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High in Front-of-package Label Pretest

FDA Front-of-package Pretest: High In Labels

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06227507
Enrollment
4052
Registered
2024-01-29
Start date
2024-02-15
Completion date
2024-03-15
Last updated
2024-05-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Understanding of Food Nutrient Content

Brief summary

The goal of this trial is to understand which of five High In front-of-package label designs is most effective at helping consumers identify the healthiest products (i.e., products that are high in the fewest number of nutrients of concern: added sugar, sodium, and saturated fat).

Detailed description

The objective of this aim is to assess which of five High In front-of-package label (FOPL) designs is most effective at helping consumers identify the healthiest products (i.e., products that are high in the fewest number of nutrients of concern: added sugar, sodium, and saturated fat). The investigators will use a between-subjects randomized experiment to assess the primary outcome. Participants will be randomized to one of five label conditions modeled after the U.S. Food and Drug Administration's draft High In FOPL designs: 1) No Icon; 2) Magnifying Glass; 3) Exclamation Mark; 4) Exclamation Mark with multiple labels; 5) Exclamation Mark with Black Background. The primary outcome is correct identification of the healthiest product, defined as the product that is high in the fewest nutrients of concern, including added sugars, sodium, and saturated fat (percent correct for each condition). Secondary outcomes include correct identification of which product is least healthy; which product(s) are high in added sugars, saturated fat, and sodium (3 separate questions); and perceived message effectiveness (PME) of the different labels. Logit models will be used to compare proportions in each condition that correctly identified the items (each condition compared to every other condition). For continuous outcomes (e.g., knowledge, PME scale), the investigators will use linear regression models regressing the outcome on an indicator for experimental condition. A critical alpha 0.05 will be used, and statistical tests will be two-tailed. The Bonferroni Holm correction will be used for analyses comparing conditions 2-5 to each other for each outcome (6 comparisons). The investigators will also measure nutrition literacy, and assess moderation on the primary outcome by nutrition literacy (continuous) and highest education attainment (Bachelor's Degree or higher vs. less than Bachelor's Degree).

Interventions

Participants will identify the healthfulness of three packaged foods, each displayed with front-of-package labels as specified by their assigned group.

Sponsors

University of California, Davis
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Investigator)

Eligibility

Sex/Gender
ALL
Age
18 Years to 99 Years
Healthy volunteers
Yes

Inclusion criteria

* Equal or greater than 18 years of age * Less than 100 years of age * English-speaking * U.S. residents * 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

Design outcomes

Primary

MeasureTime frameDescription
Identification of healthiest product - dichotomous variable Correct (Selected product that is high in only 1 nutrient of concern) or Incorrect (otherwise)During a ~10 minute online surveyMeasured with: Which of the products below is the healthiest in terms of added sugars, sodium, and saturated fat content? The U.S. Food and Drug Administration (FDA) recommends limiting consumption of added sugars, sodium, and saturated fat. There is no formal name for this measure/scale.

Secondary

MeasureTime frameDescription
Identification of high-added-sugars product(s) - dichotomous variable Correct (Selected all products that are high in added sugars) or Incorrect (otherwise)During a ~10 minute online surveyMeasured with: Which product(s) below are high in added sugars? Select all that apply.
Identification of least healthy product - dichotomous variable Correct (Selected product that is high in all 3 nutrients of concern) or Incorrect (otherwise)During a ~10 minute online surveyMeasured with: Which of the products below is the least healthy in terms of added sugars, sodium, and saturated fat content? The U.S. Food and Drug Administration (FDA) recommends limiting consumption of added sugars, sodium, and saturated fat.
Identification of high-saturated-fat product(s) - dichotomous variable Correct (Selected all products that are high in saturated fat) or Incorrect (otherwise)During a ~10 minute online surveyMeasured with: Which product(s) below are high in saturated fat? Select all that apply.
Perceived Message Effectiveness of label: Discouragement - continuous variable from a 3-item scale in which each item uses a 1-5 response scaleDuring a ~10 minute online surveyMeasured with discouragement item from University of North Carolina Perceived Message Effectiveness Scale: How much does this label discourage you from wanting to eat this product? Response options include Not at all, A little bit, Somewhat, Quite a bit, and A great deal.
Identification of high-sodium product(s) - dichotomous variable Correct (Selected all products that are high in sodium) or Incorrect (otherwise)During a ~10 minute online surveyMeasured with: Which product(s) below are high in sodium? Select all that apply.

Other

MeasureTime frameDescription
Nutrition literacyDuring a ~10 minute online surveyMeasured with: How confident are you that you understand Nutrition Facts labels? Below is an example of a Nutrition Facts label. \[Nutrition Facts label displayed\]. Response options include Not at all confident, A little confident, Somewhat confident, Very confident, and Extremely confident

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026