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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05842460
Other study ID # 23-0151
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date May 24, 2023
Est. completion date June 28, 2023

Study information

Verified date August 2023
Source University of North Carolina, Chapel Hill
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 1007
Est. completion date June 28, 2023
Est. primary completion date June 28, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
United States University of North Carolina at Chapel Hill Chapel Hill North Carolina

Sponsors (2)

Lead Sponsor Collaborator
University of North Carolina, Chapel Hill The Bloomberg Family Foundation, Inc.

Country where clinical trial is conducted

United States, 

References & Publications (2)

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. — View Citation

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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. Online survey within 20 minutes following completion of a ~10 minute shopping task.
Secondary 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. Online survey within 20 minutes following completion of a ~10 minute shopping task.
Secondary 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." Online survey within 20 minutes following completion of a ~10 minute shopping task.
Secondary 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. Online survey within 20 minutes following completion of a ~10 minute shopping task.
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