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

Diet, Healthy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06293963
• Other study ID #: 24-0300a
• Status: Not yet recruiting
• Phase: N/A
• Start date: May 27, 2024
• Est. completion date: July 5, 2024

Study information

• Verified date: April 2024
• Source: University of North Carolina, Chapel Hill
• Contact: Marissa G Hall, PhD
• Phone: (919) 445-1310
• Email: mghall[@]unc.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 4000
• Est. completion date: July 5, 2024
• Est. primary completion date: July 5, 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

• 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

Related Conditions & MeSH terms

• Diet, Healthy

Intervention

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.
• Interpretive text-only label
Interpretive text-only labels that state when a product contains high amounts of added sugar, sodium, or saturated fat.
• 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.
• 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.

Locations

Country	Name	City	State
United States	The University of North Carolina at Chapel Hill's Gillings School of Global Public Health	Chapel Hill	North Carolina

Sponsors (3)

Lead Sponsor	Collaborator
University of North Carolina, Chapel Hill	Duke University, Stanford University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Secondary	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.
Secondary	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	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.