Nutrition KnowledgeNCT06673706
Assessing the Impact of Front-of-package Nutrient Labels
A study testing Front-of-package label in people with Nutrition Knowledge and Attitudes, run by University of California, Davis at 1 site in United States.
Trial summary
This study aims to compare different front-of-package label designs, using two schemes: (1) High In and (2) Nutrition Info with each scheme having (1) a version with colors (i.e., green, yellow, and/or red) indicating level of nutrient content and (2) a black-and-white version. 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, Attitudes, Dietary Habits
- What is being tested?
- Front-of-package label
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10,601 participants
- Where
- 1 siteUnited States
- Study dates
- 23 Dec 2024to 13 Feb 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
- Have eaten restaurant food at least once in the last month
- Participants will reflect the U.S. Census Bureau's 2021 American Community Survey 5-year estimates for gender, race/ethnicity, educational attainment, and age
Who cannot join
- Failing the attention check question
- Completing the survey in less than 33% of the median completion time
Trial locations and contacts
1 site in 1 country.
United States1 site
University of California, Davis
Davis, California, 96516
About this study
Official title: Assessing the Impact of Front-of-package Nutrient Labels on Consumer Understanding and Behavior
This study aims to compare different front-of-package label designs, using two schemes: (1) High In and (2) Nutrition Info with each scheme having (1) a version with colors (i.e., green, yellow, and/or red) indicating level of nutrient content and (2) a black-and-white version. Additionally the Nutrition Info scheme will have a version that includes the percent Daily Value in black and white. Labels will be compared against a no-label control and one another.
Read the detailed description
This study aims to compare different front-of-package label designs, using two schemes: (1) High In and (2) Nutrition Info. The labels will have variations, such as color, and will be compared to a no-label control and one another. There will be a total of 6 experimental conditions: 1) High In label with color; 2) High In label in black and white; 3) Nutrition Info label with color; 4) Nutrition Info in black and white; 5) Nutrition Info label in black and white with percent Daily Value listed; and 6) a no-label control.
Participants will view a series of food-and-beverage products labeled (or not) according to condition. The three primary outcomes are: (1) correct assessment of high nutrient contents in food-and-beverage products, (2) perceived healthfulness of packaged foods and beverages, and (3) selection of at least one item high in at least one nutrient of concern (saturated fat, sodium, added sugar) in a shopping task. Perceived message effectiveness will be examined as a secondary outcome.
All statistical analyses will use two-tailed tests with a significance level of <0.05. Per CONSORT Guidelines, all models comparing labels will be bivariate, regressing outcomes on indicators for labeling condition. For continuous outcomes, linear regression models will be used, and for dichotomous outcomes, risk ratios (or probability ratios) will be estimated using Poisson regression with a robust error variance.
Effect modification of the labels on primary outcomes will be explored for type 2 diabetes status and sociodemographic variables important for health equity using interaction terms and stratified models.
Additionally, differences in the primary outcomes between each of the 6 unique conditions will be explored.
- Conditions
- Nutrition Knowledge, Attitudes, Dietary Habits, Dietary Behavior
- Being tested
- Front-of-package label
- Medical subject headings
- Behavior, Feeding Behavior
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 group | Role | What they receive |
|---|---|---|
| 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). |
| High-In with color | Experimental | Participants will see packaged food-and-beverage items displaying front-of-package labels that say, "High In [nutrient]" (nutrients: saturated fat, sodium, or added sugar) if the item contains 20% or more of the daily recommended limit per serving for each nutrient. The nutrients will be highlighted in red.
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 |
| High-In black and white | Experimental | Participants will see packaged food-and-beverage items displaying front-of-package labels that say, "High In [nutrient]" (nutrients: saturated fat, sodium, or added sugar) if the item contains 20% or more of the daily recommended limit 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 |
| Nutrition Info with color | 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 recommended limit per serving, "medium" as 6-19%, and "low" as 5% or less. The word "high" will be highlighted red; the word "medium" will be highlighted yellow; and the word "low" will be highlighted green. Receives: Other: Front-of-package label |
| Nutrition Info black and white | 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 recommended limit per serving, "medium" as 6-19%, and "low" as 5% or less. The label will have a white background and black text. Receives: Other: Front-of-package label |
| Nutrition Info without color, with 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 recommended limit per serving, "medium" as 6-19%, and "low" as 5% or less. The label will also list the exact percent of the daily recommended limit (i.e., daily value) for each nutrient per serving. The label will have a white background and black text. Receives: Other: Front-of-package label |
What is being measured
The primary outcome is the main question the study is designed to answer.
