Assessing the Impact of Front-of-package Nutrient Labels

June 19, 2025 updated by: Jennifer Falbe, University of California, Davis

Assessing the Impact of Front-of-package Nutrient Labels on Consumer Understanding and Behavior

This study aims to compare different front-of-package label designs, using two schemes: (1) High In and (2) Nutrition Info with each scheme having (1) a version with colors (i.e., green, yellow, and/or red) indicating level of nutrient content and (2) a black-and-white version. Additionally the Nutrition Info scheme will have a version that includes the percent Daily Value in black and white. Labels will be compared against a no-label control and one another.

Study Overview

Detailed Description

This study aims to compare different front-of-package label designs, using two schemes: (1) High In and (2) Nutrition Info. The labels will have variations, such as color, and will be compared to a no-label control and one another. There will be a total of 6 experimental conditions: 1) High In label with color; 2) High In label in black and white; 3) Nutrition Info label with color; 4) Nutrition Info in black and white; 5) Nutrition Info label in black and white with percent Daily Value listed; and 6) a no-label control.

Participants will view a series of food-and-beverage products labeled (or not) according to condition. The three primary outcomes are: (1) correct assessment of high nutrient contents in food-and-beverage products, (2) perceived healthfulness of packaged foods and beverages, and (3) selection of at least one item high in at least one nutrient of concern (saturated fat, sodium, added sugar) in a shopping task. Perceived message effectiveness will be examined as a secondary outcome.

All statistical analyses will use two-tailed tests with a significance level of <0.05. Per CONSORT Guidelines, all models comparing labels will be bivariate, regressing outcomes on indicators for labeling condition. For continuous outcomes, linear regression models will be used, and for dichotomous outcomes, risk ratios (or probability ratios) will be estimated using Poisson regression with a robust error variance.

Effect modification of the labels on primary outcomes will be explored for type 2 diabetes status and sociodemographic variables important for health equity using interaction terms and stratified models.

Additionally, differences in the primary outcomes between each of the 6 unique conditions will be explored.

Study Type

Interventional

Enrollment (Actual)

10601

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • California
      • Davis, California, United States, 96516
        • University of California, Davis

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Equal or greater than 18 years of age
  • English-speaking
  • U.S. residents
  • Have eaten restaurant food at least once in the last month
  • Participants will reflect the U.S. Census Bureau's 2021 American Community Survey 5-year estimates for gender, race/ethnicity, educational attainment, and age

Exclusion Criteria:

  • Failing the attention check question
  • Completing the survey in less than 33% of the median completion time

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Factorial Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: No-label Control
Participants will see packaged food-and-beverage items with no front-of-package labels (other than any posted by the manufacturer).
Experimental: High-In with color

Participants will see packaged food-and-beverage items displaying front-of-package labels that say, "High In [nutrient]" (nutrients: saturated fat, sodium, or added sugar) if the item contains 20% or more of the daily recommended limit per serving for each nutrient. The nutrients will be highlighted in red.

If the item is not high in 1 or 2 of the nutrients, the nutrient(s) will not be on the label. If the item is not high in any of the 3 nutrients, the product will not display this label.

Participants will see packaged food-and-beverage items displayed with labels as specified by their assigned group
Experimental: High-In black and white

Participants will see packaged food-and-beverage items displaying front-of-package labels that say, "High In [nutrient]" (nutrients: saturated fat, sodium, or added sugar) if the item contains 20% or more of the daily recommended limit per serving for each nutrient. The label will have a white background and black text.

If the item is not high in 1 or 2 of the nutrients, the nutrient(s) will not be on the label. If the item is not high in any of the 3 nutrients, the product will not display this label.

