Comparing Front-of-package Nutrient Labels

NCT ID: NCT06903403

Last Updated: 2025-06-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 15582 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-04-01
• Study Completion Date: 2025-04-25

Brief Summary

The goal of this study is to compare front-of-package labels to a no-label control and to one another: 1.) FDA's Nutrition Info with %DV, 2.) Nutrition Info with red "high", 3.) FDA's High In, 4.) multiple High In labels-one for each nutrient and 5.) a no-label control. Primary outcomes include 1.) correct identification of foods and beverages with the healthiest and least healthy overall nutrient profiles, 2.) perceived healthfulness of products low in two nutrients of concern, and 3.) correct identification of foods and beverages as high in saturated fat, sodium, and added sugars.

Detailed Description

The overall goal of this online randomized controlled trial is to compare the performance of FDA's Nutrition Info %DV front-of-package label (FOPL) to a no-label control and other FOPL designs, including the Nutrition Info label without the %DV and with red color for "high in" nutrients, the FDA's High In label, and multiple black box High In labels-one for each nutrient.

The primary outcomes are: 1.) correct identification of foods and beverages with the healthiest and least healthy overall nutrient profiles, 2.) perceived healthfulness of products low in two nutrients of concern, and 3.) correct identification of foods and beverages as high in saturated fat, sodium, and added sugars. Secondary outcomes include: 1.) noticing the nutrition label, 2.) recalling the label's content, 3.) reported use of label when selecting food items, 4.) perceived healthfulness of i.) products not high in any nutrients of concern and ii.) products with different nutrient levels for each nutrient of concern, 5.) selection of a food item high in at least one nutrient of concern for themselves, 6.) selection of a food item high in at least one nutrient of concern for their youngest child (at least 2 years old), 7.) perceived message effectiveness of label for discouraging consumption of foods high in saturated fat, sodium, and added sugars, 8.) time spent on identifying healthiest and least healthy overall nutrient profiles, and 9.) time spent on identifying foods and beverages as high in saturated fat, sodium, and added sugars.

Repeated dichotomous outcomes (e.g., correct selection of healthiest profile, correct selection of least healthy profile, correct identification of product high in nutrients of concern) will be analyzed in mixed effects Poisson regression with robust standard errors. Single dichotomous outcomes (e.g., noticing, use of label, selection of at least one item high in one nutrient of concern) will be analyzed in Poisson regression with robust standard errors. Results will report proportions in each condition and absolute (i.e., percentage point) and relative differences (i.e., probability ratios). Continuous outcomes (e.g., perceived healthfulness, time spent) will be used in linear regression. All regression models will regress the outcome on an indicator for experimental condition. results will report averages by condition and average differential effects between conditions. Analyses will use a two-sided critical alpha of 0.05 to conduct all statistical tests. All confidence intervals presented will be 95% and two-sided. Given the preliminary nature of this study, which is comparing novel FOPLs for the first time, no p-value adjustments for multiple comparisons are planned.

In moderation analyses using interaction terms and stratified models, effect modification of label design on the primary outcomes will be examined by participant nutrition literacy, education, grocery shopping frequency, having children, and type of device used to take the survey.

Additionally, differences in all outcomes between each of the 5 unique conditions will be examined. The modeling approach may be modified if assumptions are not met.

A soft launch of approximately 500 completed surveys will be conducted to verify that the online survey is functioning as intended and to detect any programming errors. There may be another soft launch if any corrections are needed. If the target sample size is not achieved by April 30th, 2025, the data collected thus far will be used in preliminary analysis to provide public comments. The analytic sample will include participants with complete data on the primary outcomes.

Conditions

Nutrition Knowledge; Perceptions; Dietary Behavior

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• 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

Nutrition Info 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 Value per serving, "medium" as 6-19%, and "low" as 5% or less. The label will also list the percent 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

Nutrition Info with Red "High"

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 Value per serving, "medium" as 6-19%, and "low" as 5% or less. The label will have a white background and black text, except for the word "high," which will be in white font and highlighted red.

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

Plain High In

Participants will see packaged food and beverage items displaying front-of-package labels that say, "High In \[nutrient\]" (nutrients: saturated fat, sodium, and/or added sugars) if the item contains 20% or more of the Daily Value 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

Multiple Black Box High In

Participants will see packaged food and beverage items displaying front-of-package labels that say, "High In \[nutrient\]" (nutrients: saturated fat, sodium, and/or added sugars) if the item contains 20% or more of the Daily Value per serving for each nutrient. Each nutrient will have it's own label, a black box with white text. If the item is not high in a nutrient, it will not display the black box label for that nutrient. If the item is not high in any of the 3 nutrients, the product will not display any labels.

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

Exclusion Criteria

• Failing the attention check question
• Completing the survey in less than one-third of the median completion time (median time calculated when 90% of responses are collected and will be based on the median time of completed questionnaires)

• 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

Role: PRINCIPAL_INVESTIGATOR

University of California, Davis

Locations

University of California, Davis

Davis, California, United States

Countries

United States

Other Identifiers

2295549

Identifier Type: -

Identifier Source: org_study_id