Understanding of Food Nutrient ContentNCT06227507
High in Front-of-package Label Pretest
A study testing Front-of-package label in people with Understanding of Food Nutrient Content, run by University of California, Davis at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 99 yearsHealthy volunteers can take part
- Conditions the study is for
- Understanding of Food Nutrient Content
- What is being tested?
- Front-of-package label
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4,052 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Feb 2024to 15 Mar 2024
- 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
- 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
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, 95616
About this study
Official title: 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).
Read the 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).
- Conditions
- Understanding of Food Nutrient Content
- 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 labelBehavioural
Participants will identify the healthfulness of three packaged foods, each displayed with front-of-package labels as specified by their assigned group.
| Study group | Role | What they receive |
|---|---|---|
| No icon | Experimental | 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. Receives: Behavioral: Front-of-package label |
| Magnifying glass | Experimental | 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. Receives: Behavioral: Front-of-package label |
| Exclamation Mark | Experimental | 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. Receives: Behavioral: Front-of-package label |
| Exclamation Mark with multiple labels | Experimental | 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. Receives: Behavioral: Front-of-package label |
| Exclamation Mark with Black Background | Experimental | 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. Receives: Behavioral: Front-of-package label |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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)
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."
Measured: 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."
Measured: 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."
Measured: 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."
Measured: 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.
Measured: During a ~10 minute online survey
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2024
- Study start15 Feb 2024
- Primary completion15 Mar 2024
- Study completion15 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Understanding of Food Nutrient ContentStudies 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
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 4,052 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Davis
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jennifer Falbe, ScD, MPH, Principal investigator, University of California, Davis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06227507
- Sponsor's protocol ID
- 1641776-7
- Status last verified
- Jan 2024
- First submitted
- 8 Jan 2024
- Last updated
- 9 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Lemmon B, Musicus AA, Grummon AH, Hall MG, Roberto CA, Greenthal E, Falbe J. "High-In" front-of-package labeling of foods high in added sugars, sodium, and saturated fat: A randomized experiment. Appetite. 2026 Jan 1;216:108308. doi: 10.1016/j.appet.2025.108308. Epub 2025 Sep 17.
PubMed 40972965
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- FDA Front-of-package Pretest: High In Labels
- ClinicalTrials.gov ID
- NCT06227507
- Acronym / sponsor ID
- 1641776-7
- Conditions
- Understanding of Food Nutrient Content
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 4,052 participants (actual)
- Lead sponsor
- University of California, DavisUniversity, hospital or other
- Study start
- 15 Feb 2024 (actual)
- Primary completion
- 15 Mar 2024 (actual)
- Study completion
- 15 Mar 2024 (actual)
- First posted
- 29 Jan 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.
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).
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| No icon | Experimental | Behavioral: Front-of-package labelParticipants 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 | Experimental | Behavioral: Front-of-package labelParticipants 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 | Experimental | Behavioral: Front-of-package labelParticipants 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 | Experimental | Behavioral: Front-of-package labelParticipants 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 | Experimental | Behavioral: Front-of-package labelParticipants 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. |
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
- 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
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 identify the healthfulness of three packaged foods, each displayed with front-of-package labels as specified by their assigned group. | Behavioural | Exclamation Mark, Exclamation Mark with Black Background, Exclamation Mark with multiple labels, Magnifying glass, No icon |
Primary outcome
Identification of healthiest product - dichotomous variable "Correct" (Selected product that is high in only 1 nutrient of concern) or "Incorrect" (otherwise)
Time frame: During a ~10 minute online survey
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.
5 secondary outcomes
Identification of least healthy product - dichotomous variable "Correct" (Selected product that is high in all 3 nutrients of concern) or "Incorrect" (otherwise)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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
Time frame: During a ~10 minute online survey
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 9 May 2024.
- Derived from this study: PubMed 40972965Lemmon B, Musicus AA, Grummon AH, Hall MG, Roberto CA, Greenthal E, Falbe J. "High-In" front-of-package labeling of foods high in added sugars, sodium, and saturated fat: A randomized experiment. Appetite. 2026 Jan 1;216:108308. doi: 10.1016/j.appet.2025.108308. Epub 2025 Sep 17.
- Individual participant dataSharing planned: No
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 Understanding of Food Nutrient Content, 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 9 May 2024. 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?
Identification of healthiest product - dichotomous variable "Correct" (Selected product that is high in only 1 nutrient of concern) or "Incorrect" (otherwise) (time frame: During a ~10 minute online survey). 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 NCT06227507, 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 9 May 2024.