Evaluations of Alcohol Warning Labels

October 30, 2025 updated by: Zexin Ma, University of Connecticut
The goal of this study is to determine the effectiveness of pictorial warning labels (PWLs) featuring narrative (vs. non-narrative) content in communicating the cancer risk of alcohol. Participants will be randomized to view either three narrative or non-narrative PWLs. Key outcome variables include visual attention, message reactance, risk perceptions, and intentions to reduce and stop drinking.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

The goal of this study is to determine the effectiveness of pictorial warning labels (PWLs) featuring narrative (vs. non-narrative) content in communicating the cancer risk of alcohol. Participants will be recruited from online panels. Participants will first be invited to participate in an online screening survey. Eligible participants will be invited to participate in the main experiment. In the main experiment, participants will first answer questions concerning baseline alcohol consumption and other background information. Then they will engage with a webcam-based eye-tracking task through Sticky by Tobii. Participants will first read instructions and tips related to completing the eye-tracking task. They will complete a brief calibration procedure and be presented with either three narrative PWLs or three non-narrative PWLs. Sticky by Tobii will record participants' gaze, thereby measuring visual attention to each PWL. After viewing each PWL, participants will answer a few questions. After viewing all three PWLs, they will answer questions based on all images combined. Upon study completion, participants will be compensated. A follow-up survey will be sent to participants after two weeks, which includes questions about their drinking behaviors, information seeking behaviors, and social interactions.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
1053

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • United States
    • Connecticut
      • Storrs, Connecticut, United States, 06269
        • Online Survey-Experiment

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  1. be at least 21 years old;
  2. have consumed more than three alcoholic drinks per week over the past year;
  3. be willing to participate in remote eye tracking tasks and have necessary technical support to complete remote eye tracking tasks (i.e., having access to high-speed Internet and a computer/tablet/phone equipped with a high-speed camera).

Exclusion Criteria:

