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Nutrition KnowledgeNCT06903403

Comparing Front-of-package Nutrient Labels

A study testing Front-of-package label in people with Nutrition Knowledge and Perceptions, run by University of California, Davis at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 99 yearsHealthy volunteers can take part
Conditions the study is for
Nutrition Knowledge, Perceptions, Dietary Behavior
What is being tested?
Front-of-package label
Could I receive a placebo?
No, everyone receives an active treatment
How many people
15,582 participants
Where
1 siteUnited States
Study dates
1 Apr 2025to 25 Apr 2025
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 99 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • 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)

Trial locations and contacts

1 site in 1 country.

United States1 site
  • University of California, Davis

    Davis, California, 95616

Other trials in United States

About this study

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.

Read the detailed description

The overall goal of this online randomized controlled trial is to compare the performance of FDA's Nutrition Info %DV front-of-package label (FOPL) to a no-label control and other FOPL designs, including the Nutrition Info label without the %DV and with red color for "high in" nutrients, the FDA's High In label, and multiple black box High In labels-one for each nutrient.

The primary outcomes are: 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. Secondary outcomes include: 1.) noticing the nutrition label, 2.) recalling the label's content, 3.) reported use of label when selecting food items, 4.) perceived healthfulness of i.) products not high in any nutrients of concern and ii.) products with different nutrient levels for each nutrient of concern, 5.) selection of a food item high in at least one nutrient of concern for themselves, 6.) selection of a food item high in at least one nutrient of concern for their youngest child (at least 2 years old), 7.) perceived message effectiveness of label for discouraging consumption of foods high in saturated fat, sodium, and added sugars, 8.) time spent on identifying healthiest and least healthy overall nutrient profiles, and 9.) time spent on identifying foods and beverages as high in saturated fat, sodium, and added sugars.

Repeated dichotomous outcomes (e.g., correct selection of healthiest profile, correct selection of least healthy profile, correct identification of product high in nutrients of concern) will be analyzed in mixed effects Poisson regression with robust standard errors. Single dichotomous outcomes (e.g., noticing, use of label, selection of at least one item high in one nutrient of concern) will be analyzed in Poisson regression with robust standard errors. Results will report proportions in each condition and absolute (i.e., percentage point) and relative differences (i.e., probability ratios). Continuous outcomes (e.g., perceived healthfulness, time spent) will be used in linear regression. All regression models will regress the outcome on an indicator for experimental condition. results will report averages by condition and average differential effects between conditions. Analyses will use a two-sided critical alpha of 0.05 to conduct all statistical tests. All confidence intervals presented will be 95% and two-sided. Given the preliminary nature of this study, which is comparing novel FOPLs for the first time, no p-value adjustments for multiple comparisons are planned.

In moderation analyses using interaction terms and stratified models, effect modification of label design on the primary outcomes will be examined by participant nutrition literacy, education, grocery shopping frequency, having children, and type of device used to take the survey.

Additionally, differences in all outcomes between each of the 5 unique conditions will be examined. The modeling approach may be modified if assumptions are not met.

A soft launch of approximately 500 completed surveys will be conducted to verify that the online survey is functioning as intended and to detect any programming errors. There may be another soft launch if any corrections are needed. If the target sample size is not achieved by April 30th, 2025, the data collected thus far will be used in preliminary analysis to provide public comments. The analytic sample will include participants with complete data on the primary outcomes.

Being tested
Front-of-package label

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Front-of-package labelOther

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

Study groups in NCT06903403
Study groupRoleWhat they receive
No-label ControlNo interventionParticipants will see packaged food and beverage items with no front-of-package labels (other than any posted by the manufacturer).
Nutrition Info Percent Daily ValueExperimentalParticipants 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.
Receives: Other: Front-of-package label
Nutrition Info with Red "High"ExperimentalParticipants 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.
Receives: Other: Front-of-package label
Plain High InExperimentalParticipants 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.
Receives: Other: Front-of-package label
Multiple Black Box High InExperimentalParticipants 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.
Receives: Other: Front-of-package label

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Within approximately 5 minutes of intervention exposure

  2. 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.

    Measured: Within approximately 5 minutes of intervention exposure

  3. 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.

