Ultra-processed LabelsUPF-LABELS-NIBNCT07863570
Testing Ultra-processed Warning Labels and Not-Ultra-processed Labels in United States
A study testing NIB: Label exposure in mock-up UPF and Not-UPF products, NIB+UPFWL: Label exposure in mock-up UPF and Not-UPF products and NIB+Not-UPF Black: Label exposure in mock-up UPF and Not-UPF products in people with Ultra-processed Labels, run by Johns Hopkins Bloomberg School of Public Health at 1 site in United States.
Trial summary
This randomized controlled online experiment will test whether adding an ultra-processed food (UPF) warning label or a positive not-ultra-processed (Not-UPF) label, to the FDA's proposed Nutrition Information Box (NIB) changes consumer perceptions of UPFs among U.S. adults. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Ultra-processed Labels
- What is being tested?
- NIB: Label exposure in mock-up UPF and Not-UPF products, NIB+UPFWL: Label exposure in mock-up UPF and Not-UPF products and NIB+Not-UPF Black: Label exposure in mock-up UPF and Not-UPF products
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12,400 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2026to 11 Nov 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 18 years of age or older
- Residing in the United States
- Member of the CloudResearch Panel
Who cannot join
- <18 years of age
- Not residing in the United States
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Johns Hopkins Bloomberg School of Public Health
Baltimore, Maryland, 21205
Daphne A Barquera Guevara, MD, 443-965-6550, dbarque1@jh.edu
About this study
Official title: Testing Adding Ultra-processed Warning Labels and Not-Ultra-Processed Labels in the FDA Nutrition Info Box, a Randomized Online Experiment in Adults in the United States
This randomized controlled online experiment will test whether adding an ultra-processed food (UPF) warning label or a positive not-ultra-processed (Not-UPF) label, to the FDA's proposed Nutrition Information Box (NIB) changes consumer perceptions of UPFs among U.S. adults.
Participants will be randomized to one of four label conditions and will evaluate UPF and Not-UPF products with different nutritional profiles of 3 food categories: yogurts, cereals, and sliced breads. The primary outcome is shelf choice and the secondary outcomes are correct identification of UPF products, perceived healthfulness, perceived usefulness, and perceived message effectiveness.
Read more
This experiment aims to answer the following questions:
Do UPF warning labels and Not-UPF labels shift shelf choice toward Not-UPF products compared to the NIB alone? Is a UPF warning label more effective than a Not-UPF label at shifting shelf choice, decreasing perceived healthfulness, improving correct identification of UPFs, and increasing perceived usefulness and perceived message effectiveness?
Researchers will compare outcomes across the four randomized arms to estimate the independent effect of adding a UPF warning label versus a Not-UPF label beyond nutrient disclosure in the NIB alone.
Read the detailed description
Four-arm parallel randomized controlled trial (RCT) in a national online survey. Participants (n≈12,400; 10,000 adults from a Census-matched panel and 2,400 adults eligible for the Supplemental Nutrition Assistance Program (SNAP) from 12 states) will view identical product images with different labels:
NIB only Control NIB + UPF warning label Black NIB + Not-UPF label Black NIB + Not-UPF label Green
Between-subjects design. Each participant will see one label condition across the whole survey experiment. Outcomes will be measured via Likert scales and binary classification. Randomization implemented in Qualtrics with simple equal allocation.
In the shelf-choice task, participants will view six products per category (3 UPF and 3 Not-UPF) in a simulated online-retail shelf and select the one product the participant would most likely buy. For the UPF-ID task, participants will be assigned to one random category and then indicate whether each of six products (3 UPF and 3 Not-UPF) UPF or not. For perceived healthfulness, participants will be assigned to one random category and then rate for 2 products how good or bad for health it would be to consume every day. After the product tasks, the label will be displayed without a product and participants will answer questions about how useful the participant thinks the label is for making healthy decisions and about the perceived message effectiveness of the label.
The primary comparisons are NIB + UPF warning label versus NIB + Not-UPF label Black, and each of these two conditions versus the NIB only Control. The two Not-UPF label colors will be compared with each other and with the NIB only Control as a secondary comparison.
