An interventional study of Health Warning Label and Identity Warning Label in Health Behavior and Diet, Healthy, sponsored by University of North Carolina, Chapel Hill. Completed at 1 site in United States. Open to participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-10-15.
Sponsored by University of North Carolina, Chapel Hill · Not applicable, Interventional, and Prevention
Purpose: The overall purpose of this study is to identify the impacts of an ultra-processed (UPF) health warning label and UPF identify warning label compared to a control label (i.e., a barcode).
Participants: \~4,000 US Latino adults of parental age (18-55 years), approximately 50% of whom will have limited English proficiency, recruited from a Latino-focused panel company.
Procedures: Participants will be randomly assigned to view food products with one of three label types: health warning labels, identity labels, or barcode control labels. Participants will be asked a series of questions about the products and the label they were assigned.
On the study platform (Qualtrics), participants will be randomly assigned to 1 of 3 arms with equal probability: a UPF health warning label, a UPF identity label, or a barcode control label. Participants will view four products (a fruit-flavored drink, pretzels, a yogurt, and a breakfast cereal) displayed in random order, each with a label displayed on the front of package according to the participants' study arm. Participants will complete a 13-item online survey to assess each product as to a) whether the product is ultra-processed; b) perceptions of healthfulness; c) intentions to purchase the product.
University of North Carolina, Chapel Hill is the lead sponsor of 1,340 studies on the registry; 133 are open to participants now.
Of its 155 completed or terminated interventional studies of FDA-regulated products, 136 (88%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Participants will view four products (a fruit-flavored drink, pretzels, a yogurt, and a breakfast cereal) each with a health warning label displayed on the front of package.
Behavioral: Health Warning Label
Participants will view four products (a fruit-flavored drink, pretzels, a yogurt, and a breakfast cereal) each with an identity warning label displayed on the front of package.
Behavioral: Identity Warning Label
Participants will view four products (a fruit-flavored drink, pretzels, a yogurt, and a breakfast cereal) each with a barcode control label displayed on the front of package.
Other: Barcode Label
Message displayed on warning label is: "WARNING: Consuming ultra-processed food and drinks can cause weight gain, which increases the risk of obesity and type 2 diabetes."
Message displayed on warning label is: "WARNING: Ultra-processed food".
Barcode is displayed.
Identification of a product as ultra-processed
Correct identification of a product as ultra-processed. Measured with the question, "Do you think this product is ultra-processed?" Response options are Yes, No, and I'm not sure.
Time frame: Immediately after exposure to intervention, assessed during 1-time online study visit.
Perceived product healthfulness of ultra-processed products
Measured with the question, "How good or bad for your health would it be to consume this product every day?" Likert responses are on a 1 to 5 scale, from "Very bad" (coded as 1) to "Very good" (coded as 5), with higher scores representing a higher perceived healthfulness.
Time frame: Immediately after exposure to intervention, assessed during 1-time online study visit.
Intentions to purchase ultra-processed products
Measured with the question, "How likely would you be to purchase this product in the next week, if it were available?" Likert responses are on a 1 to 5 scale, from "Not at all likely" (coded as 1) to "Extremely likely" (coded as 5), with higher scores representing a higher intention to purchase ultra-processed products.
Time frame: Immediately after exposure to intervention, assessed during 1-time online study visit.
Perceived message effectiveness
Measured with the question, "How much does this message discourage you from wanting to consume an ultra-processed food or drink?" Likert responses are on a 1 to 5 scale, from "Not at all" (coded as 1) to "Very much" (coded as 5), with higher scores representing a higher perceived message effectiveness.
Time frame: Immediately after exposure to intervention, assessed during 1-time online study visit.
Documents are hosted by the registry — open the source record to download them.
Plan to share: Yes — A deidentified dataset and the corresponding survey codebook will be shared beginning 9 months and continuing for 36 months after publication provided the investigator who proposes to use the data has approval from an Institutional Review Board (IRB), Independent Ethics Committee (IEC), or Research Ethics Board (REB), as applicable, and executes a data use/sharing agreement with UNC. The study protocol, statistical analysis plan, and informed consent form will be published alongside as supplementary material.
Supporting information: Study protocol, Sap, Icf
This study is completed, as verified in Oct 2024. You cannot join it, but the record below documents what was studied.
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University of North Carolina, Chapel Hill