Front-of-package Label Effects in Latine and Limited English Proficiency Populations

Centering Equity in FDA Regulation: Front-of-package Food Label Effects in Latine and Limited English Proficiency Populations

The goal of this experiment is to examine the effects of 4 types of front-of-package food labels among a sample of Latino adults. The main questions this experiment aims to answer are:

What front-of-package label design is most effective in helping Latino and low English proficiency consumers identify healthier and less healthy food products?

What front-of-package label design is most effective in helping Latino and low English proficiency consumers choose healthier food products?

Additionally, this experiment also aims to answer the following question:

Do the benefits of front-of-package label designs differ by English proficiency and parental status?

Participants will be randomly assigned to 1 of 4 types of front-of-package label designs and view their assigned label design on 3 sets of products. Each set will display 3 similar products, each high in either 1, 2, or 3 nutrients of concern. For each set, participants will select the product that they believe to be the healthiest, least healthy, and the product that they would most want to consume. Researchers will compare results across label designs.

Study Overview

• Status: Completed
• Conditions: Diet, Healthy
• Intervention / Treatment: Behavioral: Guideline Daily Amounts label; Behavioral: Interpretive text-only label; Behavioral: Interpretive magnifying glass icon label; Behavioral: Separated interpretive magnifying glass icon label

Detailed Description

This study aims to determine which front-of-package label design is most effective at helping Latino consumers identify and choose healthier products, as well as explore whether the benefits of different front-of-package label designs differ by English proficiency. A Latino-focused panel company will recruit 4,000 US Latino adults of parental age (18-55 years), approximately 50% of whom will have limited English proficiency.

In a between-subjects experiment, researchers will randomize participants to 1 of 4 types of front-of-package label designs: a numerical label, an interpretive text-only label, an interpretive label with a magnifying glass icon, or separated interpretive labels with a magnifying glass icon. Participants will view their assigned label design on 3 similar products (each product high in either 1, 2, or 3 nutrients of concern) and complete selection tasks. These tasks will be repeated 3 times, each time with a different type of product (i.e., frozen meals, frozen pizzas, and frozen desserts), with the products displayed in random order.

• Study Type: Interventional
• Enrollment (Actual): 3306
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Chapel Hill, North Carolina, United States, 27599
      • The University of North Carolina at Chapel Hill's Gillings School of Global Public Health

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
• Residing in US

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

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Numerical label	Behavioral: Guideline Daily Amounts label; Labels that list the amount and percent of daily value of added sugar, sodium, or saturated fat, modeled after Guideline Daily Amounts labels.
Experimental: Interpretive text-only label	Behavioral: Interpretive text-only label; Interpretive text-only labels that state when a product contains high amounts of added sugar, sodium, or saturated fat.
Experimental: Interpretive magnifying glass icon label	Behavioral: Interpretive magnifying glass icon label; Interpretive labels that state when a product contains high amounts of added sugar, sodium, or saturated fat, containing a magnifying glass icon.
Experimental: Separated interpretive magnifying glass icon label	Behavioral: Separated interpretive magnifying glass icon label; Interpretive labels that state when a product contains high amounts of added sugar, sodium, or saturated fat, containing a magnifying glass icon. Each nutrient will be on a separate label.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Correct identification of healthiest product	Correct identification of healthiest product will be measured by survey. Responses will be coded in a dichotomous 0-1 range, where 1 indicates that the participant correctly identified the healthiest product and 0 indicates that the participant incorrectly identified one of the other two less healthy products as the healthiest product.	During exposure to intervention (i.e., study stimuli), assessed during one-time online 10-minute survey.
Correct identification of least healthy product	Correct identification of least healthy product will be measured by survey. Responses will be coded in a dichotomous 0-1 range, where 1 indicates that the participant correctly identified the least healthy product and 0 indicates that the participant incorrectly identified one of the other two healthier products as the least healthy product.	During exposure to intervention (i.e., study stimuli), assessed during one-time online 10-minute survey.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Selection of healthiest product for purchase	Selection of healthiest product for purchase will be measured by survey. Responses will be coded in a dichotomous 0-1 range, where 1 indicates that the participant chose the healthiest product and 0 indicates that the participants selected one of the other two less healthy products.	During exposure to intervention (i.e., study stimuli), assessed during one-time online 10-minute survey.
Correct identification of products high in nutrients	Correct identification of products high in nutrients (i.e., sugar, saturated fat, or sodium) will be measured by survey. Responses will be coded in a dichotomous 0-1 range, where 1 indicates that the participant correctly identified products that are high in a given nutrient and 0 indicates that the participant incorrectly identified products that are not high in a given nutrient as being high in such nutrient.	During exposure to intervention (i.e., study stimuli), assessed during one-time online 10-minute survey.

Collaborators and Investigators

• Sponsor: University of North Carolina, Chapel Hill
• Collaborators: Duke University; Stanford University
• Investigators: Principal Investigator: Marissa G Hall, PhD, University of North Carolina, Chapel Hill

Study record dates

Study Major Dates

• Study Start (Actual): August 9, 2024
• Primary Completion (Actual): September 11, 2024
• Study Completion (Actual): September 11, 2024

Study Registration Dates

• First Submitted: February 27, 2024
• First Submitted That Met QC Criteria: February 27, 2024
• First Posted (Actual): March 5, 2024

Study Record Updates

• Last Update Posted (Actual): April 24, 2025
• Last Update Submitted That Met QC Criteria: April 21, 2025
• Last Verified: October 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Autonomic Agents; Peripheral Nervous System Agents; Neurotransmitter Agents; Membrane Transport Modulators; Adrenergic Agents; Central Nervous System Stimulants; Dopamine Uptake Inhibitors; Neurotransmitter Uptake Inhibitors; Dopamine Agents; Adrenergic Uptake Inhibitors; Sympathomimetics; Methamphetamine
• Other Study ID Numbers: 24-0300a

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The Study Protocol and Statistical Analysis Plan will be shared prior to data collection. After data collection and analysis, a de-identified version of individual participant data and the analytic code will be shared through the Open Science Framework (OSF).
• IPD Sharing Time Frame: The Study Protocol and SAP will be available by mid-March 2024 (prior to data collection). IPD and analytic code will become available after data collection and analysis.
• IPD Sharing Access Criteria: Open access.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ANALYTIC_CODE

Drug and device information, study documents

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