High in Front-of-package Label Pretest

FDA Front-of-package Pretest: High In Labels

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).

Study Overview

• Status: Completed
• Conditions: Understanding of Food Nutrient Content
• Intervention / Treatment: Behavioral: Front-of-package label

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).

• Study Type: Interventional
• Enrollment (Actual): 4052
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Davis, California, United States, 95616
      • University of California, Davis

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

5

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: No icon; Participants will be shown 3 frozen meals at once; each product will be high in 1, 2, or 3 nutrients of concern (added sugar, sodium, and/or saturated fat) and will be labeled as such with a rectangular "high in" front-of-package label. The label will solely contain "high in" and nutrient text with no icon.	Behavioral: Front-of-package label; Participants will identify the healthfulness of three packaged foods, each displayed with front-of-package labels as specified by their assigned group.
Experimental: Magnifying glass; Participants will be shown 3 frozen meals at once; each product will be high in 1, 2, or 3 nutrients of concern (added sugar, sodium, and/or saturated fat) and will be labeled as such with a rectangular "high in" front-of-package label. The label will contain "high in" and nutrient text, along with a magnifying glass icon.	Behavioral: Front-of-package label; Participants will identify the healthfulness of three packaged foods, each displayed with front-of-package labels as specified by their assigned group.
Experimental: Exclamation Mark; Participants will be shown 3 frozen meals at once; each product will be high in 1, 2, or 3 nutrients of concern (added sugar, sodium, and/or saturated fat) and will be labeled as such with a rectangular "high in" front-of-package label. The label will contain "high in" and nutrient text, along with an exclamation mark icon.	Behavioral: Front-of-package label; Participants will identify the healthfulness of three packaged foods, each displayed with front-of-package labels as specified by their assigned group.
Experimental: Exclamation Mark with multiple labels; Participants will be shown 3 frozen meals at once; each product will be high in 1, 2, or 3 nutrients of concern (added sugar, sodium, and/or saturated fat) and will be labeled as such with 1, 2, or 3 rectangular "high in" front-of-package labels, one for each specific nutrient of concern. Each label will contain "high in" and nutrient text, along with an exclamation mark icon.	Behavioral: Front-of-package label; Participants will identify the healthfulness of three packaged foods, each displayed with front-of-package labels as specified by their assigned group.
Experimental: Exclamation Mark with Black Background; Participants will be shown 3 frozen meals at once; each product will be high in 1, 2, or 3 nutrients of concern (added sugar, sodium, and/or saturated fat) and will be labeled as such with a rectangular "high in" front-of-package label. The label will contain "high in" and nutrient text, along with an exclamation mark icon. The background of the "high in" text will be black, and the "high in" text will be white.	Behavioral: Front-of-package label; Participants will identify the healthfulness of three packaged foods, each displayed with front-of-package labels as specified by their assigned group.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Identification of healthiest product - dichotomous variable "Correct" (Selected product that is high in only 1 nutrient of concern) or "Incorrect" (otherwise)	Measured 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.	During a ~10 minute online survey

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Identification of least healthy product - dichotomous variable "Correct" (Selected product that is high in all 3 nutrients of concern) or "Incorrect" (otherwise)	Measured 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."	During a ~10 minute online survey
Identification of high-sodium product(s) - dichotomous variable "Correct" (Selected all products that are high in sodium) or "Incorrect" (otherwise)	Measured with: "Which product(s) below are high in sodium? Select all that apply."	During a ~10 minute online survey
Identification of high-saturated-fat product(s) - dichotomous variable "Correct" (Selected all products that are high in saturated fat) or "Incorrect" (otherwise)	Measured with: "Which product(s) below are high in saturated fat? Select all that apply."	During a ~10 minute online survey
Identification of high-added-sugars product(s) - dichotomous variable "Correct" (Selected all products that are high in added sugars) or "Incorrect" (otherwise)	Measured with: "Which product(s) below are high in added sugars? Select all that apply."	During a ~10 minute online survey
Perceived Message Effectiveness of label: Discouragement - continuous variable from a 3-item scale in which each item uses a 1-5 response scale	Measured 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.	During a ~10 minute online survey

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Nutrition literacy	Measured 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	During a ~10 minute online survey

Collaborators and Investigators

• Sponsor: University of California, Davis
• Investigators: Principal Investigator: Jennifer Falbe, ScD, MPH, University of California, Davis

Study record dates

Study Major Dates

• Study Start (Actual): February 15, 2024
• Primary Completion (Actual): March 15, 2024
• Study Completion (Actual): March 15, 2024

Study Registration Dates

• First Submitted: January 8, 2024
• First Submitted That Met QC Criteria: January 24, 2024
• First Posted (Actual): January 29, 2024

Study Record Updates

• Last Update Posted (Actual): May 9, 2024
• Last Update Submitted That Met QC Criteria: May 7, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: 1641776-7

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No