Diet, HealthyNCT06293963
Front-of-package Label Effects in Latine and Limited English Proficiency Populations
A study testing Guideline Daily Amounts label, Interpretive text-only label and Interpretive magnifying glass icon label in people with Diet, Healthy, run by University of North Carolina, Chapel Hill at 1 site in United States.
Trial summary
The goal of this experiment is to examine the effects of 4 types of front-of-package food labels among a sample of Latino adults. The main questions this experiment aims to answer are: What front-of-package label design is most effective in helping Latino and low English proficiency consumers identify healthier and… Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Diet, Healthy
- What is being tested?
- Guideline Daily Amounts label, Interpretive text-only label and Interpretive magnifying glass icon label
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3,306 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Aug 2024to 11 Sep 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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Identifying as Latino or Hispanic
- Ages 18-55 years old
- Residing in US
Who cannot join
- Not identifying as Latino or Hispanic
- Less than 18 or greater than 55 years old
- Not residing in the United States
Trial locations and contacts
1 site in 1 country.
United States1 site
The University of North Carolina at Chapel Hill's Gillings School of Global Public Health
Chapel Hill, North Carolina, 27599
About this study
Official title: Centering Equity in FDA Regulation: Front-of-package Food Label Effects in Latine and Limited English Proficiency Populations
The goal of this experiment is to examine the effects of 4 types of front-of-package food labels among a sample of Latino adults. The main questions this experiment aims to answer are:
What front-of-package label design is most effective in helping Latino and low English proficiency consumers identify healthier and less healthy food products?
Read more
What front-of-package label design is most effective in helping Latino and low English proficiency consumers choose healthier food products?
Additionally, this experiment also aims to answer the following question:
Do the benefits of front-of-package label designs differ by English proficiency and parental status?
Participants will be randomly assigned to 1 of 4 types of front-of-package label designs and view their assigned label design on 3 sets of products. Each set will display 3 similar products, each high in either 1, 2, or 3 nutrients of concern. For each set, participants will select the product that they believe to be the healthiest, least healthy, and the product that they would most want to consume. Researchers will compare results across label designs.
Read the detailed description
This study aims to determine which front-of-package label design is most effective at helping Latino consumers identify and choose healthier products, as well as explore whether the benefits of different front-of-package label designs differ by English proficiency. A Latino-focused panel company will recruit 4,000 US Latino adults of parental age (18-55 years), approximately 50% of whom will have limited English proficiency.
In a between-subjects experiment, researchers will randomize participants to 1 of 4 types of front-of-package label designs: a numerical label, an interpretive text-only label, an interpretive label with a magnifying glass icon, or separated interpretive labels with a magnifying glass icon. Participants will view their assigned label design on 3 similar products (each product high in either 1, 2, or 3 nutrients of concern) and complete selection tasks. These tasks will be repeated 3 times, each time with a different type of product (i.e., frozen meals, frozen pizzas, and frozen desserts), with the products displayed in random order.
- Conditions
- Diet, Healthy
- Being tested
- Guideline Daily Amounts label, Interpretive text-only label, Interpretive magnifying glass icon label, Separated interpretive magnifying glass icon label
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Guideline Daily Amounts labelBehavioural
Labels that list the amount and percent of daily value of added sugar, sodium, or saturated fat, modeled after Guideline Daily Amounts labels.
Interpretive text-only labelBehavioural
Interpretive text-only labels that state when a product contains high amounts of added sugar, sodium, or saturated fat.
Interpretive magnifying glass icon labelBehavioural
Interpretive labels that state when a product contains high amounts of added sugar, sodium, or saturated fat, containing a magnifying glass icon.
Separated interpretive magnifying glass icon labelBehavioural
Interpretive labels that state when a product contains high amounts of added sugar, sodium, or saturated fat, containing a magnifying glass icon. Each nutrient will be on a separate label.
| Study group | Role | What they receive |
|---|---|---|
| Numerical label | Experimental | Not described Receives: Behavioral: Guideline Daily Amounts label |
| Interpretive text-only label | Experimental | Not described Receives: Behavioral: Interpretive text-only label |
| Interpretive magnifying glass icon label | Experimental | Not described Receives: Behavioral: Interpretive magnifying glass icon label |
| Separated interpretive magnifying glass icon label | Experimental | Not described Receives: Behavioral: Separated interpretive magnifying glass icon label |
What is being measured
The primary outcome is the main question the study is designed to answer.
Correct identification of healthiest product
Correct identification of healthiest product will be measured by survey. Responses will be coded in a dichotomous 0-1 range, where 1 indicates that the participant correctly identified the healthiest product and 0 indicates that the participant incorrectly identified one of the other two less healthy products as the healthiest product.
