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Trial registered on ANZCTR


Registration number
ACTRN12624000529549
Ethics application status
Approved
Date submitted
2/04/2024
Date registered
29/04/2024
Date last updated
29/04/2024
Date data sharing statement initially provided
29/04/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
WARNING! Study - Developing and Testing Alcohol Warning Labels in adult New Zealanders who purchase and consume alcohol.
Scientific title
WARNING! Study - Developing and Testing Alcohol Warning Labels in adult New Zealanders who purchase and consume alcohol.
Secondary ID [1] 309643 0
N/A
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Alcohol-related harms 329972 0
Condition category
Condition code
Public Health 326881 326881 0 0
Health promotion/education

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This trial is the third stage of a mixed-method study (Stage 1: focus groups (July 2022) ; Stage 2: online cross-sectional survey (June 2023); Stage 3: four-arm parallel group, randomized controlled trial (April/May 2024) undertaken online).

For the trial, participants are recruited through a third-party market research company (Dynata and partners) and are screened and invited by email to take a web-based survey hosted by Dynata, which should take no longer than 10 minutes.

Three different warning labels have been developed based on findings from Stages 1 and 2, stakeholder feedback and published research. These labels relate to liver cancer, violence, and heart attack/stroke, and utilise both a pictogram/image with text.

After screening, eligible participants will be asked to provide baseline data via the online platform. Participants will then be randomly allocated (1:1:1:1 ratio) within the Dynata platform to view an image of an alcoholic drink (based on their response to a ‘drink of choice’ question (i.e. Beer, Wine, Spirits or ready-to-drink alcohol beverage [RTD]), with one of the three test warning labels, or no warning label (control) shown on the product, as described below.

Arm 1: Alcohol Warning Label 1 - (Liver Cancer)
Arm 2: Alcohol Warning Label 2 - (Violence)
Arm 3: Alcohol Warning Label 3 - (Heart/Stroke)
Arm 4: No label, control

Participants will then answer a series of questions about the images they view. The warning labels will be shown on the alcoholic drink as well as beside the product. All products will display the mandatory pregnancy warning label and the standard drinks label. Participants will have the choice to view the text of the test warning labels in English only, or both English and Te Reo Maori. The images of the alcoholic drinks are fictitious brands.

Dynata uses screening tools (QualityScore) to captures key data and tests behavioral elements as well as passive elements (mouse movement, speed, copy and pasting) to assign a quality score before respondents touch a survey. Scores below 20 are removed from the panel immediately.
Intervention code [1] 326071 0
Lifestyle
Comparator / control treatment
'No-warning label', control arm, using images of alcoholic drinks (Beer, Wine, Spirits or RTD) including the mandated pregnancy warning label and the standard drinks label.
Control group
Active

