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OpenTrials
Completed

NCT Number: NCT07533877

Testing Ultra-processed Warning Labels in 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.

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.

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Key information

Conditions

Diet Behavior Consumer Behavior Nutrition Labeling

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Johns Hopkins Bloomberg School of Public Health

Baltimore, Maryland, 21205, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Label exposure in mock-up UPF products

Behavioral

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. Correct Identification of UPF

    Time frame: Immediately after label exposure

    Binary variable (1 = correctly identifies product as ultra-processed; 0 = incorrect). Participants indicate whether the participant thinks the product is ultra-processed

  2. Perceived Healthfulness

    Time frame: Immediately after label exposure

    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.

  3. Perceived Usefulness

    Time frame: Immediately after label exposure

    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.

Sponsors and collaborators

Lead sponsor

Johns Hopkins Bloomberg School of Public Health

Other

Registry information

Official study title

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

Acronym: UPFWL-NIB

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Apr 16, 2026
Registry last updated
Jun 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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