NCT06903403

Brief Summary

The goal of this study is to compare front-of-package labels to a no-label control and to one another: 1.) FDA's Nutrition Info with %DV, 2.) Nutrition Info with red "high", 3.) FDA's High In, 4.) multiple High In labels-one for each nutrient and 5.) a no-label control. Primary outcomes include 1.) correct identification of foods and beverages with the healthiest and least healthy overall nutrient profiles, 2.) perceived healthfulness of products low in two nutrients of concern, and 3.) correct identification of foods and beverages as high in saturated fat, sodium, and added sugars.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
15,582

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 24, 2025

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 30, 2025

Completed
2 days until next milestone

Study Start

First participant enrolled

April 1, 2025

Completed
24 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 25, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 25, 2025

Completed
Last Updated

June 25, 2025

Status Verified

June 1, 2025

Enrollment Period

24 days

First QC Date

March 24, 2025

Last Update Submit

June 19, 2025

Conditions

Outcome Measures

Primary Outcomes (4)

  • Correct identification of healthiest profile

    Participants will view 4 series of 3 products on the same screen, with each product having a nutrient profile. They will be instructed, "Choose the food \[beverage\] that has the healthiest overall nutrient profile. Consider saturated fat, sodium, and added sugars." Outcome for each series will be dichotomized (1 = correct, 0 = incorrect), and the multiple outcomes will be used in mixed effects Poisson regression with robust standard errors.

    Within approximately 5 minutes of intervention exposure

  • Correct identification of least healthy profile

    Participants will view approximately 4 series of 3 products side-by-side, showing different nutrient profiles. They will be asked "Choose the food \[or beverage\] with the least healthy overall nutrient profile. Consider saturated fat, sodium, and added sugars." Outcome for each series will be dichotomized (1 = correct, 0 = incorrect) and the multiple outcomes will be used in mixed effects Poisson regression with robust standard errors.

    Within approximately 5 minutes of intervention exposure

  • Correct identification of "high" nutrients

    Participants will view 5 foods and indicate whether each food is high in each of saturated fat, sodium, and added sugars. 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". The 15 (3 nutrients across 5 products) dichotomous responses will be analyzed in a mixed model, accounting for within subject correlation.

    Within approximately 5 minutes of intervention exposure

  • Perceived healthfulness of items low in two nutrients of concern

    Participants will provide a healthfulness score (response scale from 1-7 ranging from very unhealthy to very healthy) for 4 different products. The score for each product will be used as a continuous outcome in linear regression models.

    Within approximately 5 minutes of intervention exposure

Secondary Outcomes (9)

  • Noticing the label

    Within approximately 5 minutes of intervention exposure

  • Recalling the label's content

    Within approximately 5 minutes of intervention exposure

  • Reported use of label

    Within approximately 5 minutes of intervention exposure

  • Perceived healthfulness of (i) items not high in any nutrient of concern and (ii) items with different nutrient levels for each nutrient of concern

    Within approximately 5 minutes of intervention exposure

  • Selection of a product high in a nutrient of concern for themselves

    Within approximately 5 minutes of intervention exposure

  • +4 more secondary outcomes

Study Arms (5)

No-label Control

NO INTERVENTION

Participants will see packaged food and beverage items with no front-of-package labels (other than any posted by the manufacturer).

Nutrition Info Percent Daily Value

EXPERIMENTAL

Participants will see packaged food and beverage items displaying front-of-package labels that list "high", "medium", or "low" for saturated fat, sodium, and added sugars. "High" is defined as 20% or more of the Daily Value per serving, "medium" as 6-19%, and "low" as 5% or less. The label will also list the percent Daily Value for each nutrient per serving. The label will have a white background and black text.

Other: Front-of-package label

Nutrition Info with Red "High"

EXPERIMENTAL

Participants will see packaged food and beverage items displaying front-of-package labels that list "high", "medium", or "low" for saturated fat, sodium, and added sugars. "High" is defined as 20% or more of the Daily Value per serving, "medium" as 6-19%, and "low" as 5% or less. The label will have a white background and black text, except for the word "high," which will be in white font and highlighted red.

Other: Front-of-package label

Plain High In

EXPERIMENTAL

Participants will see packaged food and beverage items displaying front-of-package labels that say, "High In \[nutrient\]" (nutrients: saturated fat, sodium, and/or added sugars) if the item contains 20% or more of the Daily Value per serving for each nutrient. The label will have a white background and black text. If the item is not high in 1 or 2 of the nutrients, the nutrient(s) will not be on the label. If the item is not high in any of the 3 nutrients, the product will not display this label.

Other: Front-of-package label

Multiple Black Box High In

EXPERIMENTAL

Participants will see packaged food and beverage items displaying front-of-package labels that say, "High In \[nutrient\]" (nutrients: saturated fat, sodium, and/or added sugars) if the item contains 20% or more of the Daily Value per serving for each nutrient. Each nutrient will have it's own label, a black box with white text. If the item is not high in a nutrient, it will not display the black box label for that nutrient. If the item is not high in any of the 3 nutrients, the product will not display any labels.

Other: Front-of-package label

Interventions

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

Multiple Black Box High InNutrition Info Percent Daily ValueNutrition Info with Red "High"Plain High In

Eligibility Criteria

Age18 Years - 99 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Equal or greater than 18 years of age
  • English-speaking
  • U.S. residents

You may not qualify if:

  • Failing the attention check question
  • Completing the survey in less than one-third of the median completion time (median time calculated when 90% of responses are collected and will be based on the median time of completed questionnaires)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of California, Davis

Davis, California, 95616, United States

Location

Study Officials

  • Jennifer Falbe

    University of California, Davis

    PRINCIPAL INVESTIGATOR

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
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

March 24, 2025

First Posted

March 30, 2025

Study Start

April 1, 2025

Primary Completion

April 25, 2025

Study Completion

April 25, 2025

Last Updated

June 25, 2025

Record last verified: 2025-06

Data Sharing

IPD Sharing
Will not share

Locations