Outcomes
Primary outcome [1] 334725 0
Participants will be asked their likely intent to purchase and consume the alcoholic drink (image shown), based on an 11-point Juster probability scale, where zero represents ‘not likely at all to purchase and drink’ and 10 represents ‘very likely to purchase and drink’.
Timepoint [1] 334725 0
Immediately post-randomisation
Secondary outcome [1] 421871 0
Purchase behaviour (image shown): Participants will be asked to imagine they are completing their regular, weekly shop for alcohol, and the price is the same as what they would usually spend, and they are buying from a supermarket, bottle store, uber eats, etc (but not from a bar, pub, or restaurant). Participants will be asked how many bottles or cans of the shown alcoholic drink they would purchase to drink? (Question 20)
Timepoint [1] 421871 0
One-minute post-randomisation
Secondary outcome [2] 433475 0
Unprompted recall 1 (image no longer shown): Participants will be asked if they noticed anything about the image (Yes/No). (Question 21)
Timepoint [2] 433475 0
Two-minutes post-randomisation
Secondary outcome [3] 433476 0
Unprompted recall 2 (image no longer shown): Those who select ‘yes’ to question 21, will be asked to describe what they noticed (using a free-text field).
Timepoint [3] 433476 0
Three-minutes post-randomisation
Secondary outcome [4] 433477 0
Prompted recall 1 (image no longer shown): Participants will be asked if they noticed any warning labels on the image (Yes/No). (Question 22).
Timepoint [4] 433477 0
Four-minutes post-randomisation
Secondary outcome [5] 433478 0
Prompted recall 2 (image no longer shown): Those that answered 'YES" to question 22 will be asked what the message on the warning label was. Answers will be collected using a free-text field.
Timepoint [5] 433478 0
Five-minutes post-randomisation
Secondary outcome [6] 433479 0
Comprehension (image no longer shown): Those that answered 'YES" to the 'Prompted recall 1' question (i.e. Question 22), will be asked what the label wanted them to do. Answers will be collected using a free-text field.
Timepoint [6] 433479 0
Six-minutes post-randomisation
Secondary outcome [7] 433481 0
Judgement 1 (image shown): Participants will be asked if the message(s) on the warning labels were believable (assessed on a 5-point scale, where 1 = Not believable at all and 5 = Very believable). (Question 23)
Timepoint [7] 433481 0
Seven-minutes post-randomisation
Secondary outcome [8] 433482 0
Judgement 2 (image shown): Participants who responded to question 23 with a 1 or 2 will be asked to explain their answer using a free-text field.
Timepoint [8] 433482 0
Eight-minutes post-randomisation
Secondary outcome [9] 433483 0
Behavior (prompted): Participants will be asked if the presence of the warning label(s) influenced the number of drinks they selected to purchase and drink in the previous section (assessed on a 5-point scale, where 1 = No, not at all, and 5 = Yes, very much).
Timepoint [9] 433483 0
Nine-minutes post-randomisation
Secondary outcome [10] 433485 0
Support for warning labels 1: Participants will be asked how strongly they agree or disagree with the following statement: “Alcohol health warning labels should be required on all alcoholic drinks” (assessed on a 7-point scale, where 1 = strongly disagree and 7 = strongly agree). (Question 25)
Timepoint [10] 433485 0
Ten-minutes post-randomisation
Secondary outcome [11] 433487 0
Support for warning labels 2: Participants who responded to question 25, will be asked to explain their answer using a free-text field.
Timepoint [11] 433487 0
Eleven-minutes post-randomisation
Secondary outcome [12] 433490 0
Behavior (prompted): Participants will also be asked if they are likely to discuss the warning labels with family and/or friends (assessed on a 5-point scale where 1 = no, not likely at all and 5 = yes, very likely).
Timepoint [12] 433490 0
Twelve-minutes post-randomisation

Eligibility
Key inclusion criteria
Participants will be:
- Adults (18 years and over);
- Report purchasing and consuming alcohol from an off-license retailer (e.g. supermarket, bottle store, uber eats, etc, but excluding drinking at a bar, pub, or restaurant) in the past week;
- Only people who have drunk beer, wine, spirits or RTDs in the last week will be eligible.
-Able to read English
- Have access to the internet
- Reside in New Zealand
- Have not previously completed a Dynata survey about alcohol
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
- Under 18 years of age
- No access to the internet
- Cannot read English
- Have previously completed a survey about alcohol with Dynata
- Not currently residing in New Zealand
- Did not purchase and drink alcohol (beer, or wine, or spirits, or RTDs) in the past week.

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)
Allocation is concealed. Participants are randomized after the screening process. Randomization sequence generated by the trial statistician and centrally managed through the online platform (i.e. Dynata) and concealed until the point of randomization.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomization using a block randomization.

Stratified by ethnicity (Maori, Pacific, and non-Maori/non-Pacific) and alcohol use (light to moderate; heavy) using block randomization with variable block sizes.

