Assessing the Impact of Front-of-package Nutrient Labels

NCT ID: NCT06673706

Last Updated: 2025-06-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 10601 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-12-23
• Study Completion Date: 2025-02-13

Brief Summary

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.

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.

Conditions

Nutrition Knowledge; Attitudes; Dietary Habits; Dietary Behavior

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: FACTORIAL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

No-label Control

Participants will see packaged food-and-beverage items with no front-of-package labels (other than any posted by the manufacturer).

Group Type: NO_INTERVENTION

No interventions assigned to this group

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.

Group Type: EXPERIMENTAL

Front-of-package label

Intervention Type: OTHER

Participants will see packaged food-and-beverage items displayed with labels as specified by their assigned group

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.

Group Type: EXPERIMENTAL

Front-of-package label

Intervention Type: OTHER

Participants will see packaged food-and-beverage items displayed with labels as specified by their assigned group

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.

Group Type: EXPERIMENTAL

Front-of-package label

Intervention Type: OTHER

Participants will see packaged food-and-beverage items displayed with labels as specified by their assigned group

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.

Group Type: EXPERIMENTAL

Front-of-package label

Intervention Type: OTHER

Participants will see packaged food-and-beverage items displayed with labels as specified by their assigned group

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.

Group Type: EXPERIMENTAL

Front-of-package label

Intervention Type: OTHER

Participants will see packaged food-and-beverage items displayed with labels as specified by their assigned group

Interventions

Front-of-package label

Participants will see packaged food-and-beverage items displayed with labels as specified by their assigned group

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 99 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of California, Davis

OTHER

Sponsor Role: lead

Responsible Party

Jennifer Falbe

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jennifer Falbe, ScD, MPH

Role: PRINCIPAL_INVESTIGATOR

University of California, Davis

Locations

University of California, Davis

Davis, California, United States

Countries

United States

Other Identifiers

1641776-8B

Identifier Type: -

Identifier Source: org_study_id