DietUPFWL-NIBNCT07533877
Testing Ultra-processed Warning Labels in United States
A study testing Label exposure in mock-up UPF products in people with Diet and Consumer Behavior, 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 to the FDA's proposed Nutrition Information Box (NIB) changes consumer perceptions of UPFs among a nationally representative sample of 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
- Diet, Consumer Behavior, Nutrition Labeling
- What is being tested?
- Label exposure in mock-up UPF products
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7,000 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Apr 2026to 4 May 2026
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 18 years of age or older
- Member of the Verasight Panel
- Residing in the United States
Who cannot join
- <18 years of age
- Not residing in the United States
- Completed the survey in less than one-third of the median completion duration of all participants
- Respondents with high refusal rates (skipped or refused more than 50% of questions)
- Respondents who 'straight-line' all question grids with 6 or more items, where responses are not internally consistent
Trial locations and contacts
1 site in 1 country.
United States1 site
Johns Hopkins Bloomberg School of Public Health
Baltimore, Maryland, 21205
About this study
Official title: Testing Adding Ultra-processed Warning 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 to the FDA's proposed Nutrition Information Box (NIB) changes consumer perceptions of UPFs among a nationally representative sample of U.S. adults.
Participants will be randomized to one of four label conditions and will evaluate four UPF yogurt products with different nutritional profiles on the NIB. The primary outcome is purchase intent and the secondary outcomes are perceived healthfulness, perceived usefulness and correct identification of UPF products.
Read more
This experiment aims to answer the following questions:
Do UPF warning labels reduce purchase intentions compared to the NIB alone? Do UPF warning labels reduce perceived healthfulness compared to the NIB alone? Do UPF warning labels help more consumers correctly identify products as ultra-processed compared to the NIB alone? Do different UPF warning label color designs differ in effectiveness at reducing purchase intentions, lowering perceived healthfulness, and improving correct identification of UPFs?
Researchers will compare outcomes across the four randomized arms to estimate the independent effect of adding UPF warnings beyond nutrient disclosure in the NIB alone.
Read the detailed description
Four-arm parallel randomized controlled trial (RCT) in a nationally representative online survey. Participants (n≈7,000) will view identical product images with different UPFWL: NIB only Control, NIB + UPF label Yellow, NIB + UPF label Red, NIB + UPF label Black.
Between-subjects design. Each participant will see one label condition across four products (presented in a random order). Outcomes will be measured via Likert scales and binary classification. Randomization implemented in Qualtrics with simple equal allocation. After viewing each product participants will answer questions about the intention to purchase the product, how healthy the participant thinks the product is, and whether or not the product is a UPF. After presentation of the 4 products, the label will be displayed again and participants will answer questions about how useful the participant thinks the label is for making decisions about how well a food fits into a healthy diet.
The investigators hypothesize that all UPF warning labels (UPFWL) will be more effective than the Nutrition Information Box (NIB) alone, with the red UPF warning label being the most effective, followed by the yellow label, and the black label being the least effective at reducing purchase intention, lowering perceived healthfulness, increasing perceived usefulness, and improving correct identification of ultra-processed products.
- Conditions
- Diet, Consumer Behavior, Nutrition Labeling
- Being tested
- Label exposure in mock-up UPF products
- Keywords
- Diet, Nutrition Labeling, Ultra-processed, Consumer Behavior
- Medical subject headings
- Consumer Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Label exposure in mock-up UPF productsBehavioural
This intervention consists of exposure to ultra-processed warning label (UPFWL) conditions embedded within the FDA Nutrition Information Box (NIB). Participants view mock-ups of ultra-processed yogurt products displaying either the NIB alone or the NIB combined with a UPFWL (yellow, red, or black). This intervention experimentally isolates the incremental effect of adding a processing-based warning across products with varying nutritional profiles, providing evidence on how UPFWL, independent of nutrient content, can alter purchase intent, identification of UPFs and perceived healthfulness.
| Study group | Role | What they receive |
|---|---|---|
| Control | Active comparator | NIB only Receives: Behavioral: Label exposure in mock-up UPF products |
| NIB + UPFWL 1 | Experimental | NIB + UPF Warning Label Yellow Receives: Behavioral: Label exposure in mock-up UPF products |
| NIB + UPFWL 2 | Experimental | NIB + UPF Warning Label Red Receives: Behavioral: Label exposure in mock-up UPF products |
| NIB + UPFWL 3 | Experimental | NIB + UPF Warning Label Black Receives: Behavioral: Label exposure in mock-up UPF products |
What is being measured
The primary outcome is the main question the study is designed to answer.
