An interventional study of NIB: Label exposure in mock-up UPF and Not-UPF products and NIB+UPFWL: Label exposure in mock-up UPF and Not-UPF products in Ultra-Processed Labels, sponsored by Johns Hopkins Bloomberg School of Public Health. Not yet recruiting at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-10-07.
Sponsored by Johns Hopkins Bloomberg School of Public Health · Not applicable, Interventional, and Prevention
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.
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.
Johns Hopkins Bloomberg School of Public Health is the lead sponsor of 364 studies on the registry; 41 are open to participants now.
Of its 5 completed or terminated interventional studies of FDA-regulated products, 3 (60%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Nutrition Info Box (NIB) Only
Behavioral: NIB: Label exposure in mock-up UPF and Not-UPF products
Nutrition Info Box (NIB) + Ultra-Processed Warning Label
Behavioral: NIB+UPFWL: Label exposure in mock-up UPF and Not-UPF products
Nutrition Info Box (NIB) + Not Ultra-Processed Label (Black)
Behavioral: NIB+Not-UPF Black: Label exposure in mock-up UPF and Not-UPF products
Nutrition Info Box (NIB) + Not Ultra-Processed Label (Green)
Behavioral: NIB+Not-UPF Green: Label exposure in mock-up UPF and Not-UPF products
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.
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.
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.
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.
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.
Time frame: Immediately after label exposure
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Immediately after label exposure
Label Noticing
Binary variable (1 = Yes; 0 = No). After the product tasks, participants are asked to "think back to when they were choosing the products they would most likely buy" and report whether the participant saw any labels on the foods when choosing what to buy (Yes/No). Higher values indicate greater label noticing.
Time frame: Immediately after label exposure
Label Recall
Binary variable (1 = correctly recalls the assigned label; 0 = does not correctly recall the assigned label). All participants answer "What did the label(s) you saw tell you about?", selecting all that apply from a list presented in random order: UPF, Not UPF, nutrient content (sodium, sugar, saturated fat), calories, calcium, fiber, organic, gluten free, or none of these options. Correct recall is defined as selecting "Nutrient content" in the Control arm; selecting both "Nutrient content" and "UPF" in the UPF warning label arm; and selecting both "Nutrient content" and "Not UPF" in the two Not-UPF label arms. Higher values indicate greater label recall.
Time frame: Immediately after label exposure
Label Use
Binary variable (1 = Yes; 0 = No). All participants report whether the participant used the label(s) seen on the products when deciding what to buy (Yes/No). Higher values indicate greater label use.
Time frame: Immediately after label exposure
Perceived Helpfulness Rating
Participants rate whether the information on the label(s) made the participant feel less or more in control of making eating decisions, on a 3-point scale: 1 = "Less in control of making eating decisions," 2 = "Neither more nor less in control of making eating decisions," 3 = "More in control of making eating decisions." Higher scores indicate greater perceived helpfulness of the label.
Time frame: Immediately after label exposure
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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Johns Hopkins Bloomberg School of Public Health