Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12618001221246
Ethics application status
Approved
Date submitted
17/07/2018
Date registered
20/07/2018
Date last updated
6/08/2018
Type of registration
Retrospectively registered

Titles & IDs
Public title
Attitudes, objective understanding, and food choices associated with front-of-pack nutrition labels across 12 countries
Scientific title
Attitudes, objective understanding, and food choices associated with front-of-pack nutrition labels across 12 countries
Secondary ID [1] 295570 0
None
Universal Trial Number (UTN)
Trial acronym
FOP-ICE (Front-Of-Pack International Comparative Experiment)
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Obesity 308840 0
Coronary heart disease 308841 0
Hypertension 308842 0
Type 2 diabetes 308843 0
Condition category
Condition code
Public Health 307775 307775 0 0
Health promotion/education

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants will complete an online survey (hosted by an ISO accredited web panel provider) taking approximately 15 – 20 minutes. They will first be asked a series of socio-demographic questions before making decisions about fictional food products. Specifically, they will see 3 versions (1 healthy, 1 moderately healthy and 1 unhealthy) of 3 foods (breakfast cereals, cakes and pizzas) and will engage in a choice task followed by a ranking task for each set of 3 food products. In the choice task, respondents will choose from each set which product they would prefer to buy. An “I wouldn’t buy any of these products” option will also be available. Following the choice task, respondents will be asked to rank the 3 products from most to least healthy. An “I don’t know” option will also be included.
Respondents will then be randomly assigned to one of the five front-of-pack label (FoPL) conditions; Health Star Rating system (HSR), Multiple Traffic Light (MTL) system, Nutri-Score, Reference Intakes (RIs) label, and Warning symbols. The same three sets of products shown in the control condition will be presented but this time with the randomly allocated FoPL present on the mock packages. Respondents will complete the same choice and ranking tasks from the control condition. Order effects will be controlled for by randomizing the presentation order of the products.
Finally, respondents will be asked their perceptions of the FoPL they saw. A picture of the label will be shown and they will be asked whether they remember seeing the label on the food products shown in the survey. This will be followed by a series of questions asking about attitudes to the FOP label assessing liking (e.g. “I like this label”), usefulness (e.g. “This FoP label is useful”), awareness (e.g. “This FoP label stands out”), and perceived cognitive workload (e.g. “This label is easy to understand”). Each question will be rated on a 9-point Likert scale ranging from “Strongly disagree” to “Strongly agree”.
Intervention code [1] 301869 0
Prevention
Comparator / control treatment
Each respondent will serve as their own control in this within-between subjects design. The control treatment will be administered first and will involve presenting respondents with 3 sets of 3 products with no front-of-pack label present.
Control group
Active

Outcomes
Primary outcome [1] 306763 0
Healthiness of food choice. Respondents will select one food product from 3 options within each choice set, scored from 1 (lower nutritional quality product) to 3 (higher nutritional quality product). Respondents selecting the “I wouldn’t buy any of these products” option will not be included in analyses.
Timepoint [1] 306763 0
Following presentation of each food choice set
Primary outcome [2] 306764 0
Accuracy in ranking the healthiness of 3 foods within each choice set. Respondents will use the drop down menu under each product to rank it as either '1 - Highest nutritional quality', '2 - Medium nutritional quality' or '3 - Lowest nutritional quality'.
Timepoint [2] 306764 0
Following presentation of each food choice set
Secondary outcome [1] 349534 0
Perceptions of the front-of-pack label shown in the randomisation condition. Measured through a series of items rated on a 9 point Likert scale.
Timepoint [1] 349534 0
At the end of the survey, after choice and ranking tasks are completed

Eligibility
Key inclusion criteria
Respondents must be aged 18 and over and must reside in one of the following countries: Argentina, Australia, Bulgaria, Canada, Denmark, France, Germany, Mexico, Singapore, Spain, the United Kingdom, and the United States of America.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Demographic quotas based on age, sex, income and location will be used. Participants will be excluded if the quota bracket which they belong in has been filled.