Correct assessment of "high" nutrients
Participants will view 4 foods and indicate whether each food is high in each of saturated fat, sodium, and added sugar. 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". Participants will provide 12 responses (3 nutrients across 4 foods), and the percent correct for each participant will be used as a continuous outcome in linear regression. If the distribution of percent correct is skewed, analysis may use all 12 dichotomous responses in a mixed model, accounting for within subject correlation. In sensitivity analyses, this outcome will be (1) examined by nutrient and (2) dichotomized as correct assessment of all nutrients in each meal.
Measured: Within approximately 5 minutes of intervention exposure
Perceived healthfulness
Participants will provide a healthfulness score (response scale from 1-7) for up to 6 different products. The average score across products will be used as a continuous outcome in linear regression models. In sensitivity analyses, scores will be examined by product and product grouping.
Measured: Within approximately 5 minutes of intervention exposure
Selection of a product high in a nutrient of concern
Participants will select a food and beverage they would purchase for themselves from hypothetical grocery store shelves displaying foods and beverages. 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), examined overall and separately for foods and beverages. Analyzed in Poisson regression with robust SE to directly estimate risk ratios.
Measured: Within approximately 5 minutes of intervention exposure
Secondary outcomes (1)
Perceived message effectiveness
Measured with one item from the validated 3-item University of North Carolina perceived message effectiveness scale: "How much does this label discourage you from wanting to consume products high in sodium, saturated fat, and added sugar?" Response options include 1-5 where higher values represent higher perceived discouragement. Analyzed as a continuous outcome in linear regression.
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.
- First posted5 Nov 2024
- Study start23 Dec 2024
- Primary completion13 Feb 2025
- Study completion13 Feb 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nutrition KnowledgeStudies of the same condition, open and under way.
- More trials run by University of California, DavisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Factorial
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 10,601 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Davis
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jennifer Falbe, University of California, Davis
- Investigators
- Jennifer Falbe, ScD, MPH, Principal investigator, University of California, Davis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06673706
- Sponsor's protocol ID
- 1641776-8B
- Status last verified
- Jun 2025
- First submitted
- 24 Oct 2024
- Last updated
- 25 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessing the Impact of Front-of-package Nutrient Labels on Consumer Understanding and Behavior
- ClinicalTrials.gov ID
- NCT06673706
- Acronym / sponsor ID
- 1641776-8B
- Conditions
- Nutrition Knowledge, Attitudes, Dietary Habits, Dietary Behavior
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10,601 participants (actual)
- Lead sponsor
- University of California, DavisUniversity, hospital or other
- Study start
- 23 Dec 2024 (actual)
- Primary completion
- 13 Feb 2025 (actual)
- Study completion
- 13 Feb 2025 (actual)
- First posted
- 5 Nov 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study aims to compare different front-of-package label designs, using two schemes: (1) High In and (2) Nutrition Info with each scheme having (1) a version with colors (i.e., green, yellow, and/or red) indicating level of nutrient content and (2) a black-and-white version. Additionally the Nutrition Info scheme will have a version that includes the percent Daily Value in black and white. Labels will be compared against a no-label control and one another.
Detailed description
This study aims to compare different front-of-package label designs, using two schemes: (1) High In and (2) Nutrition Info. The labels will have variations, such as color, and will be compared to a no-label control and one another. There will be a total of 6 experimental conditions: 1) High In label with color; 2) High In label in black and white; 3) Nutrition Info label with color; 4) Nutrition Info in black and white; 5) Nutrition Info label in black and white with percent Daily Value listed; and 6) a no-label control.
Participants will view a series of food-and-beverage products labeled (or not) according to condition. The three primary outcomes are: (1) correct assessment of high nutrient contents in food-and-beverage products, (2) perceived healthfulness of packaged foods and beverages, and (3) selection of at least one item high in at least one nutrient of concern (saturated fat, sodium, added sugar) in a shopping task. Perceived message effectiveness will be examined as a secondary outcome.