The investigators hypothesize that the UPF warning label will be more effective than both the Not-UPF label and the NIB alone at shifting shelf choice toward Not-UPF products, improving correct identification of UPF products, lowering perceived healthfulness of UPF products, and increasing perceived usefulness of the label. The investigators further hypothesize that the UPF warning label will produce higher perceived message effectiveness than the Not-UPF label.
- Conditions
- Ultra-processed Labels
- Being tested
- NIB: Label exposure in mock-up UPF and Not-UPF products, NIB+UPFWL: Label exposure in mock-up UPF and Not-UPF products, NIB+Not-UPF Black: Label exposure in mock-up UPF and Not-UPF products, NIB+Not-UPF Green: Label exposure in mock-up UPF and Not-UPF products
- Keywords
- Ultra-processed food, UPF, diet quality, NOVA
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NIB: Label exposure in mock-up UPF and Not-UPF productsBehavioural
This intervention consists of exposure to the FDA Nutrition Information Box (NIB) alone.
Participants view mock-ups of UPF and Not-UPF products in 3 food categories (yogurts, cereals, and sliced breads), each displaying the NIB.
This condition serves as the comparator for estimating how adding a UPF warning label or a Not-UPF label, independent of nutrient content, alters shelf choice, identification of UPF, perceived healthfulness, perceived usefulness, and perceived message effectiveness.
NIB+UPFWL: Label exposure in mock-up UPF and Not-UPF productsBehavioural
This intervention consists of exposure to a UPF warning label embedded within the NIB.
Participants view mock-ups of UPF and Not-UPF products in 3 food categories (yogurts, cereals, and sliced breads), each displaying the NIB+UPFWL.
This intervention tests a processing-based warning label, providing evidence on how a UPF warning label, independent of nutrient content, can alter shelf choice, identification of UPF, perceived healthfulness, perceived usefulness, and perceived message effectiveness.
NIB+Not-UPF Black: Label exposure in mock-up UPF and Not-UPF productsBehavioural
This intervention consists of exposure to a black Not-UPF label embedded NIB.
Participants view mock-ups of UPF and Not-UPF products in 3 food categories (yogurts, cereals, and sliced breads), each displaying the NIB+Not UPF Black.
This intervention tests a positive processing-based label, providing evidence on how a Not-UPF label, independent of nutrient content, can alter shelf choice, identification of UPF, perceived healthfulness, perceived usefulness, and perceived message effectiveness, compared with a UPF warning label and the NIB alone.
NIB+Not-UPF Green: Label exposure in mock-up UPF and Not-UPF productsBehavioural
This intervention consists of exposure to a green Not-UPF label embedded NIB.
Participants view mock-ups of UPF and Not-UPF products in 3 food categories (yogurts, cereals, and sliced breads), each displaying the NIB+Not UPF Green.
This intervention tests a positive processing-based label, providing evidence on how a Not-UPF label, independent of nutrient content, can alter shelf choice, identification of UPF, perceived healthfulness, perceived usefulness, and perceived message effectiveness, compared with a UPF warning label and the NIB alone.
| Study group | Role | What they receive |
|---|---|---|
| Control | Active comparator | Nutrition Info Box (NIB) Only Receives: Behavioral: NIB: Label exposure in mock-up UPF and Not-UPF products |
| NIB + UPFWL | Experimental | Nutrition Info Box (NIB) + Ultra-Processed Warning Label Receives: Behavioral: NIB+UPFWL: Label exposure in mock-up UPF and Not-UPF products |
| NIB + Not-UPF Black | Experimental | Nutrition Info Box (NIB) + Not Ultra-Processed Label (Black) Receives: Behavioral: NIB+Not-UPF Black: Label exposure in mock-up UPF and Not-UPF products |
| NIB + Not-UPF Green | Experimental | Nutrition Info Box (NIB) + Not Ultra-Processed Label (Green) Receives: Behavioral: NIB+Not-UPF Green: Label exposure in mock-up UPF and Not-UPF products |
What is being measured
The primary outcome is the main question the study is designed to answer.
