The mean Health Star Rating (from 0.5 to 5) of purchases, will be assessed using study-specific hypothetical food purchasing task questions. Health Star Rating will be derived using modifications to the publicly available calculator of the HSR algorithm. To calculate the modified Health Star Rating including added sugar, we will use the UK Nutrient Profiling Model scale for 10% added sugar intake. Purchases will be compared between labelling conditions for each food category.
Timepoint [2] 385307 0
Immediately after being exposed to the study intervention
Secondary outcome [3] 385308 0
The proportion of Five Food Group (healthy) and discretionary (unhealthy) foods purchased will be assessed using study-specific hypothetical food purchasing task according to Australian Dietary Guidelines. Purchases will be compared between labelling conditions for each food category.
Timepoint [3] 385308 0
Immediately after being exposed to the study intervention

Eligibility
Key inclusion criteria
-Australian residents
-18 years or older
-Access to a computer and internet connection to complete the survey
-Regular (at least once a month or more) purchasers of breakfast cereal, yoghurt and non- alcoholic pre-packaged drinks for themselves or their household
-Completes at least one supermarket shop per month for their household
-Lives with at least one child <18 years

We will also apply the following recruitment quota:
-At least 50% of participants will be considered high sugar purchases. To categorise participants into high sugar purchasers and low sugar purchasers they will be asked to indicate whether they purchase at least once a month for themselves or their household high sugar yoghurt, breakfast cereal and non-alcoholic packaged drinks (e.g. flavoured yoghurts, kids cereals). If the participants select one or more high sugar products in each category, they will be considered a high sugar consumer
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Participants included in Trial 1 (ACTRN12620000858998).

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)
Eligible participants who agree to participate will be randomised to one of four treatment groups. The treatment, order of tasks, and order of alternatives presented in each task, will all be randomised.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Participants will not be allocated to intervention groups based on current purchasing habits. Current purchasing habits will be used to determine overall sample composition only. After screening, simple randomisation will occur via the online survey platform to one of the four treatment groups.
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
Primary outcome:
The differences in the proportion of high sugar products among intended purchases across treatment groups which will be examined using logistic regression analyses. “High” sugar products will be classified using the UK Nutrient Profiling Model (foods >6.25g added sugar/100g and beverages >3.13g/100ml).

Secondary outcomes:
The differences between treatment groups in overall intended purchases by (i) added sugar content (g/100g); (ii) Health Star Rating (from 0.5 to 5); and (iii) percentage of Five Food Group (healthy) and discretionary (unhealthy) foods according to Australian Dietary Guidelines, which will be analysed using logistic or linear regression, as appropriate. We will then test for interaction with possible effect modifiers, including gender, age, education, and usual sugar consumption, and stratify analyses when an interaction term is significant at a p-value of <0.01. All analyses will be adjusted for key covariates.

Recruitment
Recruitment status
Withdrawn
Reason for early stopping/withdrawal
Lack of funding/staff/facilities
Date of first participant enrolment
Anticipated
2/11/2020
Actual
Date of last participant enrolment
Anticipated
16/11/2020
Actual
Date of last data collection
Anticipated
23/11/2020
Actual
Sample size
Target
1152
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 306360 0
University
Name [1] 306360 0
Deakin University
Country [1] 306360 0
Australia
Primary sponsor type
Individual
Name
Miranda R Blake
Address
Deakin University
Faculty of Health
221 Burwood Hwy,
Burwood VIC 3125
Country
Australia
Secondary sponsor category [1] 306871 0
None
Name [1] 306871 0
Address [1] 306871 0
Country [1] 306871 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 306568 0
The Deakin University Human Research Ethics Committee (DUHREC)
Ethics committee address [1] 306568 0
Ethics committee country [1] 306568 0
Australia
Date submitted for ethics approval [1] 306568 0
27/05/2020
Approval date [1] 306568 0
06/07/2020
Ethics approval number [1] 306568 0
HEAG-H 115_2020

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

Contacts
Principal investigator
Name 104314 0
Dr Miranda R Blake
Address 104314 0
Deakin University
Faculty of Health
221 Burwood Hwy
Burwood, VIC 3125
Country 104314 0
Australia
Phone 104314 0
+613 924 68487
Fax 104314 0
Email 104314 0
miranda.blake@deakin.edu.au
Contact person for public queries
Name 104315 0
Miranda R Blake
Address 104315 0
Deakin University
Faculty of Health
221 Burwood Hwy
Burwood, VIC 3125
Country 104315 0
Australia
Phone 104315 0
+613 924 68487
Fax 104315 0
Email 104315 0
miranda.blake@deakin.edu.au
Contact person for scientific queries
Name 104316 0
Miranda R Blake
Address 104316 0
Deakin University
Faculty of Health
221 Burwood Hwy
Burwood, VIC 3125
Country 104316 0
Australia
Phone 104316 0
+613 924 68487
Fax 104316 0
Email 104316 0
miranda.blake@deakin.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
All of the individual de-identified participant data collected during the trial may be shared with other researchers and re-used for further research relating to food retail research, beyond the current research project specified.
When will data be available (start and end dates)?
The data will be available for at least 5 years from the date of final publication of results (likely 2021 to 2026).
Available to whom?
The research team and other researchers requesting the data.
Available for what types of analyses?
The data may be used for further analysis that is related to food retail research, beyond the current research project specified.
How or where can data be obtained?
The data will be made available to other researchers upon request and at the discretion of the research team if they deem it relevant to food retail research. The interested party will be required to contact the principal investigator via email (miranda.blake@deakin.edu.au) or phone (+61 3 924 68487) in order to obtain the data.


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.