All statistical analyses will use two-tailed tests with a significance level of <0.05. Per CONSORT Guidelines, all models comparing labels will be bivariate, regressing outcomes on indicators for labeling condition. For continuous outcomes, linear regression models will be used, and for dichotomous outcomes, risk ratios (or probability ratios) will be estimated using Poisson regression with a robust error variance.
Effect modification of the labels on primary outcomes will be explored for type 2 diabetes status and sociodemographic variables important for health equity using interaction terms and stratified models.
Additionally, differences in the primary outcomes between each of the 6 unique conditions will be explored.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (investigator)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| 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). |
| High-In with color | Experimental | Other: Front-of-package labelParticipants will see packaged food-and-beverage items displaying front-of-package labels that say, "High In [nutrient]" (nutrients: saturated fat, sodium, or added sugar) if the item contains 20% or more of the daily recommended limit per serving for each nutrient. The nutrients will be highlighted in red. 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. |
| High-In black and white | Experimental | Other: Front-of-package labelParticipants will see packaged food-and-beverage items displaying front-of-package labels that say, "High In [nutrient]" (nutrients: saturated fat, sodium, or added sugar) if the item contains 20% or more of the daily recommended limit 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. |
| Nutrition Info with color | Experimental | Other: Front-of-package labelParticipants 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 recommended limit per serving, "medium" as 6-19%, and "low" as 5% or less. The word "high" will be highlighted red; the word "medium" will be highlighted yellow; and the word "low" will be highlighted green. |
| Nutrition Info black and white | Experimental | Other: Front-of-package labelParticipants 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 recommended limit per serving, "medium" as 6-19%, and "low" as 5% or less. The label will have a white background and black text. |
| Nutrition Info without color, with percent Daily Value | Experimental | Other: Front-of-package labelParticipants 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 recommended limit per serving, "medium" as 6-19%, and "low" as 5% or less. The label will also list the exact percent of the daily recommended limit (i.e., daily value) for each nutrient per serving. The label will have a white background and black text. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Equal or greater than 18 years of age
- English-speaking
- U.S. residents
- Have eaten restaurant food at least once in the last month
- Participants will reflect the U.S. Census Bureau's 2021 American Community Survey 5-year estimates for gender, race/ethnicity, educational attainment, and age
Key exclusion criteria (2 listed)
- Failing the attention check question
- Completing the survey in less than 33% of the median completion time
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Front-of-package labelParticipants will see packaged food-and-beverage items displayed with labels as specified by their assigned group | Other | High-In black and white, High-In with color, Nutrition Info black and white, Nutrition Info with color, Nutrition Info without color, with percent Daily Value |
Primary outcome
Correct assessment of "high" nutrients
Time frame: Within approximately 5 minutes of intervention exposure
Participants will view 4 foods and indicate whether each food is high in each of saturated fat, sodium, and added sugar. 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". Participants will provide 12 responses (3 nutrients across 4 foods), and the percent correct for each participant will be used as a continuous outcome in linear regression. If the distribution of percent correct is skewed, analysis may use all 12 dichotomous responses in a mixed model, accounting for within subject correlation. In sensitivity analyses, this outcome will be (1) examined by nutrient and (2) dichotomized as correct assessment of all nutrients in each meal.
Perceived healthfulness
Time frame: Within approximately 5 minutes of intervention exposure
Participants will provide a healthfulness score (response scale from 1-7) for up to 6 different products. The average score across products will be used as a continuous outcome in linear regression models. In sensitivity analyses, scores will be examined by product and product grouping.
Selection of a product high in a nutrient of concern
Time frame: Within approximately 5 minutes of intervention exposure
Participants will select a food and beverage they would purchase for themselves from hypothetical grocery store shelves displaying foods and beverages. 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), examined overall and separately for foods and beverages. Analyzed in Poisson regression with robust SE to directly estimate risk ratios.
1 secondary outcome
Perceived message effectiveness
Time frame: Within approximately 5 minutes of intervention exposure
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jun 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jennifer Falbe, ScD, MPH principal investigator
University of California, Davis
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Front-of-package label in people with Nutrition Knowledge and Attitudes, 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 5 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 assessment of "high" nutrients (time frame: Within approximately 5 minutes of intervention exposure). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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.