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Completed

NCT Number: NCT06673706

Assessing the Impact of Front-of-package Nutrient Labels

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.

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Key information

Conditions

Nutrition Knowledge Attitudes Behavior Behavior, Animal Dietary Behavior Dietary Habits Feeding Behavior

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of California, Davis

Davis, California, 96516, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Front-of-package label

Other

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

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

Secondary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

University of California, Davis

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Nov 5, 2024
Registry last updated
Jun 25, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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