Assessing the Impact of Front-of-package Nutrient Labels

Not Applicable

• Conditions: Nutrition Knowledge; Dietary Habits; Attitudes; Dietary Behavior

• Registration Number: NCT06673706
• Lead Sponsor: University of California, Davis

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.

Study Timeline

• Study First Submitted: 2024-10-24
• Study First Submitted QC: 2024-11-01
• Study First Posted: 2024-11-05
• Study Start: 2024-12-23
• Status Verified: 2025-01
• Last Update Submitted: 2025-03-27
• Primary Completion: 2025-04
• Last Update Posted: 2025-04-02
• Study Completion: 2025-10

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 10000

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Primary Outcome Measures

Name	Time	Method
Correct assessment of "high" nutrients	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.
Perceived healthfulness	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.
Selection of a product high in a nutrient of concern	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.

Secondary Outcome Measures

Name	Time	Method
Perceived message effectiveness	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.

Trial Locations

Locations (1)

University of California, Davis; 🇺🇸 Davis, California, United States