High in Front-of-package Label Pretest
FDA Front-of-package Pretest: High In Labels
1 other identifier
interventional
4,052
1 country
1
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Feb 2024
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 8, 2024
CompletedFirst Posted
Study publicly available on registry
January 29, 2024
CompletedStudy Start
First participant enrolled
February 15, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 15, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
March 15, 2024
CompletedMay 9, 2024
January 1, 2024
29 days
January 8, 2024
May 7, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (5)
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 survey
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 survey
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 survey
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 survey
Perceived Message Effectiveness of label: Discouragement - continuous variable from a 3-item scale in which each item uses a 1-5 response scale
During a ~10 minute online survey
Other Outcomes (1)
Nutrition literacy
During a ~10 minute online survey
Study Arms (5)
No icon
EXPERIMENTALParticipants 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.
Magnifying glass
EXPERIMENTALParticipants 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.
Exclamation Mark
EXPERIMENTALParticipants 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.
Exclamation Mark with multiple labels
EXPERIMENTALParticipants 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.
Exclamation Mark with Black Background
EXPERIMENTALParticipants 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.
Interventions
Participants will identify the healthfulness of three packaged foods, each displayed with front-of-package labels as specified by their assigned group.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Failing the attention check question
- Completing the survey in less than 33% of the median completion time
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of California, Davis
Davis, California, 95616, United States
Study Officials
- PRINCIPAL INVESTIGATOR
Jennifer Falbe, ScD, MPH
University of California, Davis
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- INVESTIGATOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 8, 2024
First Posted
January 29, 2024
Study Start
February 15, 2024
Primary Completion
March 15, 2024
Study Completion
March 15, 2024
Last Updated
May 9, 2024
Record last verified: 2024-01
Data Sharing
- IPD Sharing
- Will not share