Purchase Intent
Likelihood of purchasing each product measured on a 5-point Likert scale from 1 = "Very unlikely" to 5 = "Very likely" indicating how likely the participant would be to buy the product in the next week if it were available in a store. Higher scores indicate greater purchase intent.
Measured: Immediately after label exposure
Secondary outcomes (3)
Correct Identification of UPF
Binary variable (1 = correctly identifies product as ultra-processed; 0 = incorrect). Participants indicate whether the participant thinks the product is ultra-processed
Measured: Immediately after label exposure
Perceived Healthfulness
Participants rate each product on a 5-point Likert scale from 1 = "Very unhealthy" to 5 = "Very healthy" 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
Participants rate each 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 decisions about how well the food fits into a healthy diet. Higher scores indicate greater perceived usefulness of the label.
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 posted16 Apr 2026
- Study start13 Apr 2026
- Primary completion4 May 2026
- Study completion4 May 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DietStudies 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 four UPF yogurt products of different nutritional profiles (presented in random order). Participants will be randomized to view the yogurt products with one of four labeling schemes applied: (1) NIB only Control, (2) NIB + UPF label Yellow, (3) NIB + UPF label Red, (4) NIB + UPF label Black. After viewing each product, participants will answer survey questions to assess the intention to purchase the product and the perceived healthfulness of the product, and correct identification of UPF products. Then, the participant will view the assigned label again and answer an additional question about how useful the label is.
- Masking
- None (open label)
- Enrolment
- 7,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins Bloomberg School of Public Health
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Julia Wolfson, PhD, Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07533877
- Sponsor's protocol ID
- IRB00035394-B
- Acronym
- UPFWL-NIB
- Status last verified
- Jun 2026
- First submitted
- 10 Apr 2026
- Last updated
- 12 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Testing Adding Ultra-processed Warning Labels in the FDA Nutrition Info Box, a Randomized Online Experiment in Adults in the United States
- ClinicalTrials.gov ID
- NCT07533877
- Acronym / sponsor ID
- UPFWL-NIB / IRB00035394-B
- Conditions
- Diet, Consumer Behavior, Nutrition Labeling
- Keywords
- Diet, Nutrition Labeling, Ultra-processed, Consumer Behavior
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 7,000 participants (actual)
- Lead sponsor
- Johns Hopkins Bloomberg School of Public HealthUniversity, hospital or other
- Study start
- 13 Apr 2026 (actual)
- Primary completion
- 4 May 2026 (actual)
- Study completion
- 4 May 2026 (actual)
- First posted
- 16 Apr 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 to the FDA's proposed Nutrition Information Box (NIB) changes consumer perceptions of UPFs among a nationally representative sample of U.S. adults.
Participants will be randomized to one of four label conditions and will evaluate four UPF yogurt products with different nutritional profiles on the NIB. The primary outcome is purchase intent and the secondary outcomes are perceived healthfulness, perceived usefulness and correct identification of UPF products.
This experiment aims to answer the following questions:
Do UPF warning labels reduce purchase intentions compared to the NIB alone? Do UPF warning labels reduce perceived healthfulness compared to the NIB alone? Do UPF warning labels help more consumers correctly identify products as ultra-processed compared to the NIB alone? Do different UPF warning label color designs differ in effectiveness at reducing purchase intentions, lowering perceived healthfulness, and improving correct identification of UPFs?
Researchers will compare outcomes across the four randomized arms to estimate the independent effect of adding UPF warnings beyond nutrient disclosure in the NIB alone.
