Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12616000626460
Ethics application status
Approved
Date submitted
11/05/2016
Date registered
16/05/2016
Date last updated
16/05/2016
Type of registration
Retrospectively registered

Titles & IDs
Public title
Consumer Evaluations of Pre-Packaged Foods that Systematically Vary by Front-of-Pack Label, Health Claim, Price and Healthiness
Scientific title
Consumer Evaluations of Pre-Packaged Foods that Systematically Vary by Front-of-Pack Label, Health Claim, Price and Healthiness
Secondary ID [1] 289180 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Obesity 298728 0
Coronary heart disease 298729 0
Hypertension 298730 0
Type 2 diabetes 298731 0
Condition category
Condition code
Public Health 298778 298778 0 0
Health promotion/education

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention will involve presenting participants with hypothetical images of food packs that have been manipulated on the following attributes: healthiness (3 levels), front-of-pack label (4 levels), health claims (4 levels), price (3 levels) and food type (4 levels). All attributes will simultaneously appear in each hypothetical food pack image but the level of each attribute will vary across images. The attributes will be fully crossed with each other resulting in a pool of 576 total possible images (i.e. 3 x 4 x 4 x 3 x 4 = 576). Each participant will be exposed to 8 images that will be drawn pseudo randomly from the larger pool with the constraints that each participant be exposed to 2 of each type of front-of-pack label and 2 of each food type. Each attribute is described in detail below.

Front-of-pack label:
Contains a control condition and 3 levels: no label, the Daily Intake Guide, Multiple Traffic Lights, Health Star Rating. Each participant will be exposed to all 4 levels of this attribute (i.e. they will be presented with 2 packs of each label type) and will act as their own control.

Food type:
Contains 4 levels: corn flakes, cookies, pizza, yogurt. Each participant will be exposed to all 4 levels of this attribute (i.e. they will be presented with 2 packs of each food type).

Health claims:
Contains a control condition and 3 levels: no claim, nutrient content claim, general level claim, higher level claim. Across all participant exposures to images, a quarter of the exposures will come from each of the 4 levels of the health claims attribute.

Price:
Contains 3 levels: cheap, moderate price, expensive. Across all participant exposures to images, a third of the exposures will come from each of the 3 levels of the price attribute.

Healthiness:
Contains 3 levels: unhealthy, moderately healthy, healthy. Across all participant exposures to images, a third of the exposures will come from each of the 3 levels of the healthiness attribute.


Images of the hypothetical food packs will be viewed online by individual participants in a location of their choice. Participants will be allowed to view each image for as long as they require and thus the duration of the intervention will depend on the individual participant. It is estimated that participants will spend approximately 30 - 60 seconds viewing and answering questions about each image.
Intervention code [1] 294709 0
Prevention
Comparator / control treatment
The study will have a repeated measures design with between and within subjects comparisons. Multiple interventions will be tested simultaneously within and across participants. These interventions will involve varying the following attributes of each food pack image: front-of-pack label, health claim, healthiness, price and food type. The attributes of front-of-pack label and health claim contain a control condition while the remaining attributes (food type, price, healthiness) do not feature a control condition but comparisons will be conducted to observe how outcomes vary as a result of each level.
Control group
Active

Outcomes
Primary outcome [1] 298247 0
Perceived healthiness of the product, assessed using a questionnaire designed specifically for the study.
Timepoint [1] 298247 0
After exposure to each hypothetical product pack image.
Primary outcome [2] 298248 0
Intention to purchase the product, assessed using a questionnaire designed specifically for the study.
Timepoint [2] 298248 0
After exposure to each hypothetical product pack image.
Primary outcome [3] 298249 0
Amount of the product considered desirable/appropriate to eat, assessed using images from an image bank (Blechert, J., Meule, A., Busch, N. A., & Ohla, K. (2014). Food-pics: an image database for experimental research on eating and appetite. Eating Behavior, 5, 617. http://doi.org/10.3389/fpsyg.2014.00617).
Timepoint [3] 298249 0
After exposure to each hypothetical product pack image.
Secondary outcome [1] 323649 0
Overall perception of the product (e.g., perceived tastiness, quality), assessed using a questionnaire designed specifically for the study.
Timepoint [1] 323649 0
After exposure to each hypothetical product pack image.

Eligibility
Key inclusion criteria
Participants must be aged over 10 and currently reside in Australia.
Minimum age
10 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Demographic quotas based on age, sex 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
Non-randomised 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
Other design features
The intervention consists of varying hypothetical food packs along 5 attributes in order to observe the main effect and interaction effects of each attribute. The front-of-pack label and food type attributes are within subjects and each participant will act as their own control. The remaining attributes (price, healthiness and health claim) are between subjects variables.
Phase
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
19/02/2016
Date of last participant enrolment
Anticipated
Actual
12/04/2016
Date of last data collection
Anticipated
Actual
Sample size
Target
2004
Accrual to date
Final
2059
Recruitment in Australia
Recruitment state(s)
ACT,NSW,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 293563 0
Government body
Name [1] 293563 0
Australian Research Council
Country [1] 293563 0
Australia
Primary sponsor type
University
Name
Curtin University
Address
Curtin University, Kent St,
Bentley,
WA, 6102
Country
Australia
Secondary sponsor category [1] 292381 0
None
Name [1] 292381 0
Address [1] 292381 0
Country [1] 292381 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 295007 0
Curtin University Ethics Committee
Ethics committee address [1] 295007 0
Ethics committee country [1] 295007 0
Australia
Date submitted for ethics approval [1] 295007 0
15/12/2014
Approval date [1] 295007 0
15/01/2015
Ethics approval number [1] 295007 0
RDHS-11-15

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

Contacts
Principal investigator
Name 65758 0
Dr Zenobia Talati
Address 65758 0
School of Psychology and Speech Pathology,
Curtin University, Kent St,
Bentley,
WA, 6102
Country 65758 0
Australia
Phone 65758 0
+61 8 92664396
Fax 65758 0
Email 65758 0
[email protected]
Contact person for public queries
Name 65759 0
Zenobia Talati
Address 65759 0
School of Psychology and Speech Pathology,
Curtin University, Kent St,
Bentley,
WA, 6102
Country 65759 0
Australia
Phone 65759 0
+61 8 92664396
Fax 65759 0
Email 65759 0
[email protected]
Contact person for scientific queries
Name 65760 0
Zenobia Talati
Address 65760 0
School of Psychology and Speech Pathology,
Curtin University, Kent St,
Bentley,
WA, 6102
Country 65760 0
Australia
Phone 65760 0
+61 8 92664396
Fax 65760 0
Email 65760 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
No additional documents have been identified.