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)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
13/03/2018
Date of last participant enrolment
Anticipated
30/07/2018
Actual
25/07/2018
Date of last data collection
Anticipated
30/07/2018
Actual
25/07/2018
Sample size
Target
12000
Accrual to date
Final
12015
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC
Recruitment outside Australia
Country [1] 10647 0
Argentina
State/province [1] 10647 0
Country [2] 10648 0
Bulgaria
State/province [2] 10648 0
Country [3] 10649 0
Canada
State/province [3] 10649 0
Country [4] 10650 0
Denmark
State/province [4] 10650 0
Country [5] 10651 0
France
State/province [5] 10651 0
Country [6] 10652 0
Germany
State/province [6] 10652 0
Country [7] 10653 0
Mexico
State/province [7] 10653 0
Country [8] 10654 0
Singapore
State/province [8] 10654 0
Country [9] 10655 0
Spain
State/province [9] 10655 0
Country [10] 10656 0
United Kingdom
State/province [10] 10656 0
Country [11] 10657 0
United States of America
State/province [11] 10657 0

Funding & Sponsors
Funding source category [1] 300146 0
Government body
Name [1] 300146 0
Santé Publique France
Country [1] 300146 0
France
Funding source category [2] 300160 0
University
Name [2] 300160 0
Curtin University
Country [2] 300160 0
Australia
Primary sponsor type
University
Name
Curtin Univerisity
Address
Curtin University, Kent St,
Bentley,
WA, 6102
Country
Australia
Secondary sponsor category [1] 299548 0
University
Name [1] 299548 0
Université Paris 13
Address [1] 299548 0
UFR SMBH 74 rue Marcel Cachin,
93017 Bobigny, France
Country [1] 299548 0
France

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 300978 0
Curtin University Human Research Ethics Committee
Ethics committee address [1] 300978 0
Ethics committee country [1] 300978 0
Australia
Date submitted for ethics approval [1] 300978 0
Approval date [1] 300978 0
30/10/2017
Ethics approval number [1] 300978 0
Ethics committee name [2] 300992 0
CEEI-IRB (Comité d'Evaluation Ethique de l'INSERM)
Ethics committee address [2] 300992 0
Ethics committee country [2] 300992 0
France
Date submitted for ethics approval [2] 300992 0
23/08/2017
Approval date [2] 300992 0
19/09/2017
Ethics approval number [2] 300992 0
17-4014

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

Contacts
Principal investigator
Name 85494 0
Prof Simone Pettigrew
Address 85494 0
School of Psychology,
Curtin University, Kent St,
Bentley,
WA, 6102
Country 85494 0
Australia
Phone 85494 0
+61 8 9266 7990
Fax 85494 0
Email 85494 0
[email protected]
Contact person for public queries
Name 85495 0
Simone Pettigrew
Address 85495 0
School of Psychology,
Curtin University, Kent St,
Bentley,
WA, 6102
Country 85495 0
Australia
Phone 85495 0
+618 9266 7990
Fax 85495 0
Email 85495 0
[email protected]
Contact person for scientific queries
Name 85496 0
Simone Pettigrew
Address 85496 0
School of Psychology,
Curtin University, Kent St,
Bentley,
WA, 6102
Country 85496 0
Australia
Phone 85496 0
+618 9266 7990
Fax 85496 0
Email 85496 0
[email protected]

No information has been provided regarding IPD availability


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
Dimensions AIConsumers’ food choices, understanding and perceptions in response to different front-of-pack nutrition labelling systems in Belgium: results from an online experimental study2020https://doi.org/10.1186/s13690-020-00404-3
Dimensions AIFront-of-pack nutrition labels: an equitable public health intervention2022https://doi.org/10.1038/s41430-022-01205-3
N.B. These documents automatically identified may not have been verified by the study sponsor.