An interventional study of Alcohol Cancer Warning Labels in Alcohol, sponsored by University of Miami. Not yet recruiting at 1 site in United States. Open to participants aged 21 Years and older. Per ClinicalTrials.gov, last updated 2026-10-01.
Sponsored by University of Miami · Not applicable, Interventional, and Basic science
This pilot study will evaluate communication strategies that may improve public understanding of alcohol-related cancer risks and influence behavioral intentions. The study will compare graphic alcohol cancer warning labels with the current U.S. Surgeon General text-only warning label across two stages. The first stage is an in-person, lab-based eye-tracking experiment that will examine differences in visual attention, communication outcomes, harm perception, and behavioral intentions following exposure to graphic versus text-only warning labels. The second stage is a discrete choice experiment that will examine how warning label type, warning label size, and alcohol type (beer, wine, or liquor) influence participants' intentions to reduce or stop alcohol consumption and purchase alcohol. The study will recruit 50 adults aged 21 years or older who report regular alcohol consumption.
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This study's planned enrollment of 50 is close to the median of 50 across 7,253 interventional studies indexed under Neoplasms.
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Exclusion Criteria:
Participants will complete a 2-stage behavioral experiment during a single study visit. Stage 1 Eye-Tracking Experiment: Participants will complete an eye-tracking experiment during which they will view six alcohol warning-label stimuli presented one at a time in a randomized, counterbalanced order. The stimuli include graphic and text-only warning labels displayed on beer, wine, and liquor containers. Stage 2 Discrete Choice Experiment: Following completion of the eye-tracking experiment, participants will complete a discrete choice experiment consisting of 18 randomly presented choice sets that vary by warning label type, warning label size, and alcohol type. Participants' responses will be used to assess preferences and behavioral reactions to different alcohol warning-label characteristics.
Behavioral: Alcohol Cancer Warning Labels
Participants will be exposed to alcohol-cancer warning labels during two sequential study states. Stage 1 consists of Eye-Tracking Experiment in which participants will be exposed to six alcohol warning-label stimuli, including graphic alcohol cancer warning labels and Surgeon General text-only warning labels displayed on beer, wine, and liquor containers. Each participant will view all six warning-label stimuli for 15 seconds each in a randomized, counterbalanced order while visual attention is measured using eye-tracking technology. Stage 2 consist of the Discrete Choice Experiment in which participants will choose between 18 randomly presented choice sets. Choice sets will vary by warning label type, warning label size, and alcohol type (beer, wine, or liquor). Participants' responses will be used to assess preferences and behavioral reactions to different alcohol warning-label characteristics.
Visual Attention Metrics
Visual attention to predefined areas of interest (AOIs) containing graphic and text-only alcohol warning labels on alcohol beverage container stimuli will be assessed using eye-tracking. Outcome measures include: (1) time to first fixation (milliseconds), defined as the elapsed time from stimulus presentation to the participant's first fixation on an AOI; (2) visit count, defined as the number of visits to an AOI; and (3) dwell time (milliseconds), defined as the cumulative duration of fixations within an AOI. Higher visit counts and dwell times indicate greater visual attention to the warning label.
Time frame: During Stage 1 of the single study visit, approximately 35-45 minutes
Intention to Reduce Alcohol Consumption in the Next 30 Days
Participants will select between warning label alternatives that vary by warning label type, warning label size, and alcohol type. The outcome will be measured as the frequency or probability of selecting warning label alternatives perceived as most likely to increase intentions to reduce alcohol consumption within the next 30 days.
Time frame: During Stage 2 of the single study visit, approximately 10-20 minutes
Emotional Reactions to Alcohol Warning Labels
Emotional reactions following exposure to the warning labels will include believability, avoidance, cognitive elaboration, and negative affective responses. Believability will be assessed on a scale from 1 (strongly disagree) to 5 (strongly agree). Avoidance will be assessed as yes/no. Cognitive elaboration will be assessed using three items on a scale from 1 (not at all) to 5 (very much), with higher scores indicating greater cognitive processing of the warning label message.. Negative affect will be assessed using five items on a scale from 1 (not at all) to 5 (very much),with higher scores indicating greater negative emotional response.
Time frame: After each warning-label exposure during Stage 1 of the single study visit, approximately 35-45 minutes
Change in Harm Perception
Change in harm perception will be assessed with one item asking how worried the participant is that alcohol drinking puts them at risk of cancer in the future, on a scale from 1 (not worried) to 5 (very worried).
Time frame: "Baseline" or "Day 1"
Change in Behavioral Intentions Toward Alcohol Consumption
Change in behavioral intentions will be assessed with three items asking to what extent participants are determined to (i) reduce, (ii) completely stop, and (iii) commit to limiting their alcohol intake in the next 30 days, on a scale from 0 to 5, with higher scores indicating stronger intentions to modify alcohol consumption
Time frame: "Baseline" or "Day 1"
Intention to Stop Alcohol Consumption in the Next 30 Days
Participants will select the warning label option most likely to increase their intention to stop alcohol consumption in the next 30 days. Warning label alternatives vary by warning label type, warning label size, and alcohol type. The outcome will be measured as the frequency of selecting warning label alternatives perceived as most likely to increase intentions to stop alcohol consumption within the next 30 days.
Time frame: During Stage 2 of the single study visit, approximately 10-20 minutes
Intention to Purchase Alcohol Products in the Next 30 Days
Participants will select the warning label option most likely to decrease their intention to purchase alcohol products in the next 30 days. Warning label alternatives vary by warning label type, warning label size, and alcohol type. The outcome will be measured as the frequency of selecting warning label alternatives perceived as most likely to decrease intentions to purchase alcohol products within the next 30 days.
Time frame: During Stage 2 of the single study visit, approximately 10-20 minutes
Plan to share: No
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