Measured: During exposure to intervention (i.e., study stimuli), assessed during one-time online 10-minute survey.
Correct identification of least healthy product
Correct identification of least healthy product will be measured by survey. Responses will be coded in a dichotomous 0-1 range, where 1 indicates that the participant correctly identified the least healthy product and 0 indicates that the participant incorrectly identified one of the other two healthier products as the least healthy product.
Measured: During exposure to intervention (i.e., study stimuli), assessed during one-time online 10-minute survey.
Secondary outcomes (2)
Correct identification of products high in nutrients
Correct identification of products high in nutrients (i.e., sugar, saturated fat, or sodium) will be measured by survey. Responses will be coded in a dichotomous 0-1 range, where 1 indicates that the participant correctly identified products that are high in a given nutrient and 0 indicates that the participant incorrectly identified products that are not high in a given nutrient as being high in such nutrient.
Measured: During exposure to intervention (i.e., study stimuli), assessed during one-time online 10-minute survey.
Selection of healthiest product for purchase
Selection of healthiest product for purchase will be measured by survey. Responses will be coded in a dichotomous 0-1 range, where 1 indicates that the participant chose the healthiest product and 0 indicates that the participants selected one of the other two less healthy products.
Measured: During exposure to intervention (i.e., study stimuli), assessed during one-time online 10-minute survey.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2024
- Study start9 Aug 2024
- Primary completion11 Sep 2024
- Study completion11 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Diet, HealthyStudies of the same condition, open and under way.
- More trials run by University of North Carolina, Chapel HillThe 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
- None (open label)
- Enrolment
- 3,306 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of North Carolina, Chapel Hill
- Sponsor type
- University, hospital or other
- Collaborators
- Duke University, Stanford University
- Responsible party
- Sponsor
- Investigators
- Marissa G Hall, PhD, Principal investigator, University of North Carolina, Chapel Hill
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06293963
- Sponsor's protocol ID
- 24-0300a
- Status last verified
- Oct 2024
- First submitted
- 27 Feb 2024
- Last updated
- 24 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The Study Protocol and Statistical Analysis Plan will be shared prior to data collection. After data collection and analysis, a de-identified version of individual participant data and the analytic code will be shared through the Open Science Framework (OSF).
Publications
Hall MG, Lee CJY, Campos AD, Serrano N, Taillie LS, Falbe J, Musicus AA, Whitesell C, Martinez AV, Grummon AH. An RCT of Front-Of-Package Nutrition Labels in Latino Populations in the U.S. Am J Prev Med. 2026 Mar;70(3):108122. doi: 10.1016/j.amepre.2025.108122. Epub 2025 Sep 20.
PubMed 40983259Hall MG, Lee CJY, Campos AD, Serrano N, Taillie LS, Falbe J, Musicus A, Whitesell C, Martinez AV, Grummon AH. Effects of front-of-package nutrition labels in Latine and limited English proficiency populations: A randomized trial. medRxiv [Preprint]. 2025 May 11:2025.05.09.25327177. doi: 10.1101/2025.05.09.25327177.
PubMed 40385392
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Centering Equity in FDA Regulation: Front-of-package Food Label Effects in Latine and Limited English Proficiency Populations
- ClinicalTrials.gov ID
- NCT06293963
- Acronym / sponsor ID
- 24-0300a
- Conditions
- Diet, Healthy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 3,306 participants (actual)
- Lead sponsor
- University of North Carolina, Chapel HillUniversity, hospital or other
- Collaborators
- Duke University, Stanford University
- Study start
- 9 Aug 2024 (actual)
- Primary completion
- 11 Sep 2024 (actual)
- Study completion
- 11 Sep 2024 (actual)
- First posted
- 5 Mar 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 experiment is to examine the effects of 4 types of front-of-package food labels among a sample of Latino adults. The main questions this experiment aims to answer are:
What front-of-package label design is most effective in helping Latino and low English proficiency consumers identify healthier and less healthy food products?
What front-of-package label design is most effective in helping Latino and low English proficiency consumers choose healthier food products?
Additionally, this experiment also aims to answer the following question:
Do the benefits of front-of-package label designs differ by English proficiency and parental status?
Participants will be randomly assigned to 1 of 4 types of front-of-package label designs and view their assigned label design on 3 sets of products. Each set will display 3 similar products, each high in either 1, 2, or 3 nutrients of concern. For each set, participants will select the product that they believe to be the healthiest, least healthy, and the product that they would most want to consume. Researchers will compare results across label designs.
Detailed description
This study aims to determine which front-of-package label design is most effective at helping Latino consumers identify and choose healthier products, as well as explore whether the benefits of different front-of-package label designs differ by English proficiency. A Latino-focused panel company will recruit 4,000 US Latino adults of parental age (18-55 years), approximately 50% of whom will have limited English proficiency.
