Impacts of Warning Labels on Ultra-Processed Foods

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Health Behavior; Diet, Healthy
• Intervention / Treatment: Behavioral: Health Warning Label; Behavioral: Identity Warning Label; Other: Barcode Label

Detailed 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.

• Study Type: Interventional
• Enrollment (Estimated): 4000
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Lindsey Smith Taillie, PhD; Phone Number: (919) 445-8313; Email: taillie@unc.edu
• Study Contact Backup: Name: Violet Noe, MPH; Email: violetn@email.unc.edu

Study Locations

• United States
  • North Carolina
    • Chapel Hill, North Carolina, United States, 27516
      • UNC Carolina Population Center
      • Contact: Violet Noe; Email: violetn@email.unc.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Health Warning Label; Participants will view four products (a fruit-flavored drink, pretzels, a yogurt, and a breakfast cereal) each with a health warning label displayed on the front of package.	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."
Experimental: Identity Warning Label; Participants will view four products (a fruit-flavored drink, pretzels, a yogurt, and a breakfast cereal) each with an identity warning label displayed on the front of package.	Behavioral: Identity Warning Label; Message displayed on warning label is: "WARNING: Ultra-processed food".
Other: Barcode Label; Participants will view four products (a fruit-flavored drink, pretzels, a yogurt, and a breakfast cereal) each with a barcode control label displayed on the front of package.	Other: Barcode Label; Barcode is displayed.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.
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.
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.

Collaborators and Investigators

• Sponsor: University of North Carolina, Chapel Hill
• Collaborators: Robert Wood Johnson Foundation
• Investigators: Principal Investigator: Lindsey Smith Taillie, PhD, University of North Carolina, Chapel Hill

Study record dates

Study Major Dates

• Study Start (Estimated): May 31, 2024
• Primary Completion (Estimated): June 20, 2024
• Study Completion (Estimated): June 20, 2024

Study Registration Dates

• First Submitted: February 28, 2024
• First Submitted That Met QC Criteria: February 28, 2024
• First Posted (Actual): March 6, 2024

Study Record Updates

• Last Update Posted (Actual): April 18, 2024
• Last Update Submitted That Met QC Criteria: April 16, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: front-of-package labels; ultra-processed food; food and beverage purchases
• Other Study ID Numbers: 24-0300d

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: A deidentified dataset and the corresponding survey codebook will be shared beginning 9 months and continuing for 36 months after publication provided the investigator who proposes to use the data has approval from an Institutional Review Board (IRB), Independent Ethics Committee (IEC), or Research Ethics Board (REB), as applicable, and executes a data use/sharing agreement with UNC. The study protocol, statistical analysis plan, and informed consent form will be published alongside as supplementary material.
• IPD Sharing Time Frame: beginning 9 and continuing for 36 months following publication of study results.
• IPD Sharing Access Criteria: Investigator has approved IRB, IEC, or REB and an executed data use/sharing agreement with UNC.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No