  1. be younger than 21 years old;
  2. has not consumed more than three alcoholic drinks per week over the past year;
  3. be not willing to participate in remote eye tracking tasks and have no necessary technical support to complete remote eye tracking tasks (i.e., having access to high-speed Internet and a computer/tablet/phone equipped with a high-speed camera).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Narrative Pictorial Warning Labels
Participants in this arm will be presented with three narrative pictorial warning labels for alcoholic beverages.
Behavioral: Narrative pictorial warning labels for alcoholic beverages
Pictorial warning labels consisting of text and narrative imagery (e.g., photos of cancer patients) conveying the risk of alcohol for oral cancer, esophageal cancer, and larynx cancer.
Experimental: Non-Narrative Pictorial Warning Labels
Participants in this arm will be presented with three non-narrative pictorial warning labels for alcoholic beverages.
Behavioral: Non-narrative pictorial warning labels for alcoholic beverages
Pictorial warning labels consisting of text and non-narrative imagery (e.g., images of diseased organs) conveying the risk of alcohol for oral cancer, esophageal cancer, and larynx cancer.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Dwell Time
Time Frame: Assessed during the one-time 15-minute online survey experiment.
Dwell time measures the total duration of attention to an area of interest (AOI). Each warning label consisted of two AOIs: image AOI and text AOI. Dwell time for each AOI was averaged across three PWLs within each arm.
Assessed during the one-time 15-minute online survey experiment.
Visit Count
Time Frame: Assessed during the one-time 15-minute online survey experiment.
Visit count measures the total number of times participants viewed an area of interest (AOI). Each warning label consisted of two AOIs: image AOI and text AOI. Visit count for each AOI was averaged across three PWLs within each arm.
Assessed during the one-time 15-minute online survey experiment.
Reactance
Time Frame: Assessed during the one-time 15-minute online survey experiment.
Reactance were measured after exposure to each PWL (i.e., three times in total). It was assessed using the brief Reactance to Health Warnings Scale (Hall et al., 2017). Participants were asked to indicate how much each warning tried to manipulate them, annoyed them, and was overblown (1 = not at all, 5 = a great deal). Reactance for each PWL was averaged across three PWLs within each arm.
Assessed during the one-time 15-minute online survey experiment.
Affective Risk Perceptions
Time Frame: Assessed during the one-time 15-minute online survey experiment.
Affective risk perceptions were assessed once after participants viewed all three PWLs. Participants were asked to indicate how worried they are about getting a specific type of cancer if they keep drinking the amount of alcohol like they do now. Participants responded on a five-point scale (1 = Not at all worried, 2=Slightly worried, 3=Moderately worried, 4=Very worried, 5=Extremely worried).
Assessed during the one-time 15-minute online survey experiment.
Experiential Risk Perceptions
Time Frame: Assessed during the one-time 15-minute online survey experiment.
Experiential risk perceptions were assessed once after participants viewed all three PWLs. Participants were asked to indicate how vulnerable they feel about getting a specific type of cancer if they keep drinking the amount of alcohol like they do now. Participants responded on a five-point scale (1 = Not at all vulnerable, 2=Slightly vulnerable, 3=Moderately vulnerable, 4=Very vulnerable, 5=Extremely vulnerable).
Assessed during the one-time 15-minute online survey experiment.
Perceived Susceptibility
Time Frame: Assessed during the one-time 15-minute online survey experiment.
Perceived susceptibility were assessed once after participants viewed all three PWLs. Participants were asked to indicate how likely it is that they will get a specific type of cancer if they keep drinking the amount of alcohol like they do now. Participants responded on a five-point scale (1 = Not at all likely, 2=A little likely, 3=Somewhat likely, 4=Very likely, 5=Extremely likely).
Assessed during the one-time 15-minute online survey experiment.
Comparative Risk
Time Frame: Assessed during the one-time 15-minute online survey experiment.
Comparative risk were assessed once after participants viewed all three PWLs. Participants were asked to indicate compared to an average person their age, race, and sex, how likely do they think they will get a specific type of cancer if they keep drinking the amount of alcohol like they do now. Participants responded on a five-point scale (1=Much less likely, 2=Less likely, 3=About as likely, 4=More likely, 5=Much more likely).
Assessed during the one-time 15-minute online survey experiment.
Perceived Severity of Harm
Time Frame: Assessed during the one-time 15-minute online survey experiment.
Perceived severity of harm were assessed once after participants viewed all three PWLs. Participants were asked to indicate how much getting a specific type of cancer because of drinking would affect their life. Participants responded on a five-point scale (1=Not at all, 2=Very little, 3=Somewhat, 4=Quite a bit, 5=A great deal).
Assessed during the one-time 15-minute online survey experiment.
Intentions to Reduce Drinking
Time Frame: Assessed during the one-time 15-minute online survey experiment.
Intentions to reduce drinking were assessed once after participants viewed all three PWLs. Participants were asked to answer questions such as "How interested are you in reducing drinking in the next 6 months?" Participants responded to these questions on an appropriately labeled 5-point scale (e.g., 1 = Not at all interested, 2=Slightly interested, 3=Moderately interested, 4=Very interested, 5=Extremely interested).
Assessed during the one-time 15-minute online survey experiment.
Intentions to Stop Drinking
Time Frame: Assessed during the one-time 15-minute online survey experiment.
Intentions to stop drinking were assessed once after participants viewed all three PWLs. Participants were asked to answer three questions such as "How interested are you in stopping drinking in the next 6 months?" Participants responded to these questions on an appropriately labeled 5-point scale (e.g., 1 = Not at all interested, 2=Slightly interested, 3=Moderately interested, 4=Very interested, 5=Extremely interested).
Assessed during the one-time 15-minute online survey experiment.

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Attitudes toward alcohol
Time Frame: Immediately after the intervention
Attitudes toward alcohol will be assessed by three semantic differential items on a five-point scale. Participants will be presented with a statement (i.e., Now, please think about how you feel about alcohol at this moment. Do you think drinking alcohol is ____) followed by adjectives such as "Bad/Good," "Unenjoyable/Enjoyable," and "Harmful/Beneficial."
Immediately after the intervention
Intentions to avoid the warnings
Time Frame: Immediately after the intervention
Intentions to avoid the warnings will be assessed by three questions, such as "If all alcoholic beverages had these warnings on them, how likely is it that you would cover them up?" Participants will respond on a five-point scale (1=Not at all likely, 2=Slightly likely, 3=Somewhat likely, 4=Very likely, 5=Extremely likely).
Immediately after the intervention
Policy support
Time Frame: Immediately after the intervention
Policy support will be measured by three questions, such as "If the U.S. required that these warnings appeared on alcoholic beverages, to what extent would you support or oppose this policy?" Participants will respond to these questions on an appropriately labeled 5-point scale (e.g., 1 = Strongly oppose, 5 = Strongly support).
Immediately after the intervention
Self-reported behavior change due to labels
Time Frame: Two-week follow up
Self-reported behavior change due to labels will be measured with one question, "In the past two weeks, has the amount of alcohol you are drinking changed as a result of the alcohol warning labels you previously saw? Are you drinking ...?" Participants will respond on a five-point scale (1=Much less, 2=A bit less, 3=Same amount, 4=A bit more, 5=Much more).
Two-week follow up
Information seeking
Time Frame: Two-week follow up
Information seeking will be measured by two question, such as "In the past two weeks, how many times did you talk to a doctor or other health professional about the cancer risks of alcohol?" Participants will respond on a five-point scale (1=Never, 2=1-2 times, 3=3-4 times, 4=5-9 times, 5=10 or more times).
Two-week follow up
Social interactions
Time Frame: Two-week follow up
Social interactions will be measured by four questions, such as"In the past two weeks, how many times did you talk to people other than your doctor about the cancer risks of alcohol?" Participants will respond on a five-point scale (=Never, 2=1-2 times, 3=3-4 times, 4=5-9 times, 5=10 or more times).
Two-week follow up