Shelf Choice (UPF or Not UPF product)
Binary variable (1 = selects a Not-UPF product; 0 = selects a UPF product). In each of three food categories (yogurt, cereal, and sliced bread), participants view six products (3 UPF and 3 Not-UPF) in a simulated online-retail shelf and select the one product the participant would most like to buy, giving three choices per participant. The three choices are analyzed together as repeated measures, accounting for food category, and reported as the percentage of choices that are Not-UPF products. Higher values indicate a greater tendency to choose Not-UPF products.
Measured: Immediately after label exposure
Secondary outcomes (4)
Correct Identification of UPF
Binary variable (1 = correct; 0 = incorrect). In one randomly assigned food category, participants indicate whether the participant thinks each of six products (3 UPF and 3 Not-UPF) is UPF. Each product is coded as correct or incorrect, with "Not sure" coded as incorrect. Higher values indicate greater identification accuracy.
Measured: Immediately after label exposure
Perceived Healthfulness Rating
Participants rate two products (one UPF, one not UPF) from the same randomly assigned food category (yogurt, cereal, or sliced bread) on a 5-point Likert scale from 1 = "Very bad" to 5 = "Very good" indicating how good or bad for health, the participant believes it would be to consume the product every day. Higher scores indicate greater perceived healthfulness.
Measured: Immediately after label exposure
Perceived Usefulness Rating
Participants rate the assigned label on a 5-point Likert scale from 1 = "Not at all confident" to 5 = "Extremely confident" indicating how confident the participant is that the label could be used to help make healthy decisions. Higher scores indicate greater perceived usefulness of the label.
Measured: Immediately after label exposure
Perceived Message Effectiveness Rating
Participants complete a 3-item perceived message effectiveness scale rated on a 5-point Likert scale from 1 = "Not at all" to 5 = "A great deal" indicating how much the label discourages the participant from wanting to consume UPFs, makes the participant concerned about the health effects of consuming UPFs, and makes consuming UPFs seem unpleasant. Items are averaged into a composite PME score. Higher scores indicate greater perceived message effectiveness.
Measured: Immediately after label exposure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Oct 2026
- Study startOct 2026 (estimated)
- Primary completion11 Nov 2026 (estimated)
- Study completion11 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ultra-processed LabelsStudies of the same condition, open and under way.
- 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
- Model description
- Participants will view UPF and Not-UPF products with different nutritional profiles across 3 food categories: yogurt, cereal, and sliced bread presented in random order. Participants will be randomized to view the products with one of four labeling schemes applied: (1) NIB only Control, (2) NIB + UPF warning label Black, (3) NIB + Not-UPF label Black, (4) NIB + Not-UPF label Green. Participants will first complete a shelf-choice task, selecting the one product the participant would most likely buy out of six products (3 UPF and 3 Not-UPF) in each category. In one randomly assigned category, participants will then answer survey questions to assess correct identification of 6 products and the perceived healthfulness of 2 products. Then, participants will view the assigned label again and answer additional questions about how useful the label is and the perceived message effectiveness of the label.
- Masking
- None (open label)
- Enrolment
- 12,400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins Bloomberg School of Public Health
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Julia A Wolfson, PhD, Principal investigator, Johns Hopkins Bloomberg School of Public Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07863570
- Sponsor's protocol ID
- IRB00034378-MOD
- Other IDs
- MOD00007920
- Acronym
- UPF-LABELS-NIB
- Status last verified
- Oct 2026
- First submitted
- 2 Oct 2026
- Last updated
- 26 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Testing Adding Ultra-processed Warning Labels and Not-Ultra-Processed Labels in the FDA Nutrition Info Box, a Randomized Online Experiment in Adults in the United States
- ClinicalTrials.gov ID
- NCT07863570
- Acronym / sponsor ID
- UPF-LABELS-NIB / IRB00034378-MOD
- Conditions
- Ultra-processed Labels
- Keywords
- Ultra-processed food, UPF, diet quality, NOVA
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 12,400 participants (estimated)
- Lead sponsor
- Johns Hopkins Bloomberg School of Public HealthUniversity, hospital or other
- Study start
- Oct 2026 (estimated)
- Primary completion
- 11 Nov 2026 (estimated)
- Study completion
- 11 Nov 2026 (estimated)
- First posted
- 7 Oct 2026 (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 randomized controlled online experiment will test whether adding an ultra-processed food (UPF) warning label or a positive not-ultra-processed (Not-UPF) label, to the FDA's proposed Nutrition Information Box (NIB) changes consumer perceptions of UPFs among U.S. adults.
