Impacts of Warning Labels on Ultra-Processed Foods

Health Behavior Clinical Trial

Official title:

Impacts of Warning Labels on Ultra-Processed Foods

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06296355
• Other study ID #: 24-0300d
• Status: Not yet recruiting
• Phase: N/A
• Start date: July 1, 2024
• Est. completion date: July 21, 2024

Study information

• Verified date: May 2024
• Source: University of North Carolina, Chapel Hill
• Contact: Lindsey Smith Taillie, PhD
• Phone: (919) 445-8313
• Email: taillie[@]unc.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Purpose: The overall purpose of this study is to identify the impacts of an ultra-processed (UPF) health warning label and UPF identify warning label compared to a control label (i.e., a barcode).

Participants: ~4,000 US Latino adults of parental age (18-55 years), approximately 50% of whom will have limited English proficiency, recruited from a Latino-focused panel company.

Procedures: Participants will be randomly assigned to view food products with one of three label types: health warning labels, identity labels, or barcode control labels. Participants will be asked a series of questions about the products and the label they were assigned.

Description:

On the study platform (Qualtrics), participants will be randomly assigned to 1 of 3 arms with equal probability: a UPF health warning label, a UPF identity label, or a barcode control label. Participants will view four products (a fruit-flavored drink, pretzels, a yogurt, and a breakfast cereal) displayed in random order, each with a label displayed on the front of package according to the participants' study arm. Participants will complete a 13-item online survey to assess each product as to a) whether the product is ultra-processed; b) perceptions of healthfulness; c) intentions to purchase the product.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 4000
• Est. completion date: July 21, 2024
• Est. primary completion date: July 21, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

Inclusion Criteria:

• Identifying as Latino or Hispanic

• Ages 18-55 years old

• Currently resides in the United States

Exclusion Criteria:

• Not identifying as Latino or Hispanic

• Less than 18 or greater than 55 years old

• Not residing in the United States

Related Conditions & MeSH terms

• Diet, Healthy
• Health Behavior

Intervention

Behavioral:
• Health Warning Label
Message displayed on warning label is: "WARNING: Consuming ultra-processed food and drinks can cause weight gain, which increases the risk of obesity and type 2 diabetes."
• Identity Warning Label
Message displayed on warning label is: "WARNING: Ultra-processed food".

Other:
• Barcode Label
Barcode is displayed.

Locations

Country	Name	City	State
United States	UNC Carolina Population Center	Chapel Hill	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
University of North Carolina, Chapel Hill	Robert Wood Johnson Foundation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Identification of a product as ultra-processed	Correct identification of a product as ultra-processed. Measured with the question, "Do you think this product is ultra-processed?" Response options are Yes, No, and I'm not sure.	Immediately after exposure to intervention, assessed during 1-time online study visit.
Secondary	Perceived product healthfulness of ultra-processed products	Measured with the question, "How healthy or unhealthy would it be to eat this product every day?" Likert responses are on a 1 to 5 scale, from "Very unhealthy" (coded as 1) to "Very healthy" (coded as 5), with higher scores representing a higher perceived healthfulness.	Immediately after exposure to intervention, assessed during 1-time online study visit.
Secondary	Intentions to purchase ultra-processed products	Measured with the question, "How likely would you be to purchase this product in the next week, if it were available?" Likert responses are on a 1 to 5 scale, from "Not at all likely" (coded as 1) to "Extremely likely" (coded as 5), with higher scores representing a higher intention to purchase ultra-processed products.	Immediately after exposure to intervention, assessed during 1-time online study visit.
Secondary	Perceived message effectiveness	Measured with the question, "How much does this message discourage you from wanting to eat an ultra-processed product?" Likert responses are on a 1 to 5 scale, from "Not at all" (coded as 1) to "Very much" (coded as 5), with higher scores representing a higher perceived message effectiveness.	Immediately after exposure to intervention, assessed during 1-time online study visit.