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Self-reported attention
Time Frame: Immediately after the intervention
Self-reported attention will be measured by one question, "How much did this warning grab your attention?" Participants will respond on a five-point scale (1=Not at all, 2=Very little, 3=Somewhat, 4=Quite a bit, 5=A great deal).
Immediately after the intervention
Self-reported avoidance
Time Frame: Immediately after the intervention
Self-reported avoidance will be measured by one question, "How much did this warning make you want to look away?" Participants will respond on a five-point scale (1=Not at all, 2=Very little, 3=Somewhat, 4=Quite a bit, 5=A great deal).
Immediately after the intervention
Narrative construction
Time Frame: Immediately after the intervention
Narrative construction will be measured with four questions, such as "How much did you try to tell yourself a story when viewing this warning?" Participants will respond on a five-point scale (1=Not at all, 2=Very little, 3=Somewhat, 4=Quite a bit, 5=A great deal).
Immediately after the intervention
Processing fluency
Time Frame: Immediately after the intervention
Processing fluency will be measured with two questions, such as "How easy or difficult was it to process the information shown in the warnings?"Participants will respond on a five-point scale (11=Very difficult, 2=Somewhat difficult, 3=Neither difficult nor easy, 4=Somewhat easy, 5=Very easy).
Immediately after the intervention
Affect
Time Frame: Immediately after the intervention
Participants will report how they felt while viewing the labels. Fear, disgust, anger, sadness, and sympathy will be measured using established scales. Participants will respond on a five-point scale (1=Not at all, 2=Very little, 3=Somewhat, 4=Quite a bit, 5=A great deal).
Immediately after the intervention
Cognitive elaboration
Time Frame: Immediately after the intervention
Cognitive elaboration will be measured by four questions, such as "How much did the warnings make you think about reasons for not drinking?" Participants will respond on a five-point scale (1=Not at all, 2=Very little, 3=Somewhat, 4=Quite a bit, 5=A great deal).
Immediately after the intervention
Retrospective reflection
Time Frame: Immediately after the intervention
Retrospective reflection will be measured by three questions, such as "When viewing, the warnings reminded you of some of your personal experiences?" Participants will respond on a five-point scale (1=Not at all, 2=Very little, 3=Somewhat, 4=Quite a bit, 5=A great deal).
Immediately after the intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Connecticut

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
National Cancer Institute (NCI)
Oakland University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Zexin Ma, Ph.D., University of Connecticut

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 19, 2024

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 6, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 27, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 2, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 8, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 13, 2023

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 14, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 30, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • B2023-0021
  • 7R03CA273391-02 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

The de-identified dataset, study protocol, sample informed consent, and data dictionary will be made available to the research community free of charge through ICPSR (https://www.openicpsr.org/).

IPD Sharing Time Frame

Datasets will be shared upon the publication of the manuscripts and will be available to the research community in perpetuity.

IPD Sharing Access Criteria

All de-identified study data use will be made available as public use data to the research community through ICPSR. Users of the public use data must register with ICPSR and agree to the Terms of Use, which are designed to protect study participants by limiting data use to scientific research and aggregate statistical reporting, prohibiting attempts to identify study participants, and requiring immediate reporting of any disclosure of study participant identity. Data users also agree not to share or redistribute any data downloads.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • ICF

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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