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Testing Ultra-processed Warning Labels in United States

Testing Adding Ultra-processed Warning Labels in the FDA Nutrition Info Box, a Randomized Online Experiment in Adults in the United States

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07533877
Acronym
UPFWL-NIB
Enrollment
7000
Registered
2026-04-16
Start date
2026-04-13
Completion date
2026-05-04
Last updated
2026-06-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Consumer Behavior, Diet, Nutrition Labeling

Keywords

Diet, Nutrition Labeling, Ultra-processed, Consumer Behavior

Brief 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. 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.

Interventions

BEHAVIORALLabel exposure in mock-up UPF products

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.

Sponsors

Johns Hopkins Bloomberg School of Public Health
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Intervention 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.

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

* 18 years of age or older * Member of the Verasight Panel * Residing in the United States

Exclusion criteria

* \<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

Design outcomes

Primary

MeasureTime frameDescription
Purchase IntentImmediately after label exposureLikelihood 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.

Secondary

MeasureTime frameDescription
Correct Identification of UPFImmediately after label exposureBinary variable (1 = correctly identifies product as ultra-processed; 0 = incorrect). Participants indicate whether the participant thinks the product is ultra-processed
Perceived HealthfulnessImmediately after label exposureParticipants 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.
Perceived UsefulnessImmediately after label exposureParticipants 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.

Countries

United States

Contacts

PRINCIPAL_INVESTIGATORJulia Wolfson, PhD

Johns Hopkins University

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jun 13, 2026