Evaluations of Alcohol Warning Labels

NCT06129487 | Completed Results

• 2 other identifiers: B2023-00217R03CA273391-02
• Study Type: interventional
• Target: 1,053
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Oral Cancer; Esophageal Cancer; Larynx Cancer; Alcohol Drinking

Outcome Measures

Primary Outcomes (10)

• Dwell Time

  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

  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

  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

  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

  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

  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

  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

  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

  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

  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.

Study Arms (2)

Narrative Pictorial Warning Labels

EXPERIMENTAL

Participants in this arm will be presented with three narrative pictorial warning labels for alcoholic beverages.

Behavioral: Narrative pictorial warning labels for alcoholic beverages

Non-Narrative Pictorial Warning Labels

EXPERIMENTAL

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

Interventions

Narrative pictorial warning labels for alcoholic beverages BEHAVIORAL

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.

Narrative Pictorial Warning Labels

Non-narrative pictorial warning labels for alcoholic beverages BEHAVIORAL

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.

Non-Narrative Pictorial Warning Labels

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• be at least 21 years old;
• have consumed more than three alcoholic drinks per week over the past year;
• 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).

You may not qualify if:

• be younger than 21 years old;
• has not consumed more than three alcoholic drinks per week over the past year;
• 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).

Sponsors & Collaborators

• University of Connecticut: lead
• Oakland University: collaborator
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Online Survey-Experiment

Storrs, Connecticut, 06269, United States

Location

MeSH Terms

Conditions

Mouth Neoplasms; Esophageal Neoplasms; Laryngeal Neoplasms; Alcohol Drinking

Interventions

Alcoholic Beverages

Condition Hierarchy (Ancestors)

Head and Neck Neoplasms; Neoplasms by Site; Neoplasms; Mouth Diseases; Stomatognathic Diseases; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Esophageal Diseases; Gastrointestinal Diseases; Otorhinolaryngologic Neoplasms; Laryngeal Diseases; Respiratory Tract Diseases; Respiratory Tract Neoplasms; Otorhinolaryngologic Diseases; Drinking Behavior; Behavior

Intervention Hierarchy (Ancestors)

Beverages; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Results Point of Contact

• Title: Zexin Ma, Ph.D.
• Organization: University of Connecticut

zexin.ma@uconn.edu

(860) 486-6871

Study Officials

• Zexin Ma, Ph.D.

  University of Connecticut

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: November 2, 2023
• First Posted: November 13, 2023
• Study Start: January 19, 2024
• Primary Completion: March 6, 2024
• Study Completion: March 27, 2024
• Last Updated: November 14, 2025
• Results First Posted: November 14, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: Datasets will be shared upon the publication of the manuscripts and will be available to the research community in perpetuity.
• 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.

Locations

US (1)