Mild to moderate alcohol use will be indicated by an AUDIT-C score of less than three for women and less than four for men, whilst heavy alcohol use will be indicated by an AUDIT-C score of equal to or greater than three for women and equal to or greater than four for men.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
SAMPLE SIZE: A sample size of 1,000 participants (250 per arm) will confer >90% power at the 5% overall significance level (two-sided) to detect an effect size of 0.33 Standard Deviations (SD) on the primary outcome, between any one of three label groups and the control, with adjustment for multiple comparisons. An approximately equal sample size per ethnic group will provide 90% power at 5% significance to detect a group difference of 0.5 SD in subgroup analysis.

ANALYSIS: See attached Statistical Analysis Plan. (Please see step 11 for attachment).

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/05/2024
Actual
Date of last participant enrolment
Anticipated
30/06/2024
Actual
Date of last data collection
Anticipated
30/06/2024
Actual
Sample size
Target
1000
Accrual to date
Final
Recruitment outside Australia
Country [1] 25499 0
New Zealand
State/province [1] 25499 0

Funding & Sponsors
Funding source category [1] 313828 0
Government body
Name [1] 313828 0
Health Research Council of New Zealand
Country [1] 313828 0
New Zealand
Primary sponsor type
University
Name
University of Auckland
Address
Mailing address:National Institute for Health InnovationSchool of Population Health The University of AucklandPrivate Bag 92019Auckland Mail CentreAuckland 1142 NEW ZEALAND
Country
New Zealand
Secondary sponsor category [1] 315663 0
None
Name [1] 315663 0
Address [1] 315663 0
Country [1] 315663 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 312985 0
University of Auckland Human Participants Ethics Committee (UAHPEC)
Ethics committee address [1] 312985 0
The University of Auckland Private Bag 92019, Auckland, New Zealand
Ethics committee country [1] 312985 0
New Zealand
Date submitted for ethics approval [1] 312985 0
21/02/2022
Approval date [1] 312985 0
13/03/2024
Ethics approval number [1] 312985 0

Summary
Brief summary
The Warning study is a three-stage, mixed methods study, investigating the impact of selected warning labels. The first stage of the study involved focus groups, and was followed by stage two which included an online survey. Three labels were selected to be used in the third stage, the randomized controlled trial. The study was approved by an ethics committee on the 29th March 2022.
The aim of the third stage of the study is to investigate the impact of three selected warning labels versus a 'no label' control condition, on consumers' intent to purchase and drink alcoholic beverages. It is hypothesized, that participants viewing alcoholic beverages with the test warning labels will be less likely to want to purchase and drink the alcoholic beverage. compared with those in the no-label control, irrespective of ethnicity or baseline AUDIT-C score.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 126586 0
Prof Natalie Walker
Address 126586 0
School of Population Health, Faculty of Medical and Health Sciences, University of Auckland Private Bag 92019 Auckland 1142, New Zealand
Country 126586 0
New Zealand
Phone 126586 0
+64 9 923 9884
Fax 126586 0
Email 126586 0
n.walker@auckland.ac.nz
Contact person for public queries
Name 126587 0
Natalie Walker
Address 126587 0
School of Population Health, Faculty of Medical and Health Sciences, University of Auckland Private Bag 92019 Auckland 1142, New Zealand
Country 126587 0
New Zealand
Phone 126587 0
+64 9 923 9884
Fax 126587 0
Email 126587 0
n.walker@auckland.ac.nz
Contact person for scientific queries
Name 126588 0
Natalie Walker
Address 126588 0
School of Population Health, Faculty of Medical and Health Sciences, University of Auckland Private Bag 92019 Auckland 1142, New Zealand
Country 126588 0
New Zealand
Phone 126588 0
+64 9 923 9884
Fax 126588 0
Email 126588 0
n.walker@auckland.ac.nz

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?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
22042Statistical analysis plan    See attached SAP 385882-(Uploaded-19-04-2024-08-14-08)-Study-related document.pdf



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.