Participants will see packaged food-and-beverage items displayed with labels as specified by their assigned group
Experimental: Nutrition Info with color
Participants will see packaged food-and-beverage items displaying front-of-package labels that list "high", "medium", or "low" for saturated fat, sodium, and added sugars. "High" is defined as 20% or more of the daily recommended limit per serving, "medium" as 6-19%, and "low" as 5% or less. The word "high" will be highlighted red; the word "medium" will be highlighted yellow; and the word "low" will be highlighted green.
Participants will see packaged food-and-beverage items displayed with labels as specified by their assigned group
Experimental: Nutrition Info black and white
Participants will see packaged food-and-beverage items displaying front-of-package labels that list "high", "medium", or "low" for saturated fat, sodium, and added sugars. "High" is defined as 20% or more of the daily recommended limit per serving, "medium" as 6-19%, and "low" as 5% or less. The label will have a white background and black text.
Participants will see packaged food-and-beverage items displayed with labels as specified by their assigned group
Experimental: Nutrition Info without color, with percent Daily Value
Participants will see packaged food-and-beverage items displaying front-of-package labels that list "high", "medium", or "low" for saturated fat, sodium, and added sugars. "High" is defined as 20% or more of the daily recommended limit per serving, "medium" as 6-19%, and "low" as 5% or less. The label will also list the exact percent of the daily recommended limit (i.e., daily value) for each nutrient per serving. The label will have a white background and black text.
Participants will see packaged food-and-beverage items displayed with labels as specified by their assigned group

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Perceived healthfulness
Time Frame: Within approximately 5 minutes of intervention exposure
Participants will provide a healthfulness score (response scale from 1-7) for up to 6 different products. The average score across products will be used as a continuous outcome in linear regression models. In sensitivity analyses, scores will be examined by product and product grouping.
Within approximately 5 minutes of intervention exposure
Selection of a product high in a nutrient of concern
Time Frame: Within approximately 5 minutes of intervention exposure
Participants will select a food and beverage they would purchase for themselves from hypothetical grocery store shelves displaying foods and beverages. The dichotomous outcome is selection of an item that is high in at least one nutrient of concern (compared to not selecting an item high in at least one nutrient of concern), examined overall and separately for foods and beverages. Analyzed in Poisson regression with robust SE to directly estimate risk ratios.
Within approximately 5 minutes of intervention exposure
Correct assessment of "high" nutrients
Time Frame: Within approximately 5 minutes of intervention exposure
Participants will view 4 foods and indicate whether each food is high in each of saturated fat, sodium, and added sugar. A "correct" response is identifying a high-in product as high in the corresponding nutrient and identifying a not high-in product as not high in the corresponding nutrient; otherwise the response is "incorrect". Participants will provide 12 responses (3 nutrients across 4 foods), and the percent correct for each participant will be used as a continuous outcome in linear regression. If the distribution of percent correct is skewed, analysis may use all 12 dichotomous responses in a mixed model, accounting for within subject correlation. In sensitivity analyses, this outcome will be (1) examined by nutrient and (2) dichotomized as correct assessment of all nutrients in each meal.
Within approximately 5 minutes of intervention exposure

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Perceived message effectiveness
Time Frame: Within approximately 5 minutes of intervention exposure
Measured with one item from the validated 3-item University of North Carolina perceived message effectiveness scale: "How much does this label discourage you from wanting to consume products high in sodium, saturated fat, and added sugar?" Response options include 1-5 where higher values represent higher perceived discouragement. Analyzed as a continuous outcome in linear regression.
Within approximately 5 minutes of intervention exposure

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Jennifer Falbe, ScD, MPH, University of California, Davis

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 23, 2024

Primary Completion (Actual)

February 13, 2025

Study Completion (Actual)

February 13, 2025

Study Registration Dates

First Submitted

October 24, 2024

First Submitted That Met QC Criteria

November 1, 2024

First Posted (Actual)

November 5, 2024

Study Record Updates

Last Update Posted (Estimated)

June 25, 2025

Last Update Submitted That Met QC Criteria

June 19, 2025

Last Verified

June 1, 2025

More Information

Terms related to this study

Other Study ID Numbers

  • 1641776-8B

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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