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CompletedNCT05842460Updated Aug 14, 2023

Testing "Ultraprocessed" Front-of-package Label Among Brazilian Consumers

An interventional study of Nutrient warning labels and Nutrient and ultraprocessed warning labels in Dietary Exposure, sponsored by University of North Carolina, Chapel Hill. Completed at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-08-14.

Sponsored by University of North Carolina, Chapel Hill · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
1,007
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

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.

02

Conditions studied

  • Dietary Exposure
03

In context

Lead sponsor

University of North Carolina, Chapel Hill is the lead sponsor of 1,340 studies on the registry; 133 are open to participants now.

Of its 155 completed or terminated interventional studies of FDA-regulated products, 136 (88%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • 18 years or older,
  • residing in Brazil,
  • responsible for at least 50% of the household's grocery purchases.

Exclusion criteria

Exclusion criteria:

  • involvement in any pre-testing.
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
1,007 participants (actual)

Study arms

  • 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.

    Behavioral: Nutrient warning labels

  • 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.

    Behavioral: Nutrient and ultraprocessed warning labels

Interventions

  • BehavioralNutrient warning labels

    Inclusion of nutrient warning labels, which are currently mandatory in Brazil, to images of food products.

  • BehavioralNutrient and ultraprocessed warning labels

    Inclusion of nutrient warning labels, which are currently mandatory in Brazil, and an experimental ultraprocessed warning label to images of food products.

06

What researchers measure

Primary outcomes

  1. Purchase intentions

    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.

    Time frame: Online survey within 20 minutes following completion of a ~10 minute shopping task.

Secondary outcomes

  1. Product healthfulness perceptions

    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.

    Time frame: Online survey within 20 minutes following completion of a ~10 minute shopping task.

  2. Product processing status perceptions

    Whether the participant believes products are ultraprocessed will be measured by survey. Responses options are "no," "yes," and "I'm not sure."

    Time frame: Online survey within 20 minutes following completion of a ~10 minute shopping task.

  3. Message effectiveness perceptions

    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.

    Time frame: Online survey within 20 minutes following completion of a ~10 minute shopping task.

07

Study locations

1 site
  • University of North Carolina at Chapel Hill
    Chapel Hill, North Carolina 27516, United States
08

References and documents

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. PubMed 34933866 ↗
  • 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. PubMed 34444941 ↗

Related links

Study documents

  • Statistical analysis plan · May 11, 2023

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: Yes — A deidentified dataset and analytic code will be uploaded to a public repository upon publication of the study.

Supporting information: Analytic code

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 14, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05842460
Lead sponsor
University of North Carolina, Chapel Hill
Collaborators
The Bloomberg Family Foundation, Inc.
Responsible party
Sponsor
First posted
May 6, 2023
Start date
May 24, 2023
Primary completion
Jun 28, 2023
Completion
Jun 28, 2023
Last update
Aug 14, 2023

Study contacts

Lindsey Taillie, PhD
principal investigator · University of North Carolina, Chapel Hill

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2023. You cannot join it, but the record below documents what was studied.

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