Detailed description
Four-arm parallel randomized controlled trial (RCT) in a nationally representative online survey. Participants (n≈7,000) will view identical product images with different UPFWL: NIB only Control, NIB + UPF label Yellow, NIB + UPF label Red, NIB + UPF label Black.
Between-subjects design. Each participant will see one label condition across four products (presented in a random order). Outcomes will be measured via Likert scales and binary classification. Randomization implemented in Qualtrics with simple equal allocation. After viewing each product participants will answer questions about the intention to purchase the product, how healthy the participant thinks the product is, and whether or not the product is a UPF. After presentation of the 4 products, the label will be displayed again and participants will answer questions about how useful the participant thinks the label is for making decisions about how well a food fits into a healthy diet.
The investigators hypothesize that all UPF warning labels (UPFWL) will be more effective than the Nutrition Information Box (NIB) alone, with the red UPF warning label being the most effective, followed by the yellow label, and the black label being the least effective at reducing purchase intention, lowering perceived healthfulness, increasing perceived usefulness, and improving correct identification of ultra-processed products.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- Participants will view four UPF yogurt products of different nutritional profiles (presented in random order). Participants will be randomized to view the yogurt products with one of four labeling schemes applied: (1) NIB only Control, (2) NIB + UPF label Yellow, (3) NIB + UPF label Red, (4) NIB + UPF label Black. After viewing each product, participants will answer survey questions to assess the intention to purchase the product and the perceived healthfulness of the product, and correct identification of UPF products. Then, the participant will view the assigned label again and answer an additional question about how useful the label is.
| Arm | Type | Receives |
|---|---|---|
| Control | Active comparator | Behavioral: Label exposure in mock-up UPF productsNIB only |
| NIB + UPFWL 1 | Experimental | Behavioral: Label exposure in mock-up UPF productsNIB + UPF Warning Label Yellow |
| NIB + UPFWL 2 | Experimental | Behavioral: Label exposure in mock-up UPF productsNIB + UPF Warning Label Red |
| NIB + UPFWL 3 | Experimental | Behavioral: Label exposure in mock-up UPF productsNIB + UPF Warning Label Black |
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
- Member of the Verasight Panel
- Residing in the United States
Key exclusion criteria (5 listed)
- <18 years of age
- Not residing in the United States
- Completed the survey in less than one-third of the median completion duration of all participants
- Respondents with high refusal rates (skipped or refused more than 50% of questions)
- Respondents who 'straight-line' all question grids with 6 or more items, where responses are not internally consistent
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 |
|---|---|---|
| Label exposure in mock-up UPF productsThis intervention consists of exposure to ultra-processed warning label (UPFWL) conditions embedded within the FDA Nutrition Information Box (NIB). Participants view mock-ups of ultra-processed yogurt products displaying either the NIB alone or the NIB combined with a UPFWL (yellow, red, or black). This intervention experimentally isolates the incremental effect of adding a processing-based warning across products with varying nutritional profiles, providing evidence on how UPFWL, independent of nutrient content, can alter purchase intent, identification of UPFs and perceived healthfulness. | Behavioural | Control, NIB + UPFWL 1, NIB + UPFWL 2, NIB + UPFWL 3 |
Primary outcome
Purchase Intent
Time frame: Immediately after label exposure
Likelihood of purchasing each product measured on a 5-point Likert scale from 1 = "Very unlikely" to 5 = "Very likely" indicating how likely the participant would be to buy the product in the next week if it were available in a store. Higher scores indicate greater purchase intent.
3 secondary outcomes
Correct Identification of UPF
Time frame: Immediately after label exposure
Perceived Healthfulness
Time frame: Immediately after label exposure
Perceived Usefulness
Time frame: Immediately after label 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 12 Jun 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. This study is not recruiting at the moment.
Julia Wolfson, PhD principal investigator
Johns Hopkins University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Label exposure in mock-up UPF products in people with Diet and Consumer Behavior, 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 5 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 12 Jun 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?
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?
Purchase Intent (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 12 Jun 2026.