Participants will be randomized to one of four label conditions and will evaluate UPF and Not-UPF products with different nutritional profiles of 3 food categories: yogurts, cereals, and sliced breads. The primary outcome is shelf choice and the secondary outcomes are correct identification of UPF products, perceived healthfulness, perceived usefulness, and perceived message effectiveness.
This experiment aims to answer the following questions:
Do UPF warning labels and Not-UPF labels shift shelf choice toward Not-UPF products compared to the NIB alone? Is a UPF warning label more effective than a Not-UPF label at shifting shelf choice, decreasing perceived healthfulness, improving correct identification of UPFs, and increasing perceived usefulness and perceived message effectiveness?
Researchers will compare outcomes across the four randomized arms to estimate the independent effect of adding a UPF warning label versus a Not-UPF label beyond nutrient disclosure in the NIB alone.
Detailed description
Four-arm parallel randomized controlled trial (RCT) in a national online survey. Participants (n≈12,400; 10,000 adults from a Census-matched panel and 2,400 adults eligible for the Supplemental Nutrition Assistance Program (SNAP) from 12 states) will view identical product images with different labels:
NIB only Control NIB + UPF warning label Black NIB + Not-UPF label Black NIB + Not-UPF label Green
Between-subjects design. Each participant will see one label condition across the whole survey experiment. Outcomes will be measured via Likert scales and binary classification. Randomization implemented in Qualtrics with simple equal allocation.
In the shelf-choice task, participants will view six products per category (3 UPF and 3 Not-UPF) in a simulated online-retail shelf and select the one product the participant would most likely buy. For the UPF-ID task, participants will be assigned to one random category and then indicate whether each of six products (3 UPF and 3 Not-UPF) UPF or not. For perceived healthfulness, participants will be assigned to one random category and then rate for 2 products how good or bad for health it would be to consume every day. After the product tasks, the label will be displayed without a product and participants will answer questions about how useful the participant thinks the label is for making healthy decisions and about the perceived message effectiveness of the label.
The primary comparisons are NIB + UPF warning label versus NIB + Not-UPF label Black, and each of these two conditions versus the NIB only Control. The two Not-UPF label colors will be compared with each other and with the NIB only Control as a secondary comparison.
The investigators hypothesize that the UPF warning label will be more effective than both the Not-UPF label and the NIB alone at shifting shelf choice toward Not-UPF products, improving correct identification of UPF products, lowering perceived healthfulness of UPF products, and increasing perceived usefulness of the label. The investigators further hypothesize that the UPF warning label will produce higher perceived message effectiveness than the Not-UPF label.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- Participants will view UPF and Not-UPF products with different nutritional profiles across 3 food categories: yogurt, cereal, and sliced bread presented in random order. Participants will be randomized to view the products with one of four labeling schemes applied: (1) NIB only Control, (2) NIB + UPF warning label Black, (3) NIB + Not-UPF label Black, (4) NIB + Not-UPF label Green. Participants will first complete a shelf-choice task, selecting the one product the participant would most likely buy out of six products (3 UPF and 3 Not-UPF) in each category. In one randomly assigned category, participants will then answer survey questions to assess correct identification of 6 products and the perceived healthfulness of 2 products. Then, participants will view the assigned label again and answer additional questions about how useful the label is and the perceived message effectiveness of the label.
