- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05842460
Testing "Ultraprocessed" Front-of-package Label Among Brazilian Consumers
Testing the Impact of an "Ultraprocessed" Front-of-package Warning Label Among Brazilian Consumers
The goal of this experiment is to test the effects an "ultraprocessed" warning label on foods and beverages among Brazilian consumers. The main questions it aims to answer are:
- Do "ultraprocessed" warnings affect Brazilian consumers' intention to purchase products?
- Do "ultraprocessed" warnings affect Brazilian consumers' product perceptions?
Participants will see images of four products carrying either nutrient warning labels (which are currently mandatory in Brazil) or nutrient warning labels alongside an experimental warning label informing that the product is ultraprocessed. Participants will then answer survey questions about each product. Researchers will compare responses between both arms to determine if the "ultraprocessed" warning significantly changes the effect of nutrient warnings.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
North Carolina
-
Chapel Hill, North Carolina, United States, 27516
- University of North Carolina at Chapel Hill
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion criteria:
- 18 years or older,
- residing in Brazil,
- responsible for at least 50% of the household's grocery purchases.
Exclusion criteria:
- involvement in any pre-testing.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Nutrient warnings
Individuals in this trial arm will see images of products carrying nutrient warnings that are currently included in Brazil's front-of-package labeling scheme.
|
Inclusion of nutrient warning labels, which are currently mandatory in Brazil, to images of food products.
|
|
Experimental: Nutrient and ultraprocessed warnings
Individuals in this trial arm will see images of products carrying nutrient warnings that are currently included in Brazil's front-of-package labeling scheme and an experimental warning stating that the product is ultraprocessed.
|
Inclusion of nutrient warning labels, which are currently mandatory in Brazil, and an experimental ultraprocessed warning label to images of food products.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Purchase intentions
Time Frame: Online survey within 20 minutes following completion of a ~10 minute shopping task.
|
How likely the participant would be to buy products will be measured by survey.
Response options are on a 1 to 5 scale, with higher scores representing a higher likelihood of buying products.
|
Online survey within 20 minutes following completion of a ~10 minute shopping task.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Product healthfulness perceptions
Time Frame: Online survey within 20 minutes following completion of a ~10 minute shopping task.
|
How healthy products seem to the participant will be measured by survey.
Response options are on a 1 to 5 scale, with higher scores representing a higher perceived product healthfulness.
|
Online survey within 20 minutes following completion of a ~10 minute shopping task.
|
|
Product processing status perceptions
Time Frame: Online survey within 20 minutes following completion of a ~10 minute shopping task.
|
Whether the participant believes products are ultraprocessed will be measured by survey.
Responses options are "no," "yes," and "I'm not sure."
|
Online survey within 20 minutes following completion of a ~10 minute shopping task.
|
|
Message effectiveness perceptions
Time Frame: Online survey within 20 minutes following completion of a ~10 minute shopping task.
|
Perceived message effectiveness of the study labels will be measured by survey through a three-item scale.
Items inquire about how much the labels discourage the participant from wanting to consume the products, how much the labels make the participant concerned about the health effects of consuming the products, and how much the labels make consuming the products seem unpleasant.
Response options are on a 1 to 5 scale, with higher scores representing a higher perceived message effectiveness of the study labels.
|
Online survey within 20 minutes following completion of a ~10 minute shopping task.
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Lindsey Taillie, PhD, University of North Carolina, Chapel Hill
Publications and helpful links
General Publications
- Cotter T, Kotov A, Wang S, Murukutla N. 'Warning: ultra-processed' - A call for warnings on foods that aren't really foods. BMJ Glob Health. 2021 Dec;6(12):e007240. doi: 10.1136/bmjgh-2021-007240. No abstract available.
- Romero Ferreiro C, Lora Pablos D, Gomez de la Camara A. Two Dimensions of Nutritional Value: Nutri-Score and NOVA. Nutrients. 2021 Aug 13;13(8):2783. doi: 10.3390/nu13082783.
Helpful Links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 23-0151
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- ANALYTIC_CODE
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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