In a between-subjects experiment, researchers will randomize participants to 1 of 4 types of front-of-package label designs: a numerical label, an interpretive text-only label, an interpretive label with a magnifying glass icon, or separated interpretive labels with a magnifying glass icon. Participants will view their assigned label design on 3 similar products (each product high in either 1, 2, or 3 nutrients of concern) and complete selection tasks. These tasks will be repeated 3 times, each time with a different type of product (i.e., frozen meals, frozen pizzas, and frozen desserts), with the products displayed in random order.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Numerical label | Experimental | Behavioral: Guideline Daily Amounts label |
| Interpretive text-only label | Experimental | Behavioral: Interpretive text-only label |
| Interpretive magnifying glass icon label | Experimental | Behavioral: Interpretive magnifying glass icon label |
| Separated interpretive magnifying glass icon label | Experimental | Behavioral: Separated interpretive magnifying glass icon label |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Identifying as Latino or Hispanic
- Ages 18-55 years old
- Residing in US
Key exclusion criteria (3 listed)
- Not identifying as Latino or Hispanic
- Less than 18 or greater than 55 years old
- Not residing in the United States
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 |
|---|---|---|
| Guideline Daily Amounts labelLabels that list the amount and percent of daily value of added sugar, sodium, or saturated fat, modeled after Guideline Daily Amounts labels. | Behavioural | Numerical label |
| Interpretive text-only labelInterpretive text-only labels that state when a product contains high amounts of added sugar, sodium, or saturated fat. | Behavioural | Interpretive text-only label |
| Interpretive magnifying glass icon labelInterpretive labels that state when a product contains high amounts of added sugar, sodium, or saturated fat, containing a magnifying glass icon. | Behavioural | Interpretive magnifying glass icon label |
| Separated interpretive magnifying glass icon labelInterpretive labels that state when a product contains high amounts of added sugar, sodium, or saturated fat, containing a magnifying glass icon. Each nutrient will be on a separate label. | Behavioural | Separated interpretive magnifying glass icon label |
Primary outcome
Correct identification of healthiest product
Time frame: During exposure to intervention (i.e., study stimuli), assessed during one-time online 10-minute survey.
Correct identification of healthiest product will be measured by survey. Responses will be coded in a dichotomous 0-1 range, where 1 indicates that the participant correctly identified the healthiest product and 0 indicates that the participant incorrectly identified one of the other two less healthy products as the healthiest product.
Correct identification of least healthy product
Time frame: During exposure to intervention (i.e., study stimuli), assessed during one-time online 10-minute survey.
Correct identification of least healthy product will be measured by survey. Responses will be coded in a dichotomous 0-1 range, where 1 indicates that the participant correctly identified the least healthy product and 0 indicates that the participant incorrectly identified one of the other two healthier products as the least healthy product.
2 secondary outcomes
Correct identification of products high in nutrients
Time frame: During exposure to intervention (i.e., study stimuli), assessed during one-time online 10-minute survey.
Selection of healthiest product for purchase
Time frame: During exposure to intervention (i.e., study stimuli), assessed during one-time online 10-minute 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 24 Apr 2025.
- Derived from this study: PubMed 40983259Hall MG, Lee CJY, Campos AD, Serrano N, Taillie LS, Falbe J, Musicus AA, Whitesell C, Martinez AV, Grummon AH. An RCT of Front-Of-Package Nutrition Labels in Latino Populations in the U.S. Am J Prev Med. 2026 Mar;70(3):108122. doi: 10.1016/j.amepre.2025.108122. Epub 2025 Sep 20.
- Derived from this study: PubMed 40385392Hall MG, Lee CJY, Campos AD, Serrano N, Taillie LS, Falbe J, Musicus A, Whitesell C, Martinez AV, Grummon AH. Effects of front-of-package nutrition labels in Latine and limited English proficiency populations: A randomized trial. medRxiv [Preprint]. 2025 May 11:2025.05.09.25327177. doi: 10.1101/2025.05.09.25327177.
- Individual participant dataSharing planned: Yes. The Study Protocol and Statistical Analysis Plan will be shared prior to data collection. After data collection and analysis, a de-identified version of individual participant data and the analytic code will be shared through the Open Science Framework (OSF).
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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.
Marissa G Hall, PhD principal investigator
University of North Carolina, Chapel Hill
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Guideline Daily Amounts label, Interpretive text-only label and Interpretive magnifying glass icon label in people with Diet, Healthy, run by University of North Carolina, Chapel Hill 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 3 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 24 Apr 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 product (time frame: During exposure to intervention (i.e., study stimuli), assessed during one-time online 10-minute survey.). The study lists 2 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 NCT06293963, which also lists 2 linked publications.
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 24 Apr 2025.