| Arm | Type | Receives |
|---|---|---|
| Control | Active comparator | Behavioral: NIB: Label exposure in mock-up UPF and Not-UPF productsNutrition Info Box (NIB) Only |
| NIB + UPFWL | Experimental | Behavioral: NIB+UPFWL: Label exposure in mock-up UPF and Not-UPF productsNutrition Info Box (NIB) + Ultra-Processed Warning Label |
| NIB + Not-UPF Black | Experimental | Behavioral: NIB+Not-UPF Black: Label exposure in mock-up UPF and Not-UPF productsNutrition Info Box (NIB) + Not Ultra-Processed Label (Black) |
| NIB + Not-UPF Green | Experimental | Behavioral: NIB+Not-UPF Green: Label exposure in mock-up UPF and Not-UPF productsNutrition Info Box (NIB) + Not Ultra-Processed Label (Green) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 18 years of age or older
- Residing in the United States
- Member of the CloudResearch Panel
Key exclusion criteria (2 listed)
- <18 years of age
- 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 |
|---|---|---|
| NIB: Label exposure in mock-up UPF and Not-UPF productsThis intervention consists of exposure to the FDA Nutrition Information Box (NIB) alone. Participants view mock-ups of UPF and Not-UPF products in 3 food categories (yogurts, cereals, and sliced breads), each displaying the NIB. This condition serves as the comparator for estimating how adding a UPF warning label or a Not-UPF label, independent of nutrient content, alters shelf choice, identification of UPF, perceived healthfulness, perceived usefulness, and perceived message effectiveness. | Behavioural | Control |
| NIB+UPFWL: Label exposure in mock-up UPF and Not-UPF productsThis intervention consists of exposure to a UPF warning label embedded within the NIB. Participants view mock-ups of UPF and Not-UPF products in 3 food categories (yogurts, cereals, and sliced breads), each displaying the NIB+UPFWL. This intervention tests a processing-based warning label, providing evidence on how a UPF warning label, independent of nutrient content, can alter shelf choice, identification of UPF, perceived healthfulness, perceived usefulness, and perceived message effectiveness. | Behavioural | NIB + UPFWL |
| NIB+Not-UPF Black: Label exposure in mock-up UPF and Not-UPF productsThis intervention consists of exposure to a black Not-UPF label embedded NIB. Participants view mock-ups of UPF and Not-UPF products in 3 food categories (yogurts, cereals, and sliced breads), each displaying the NIB+Not UPF Black. This intervention tests a positive processing-based label, providing evidence on how a Not-UPF label, independent of nutrient content, can alter shelf choice, identification of UPF, perceived healthfulness, perceived usefulness, and perceived message effectiveness, compared with a UPF warning label and the NIB alone. | Behavioural | NIB + Not-UPF Black |
| NIB+Not-UPF Green: Label exposure in mock-up UPF and Not-UPF productsThis intervention consists of exposure to a green Not-UPF label embedded NIB. Participants view mock-ups of UPF and Not-UPF products in 3 food categories (yogurts, cereals, and sliced breads), each displaying the NIB+Not UPF Green. This intervention tests a positive processing-based label, providing evidence on how a Not-UPF label, independent of nutrient content, can alter shelf choice, identification of UPF, perceived healthfulness, perceived usefulness, and perceived message effectiveness, compared with a UPF warning label and the NIB alone. | Behavioural | NIB + Not-UPF Green |
Primary outcome
Shelf Choice (UPF or Not UPF product)
Time frame: Immediately after label exposure
Binary variable (1 = selects a Not-UPF product; 0 = selects a UPF product). In each of three food categories (yogurt, cereal, and sliced bread), participants view six products (3 UPF and 3 Not-UPF) in a simulated online-retail shelf and select the one product the participant would most like to buy, giving three choices per participant. The three choices are analyzed together as repeated measures, accounting for food category, and reported as the percentage of choices that are Not-UPF products. Higher values indicate a greater tendency to choose Not-UPF products.
4 secondary outcomes
Correct Identification of UPF
Time frame: Immediately after label exposure
Perceived Healthfulness Rating
Time frame: Immediately after label exposure
Perceived Usefulness Rating
Time frame: Immediately after label exposure
Perceived Message Effectiveness Rating
Time frame: Immediately after label exposure
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2026.
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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.
Julia A Wolfson, PhD principal investigator
Johns Hopkins Bloomberg School of Public Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing NIB: Label exposure in mock-up UPF and Not-UPF products, NIB+UPFWL: Label exposure in mock-up UPF and Not-UPF products and NIB+Not-UPF Black: Label exposure in mock-up UPF and Not-UPF products in people with Ultra-processed Labels, run by Johns Hopkins Bloomberg School of Public Health 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: opening soon, as of the sponsor's last update on 26 Oct 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Daphne A Barquera Guevara, MD (4439656550, dbarque1@jh.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Shelf Choice (UPF or Not UPF product) (time frame: Immediately after label exposure). 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 26 Oct 2026.