    Measured: Within approximately 5 minutes of intervention exposure

  4. 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.

    Measured: Within approximately 5 minutes of intervention exposure

Secondary outcomes (9)
  1. Noticing the label

    After a hypothetical shopping task (the first of two shopping tasks), participants will be asked if they noticed any nutrition labels on the food. Analysis will include using the dichotomous outcome of noticing in Poisson regression with robust standard errors.

    Measured: Within approximately 5 minutes of intervention exposure

  2. Recalling the label's content

    If participants answer "yes" to noticing a nutrition label, they will be asked, "What information was on the label? Select all that apply." Response options will include calories, fiber, saturated fat, sodium, added sugars, cholesterol, protein, calcium, vitamin D, and "none of these". The percent of options correctly selected or not selected will be used in linear regression.

    Measured: Within approximately 5 minutes of intervention exposure

  3. Reported use of label

    After a hypothetical shopping task (the first of two shopping tasks), if a participant responds "yes" to noticing a label, they will be asked if they used the label when selecting their item. Outcome will be dichotomized and analyzed in Poisson regression.

    Measured: Within approximately 5 minutes of intervention exposure

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

    Participants will provide a healthfulness score (response scale from 1-7) for 5 different products. The score for each product will be used as a continuous outcome in linear regression models.

    Measured: Within approximately 5 minutes of intervention exposure

  5. Selection of a product high in a nutrient of concern for themselves

    In the second of two shopping tasks, participants will select a food they would purchase for themselves from hypothetical grocery store shelves. 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), analyzed in Poisson regression with robust SE to directly estimate probability ratios.

    Measured: Within approximately 5 minutes of intervention exposure

  6. Selection of a product high in a nutrient of concern for their child

    Participants will select a food they would purchase for their youngest child (at least 2 years old) from hypothetical grocery store shelves. 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), analyzed in Poisson regression with robust SE to directly estimate probability ratios.

    Measured: Within approximately 5 minutes of intervention exposure

  7. Perceived message effectiveness

    Participants not in the control group will view their assigned label in isolation (i.e., not on a product) and will be asked "How much does this label discourage you from wanting to purchase foods or beverages that are high in saturated fat, sodium, or added sugars?" Response options will range from not at all (1) to a great deal (5). The responses will be treated as a continuous outcome in linear regression.

    Measured: Within approximately 5 minutes of intervention exposure

  8. Time spent on identifying healthiest and least healthy overall nutrient profiles

    Timer features will be used in the survey to measure the time spent on the primary outcome of identifying healthiest and least healthy overall nutrient profiles. The time (in seconds) will be used as a continuous outcome in linear regression. The top and bottom 2% will be considered outliers and excluded.

    Measured: Within approximately 5 minutes of intervention exposure

  9. Time spent on identifying foods and beverages as high in saturated fat, sodium, and added sugars.

    Timer features will be used in the survey to measure the time spent on the primary outcome of identifying foods and beverages as high in saturated fat, sodium, and added sugars. The time (in seconds) will be used as a continuous outcome in linear regression. The top and bottom 2% will be considered outliers and excluded.

    Measured: Within approximately 5 minutes of intervention exposure

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Mar 2025
  2. Study start1 Apr 2025
  3. Primary completion25 Apr 2025
  4. Study completion25 Apr 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Investigator
Enrolment
15,582 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06903403
Sponsor's protocol ID
2295549
Status last verified
Jun 2025
First submitted
24 Mar 2025
Last updated
25 Jun 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Lemmon B, Grummon AH, Marquez A, Soederberg Miller LM, Au LE, Brown SD, Wang A, Powell LM, Falbe J. Efficacy of front-of-package nutrient labels designed for mandatory implementation in the USA: an online randomised controlled trial. Lancet Public Health. 2026 Apr;11(4):e221-e232. doi: 10.1016/S2468-2667(26)00027-7.

    PubMed 41887825

Questions about this trial

What is this clinical trial studying?

A study testing Front-of-package label in people with Nutrition Knowledge and Perceptions, run by University of California, Davis at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 25 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Correct identification of healthiest profile (time frame: Within approximately 5 minutes of intervention exposure). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06903403, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jun 2025.

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