Evaluations of Alcohol Warning Labels

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: Completed
• Conditions: Alcohol Drinking; Esophageal Cancer; Oral Cancer; Larynx Cancer
• Intervention / Treatment: Behavioral: Narrative pictorial warning labels for alcoholic beverages; Behavioral: Non-narrative pictorial warning labels for alcoholic beverages

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: Interventional
• Enrollment (Actual): 649
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

Outcome Measure	Measure Description	Time Frame
Attention 1	Attention 1 to each label will use the eye-tracking metrics time until noticed, which measures the time between stimulus onset and the arrival of the participant's gaze into a specific area of interest.	During the intervention
Attention 2	Attention 2 to each label will use the eye-tracking metrics time viewed, which measures the average amount of time spent on an area of interest.	During the intervention
Attention 3	Attention 3 to each label will use the eye-tracking metrics number of visits, which measures the total number of unique times the area of interest was viewed.	During the intervention
Reactance	Reactance will be measured with three questions, such as "How much did the warning try to manipulate you?" 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
Affective risk perceptions	Affective risk perceptions will be assessed by asking participants 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 will respond on a five-point scale (1 = Not at all worried, 2=Slightly worried, 3=Moderately worried, 4=Very worried, 5=Extremely worried).	Immediately after the intervention
Experiential risk perceptions	Experiential risk perceptions will be assessed by asking participants 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 will respond on a five-point scale (1 = Not at all vulnerable, 2=Slightly vulnerable, 3=Moderately vulnerable, 4=Very vulnerable, 5=Extremely vulnerable).	Immediately after the intervention
Perceived susceptibility	Perceived susceptibility will be assessed by asking participants 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 will respond on a five-point scale (1 = Not at all likely, 2=A little likely, 3=Somewhat likely, 4=Very likely, 5=Extremely likely).	Immediately after the intervention
Comparative risk	Comparative risk will be assessed by asking participants 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 will respond on a five-point scale (1=Much less likely, 2=Less likely, 3=About as likely, 4=More likely, 5=Much more likely).	Immediately after the intervention
Perceived severity of harm	Perceived severity of harm will be assessed by asking participants to indicate how much getting a specific type of cancer because of drinking would affect their life. 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
Intentions to reduce drinking	Intentions to reduce drinking will be assessed with three questions such as "How interested are you in reducing drinking in the next 6 months?" Participants will respond 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).	Immediately after the intervention
Intentions to stop drinking	Intentions to stop drinking will be assessed with three questions such as "How interested are you in stopping drinking in the next 6 months?" Participants will respond 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).	Immediately after the intervention

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Attitudes toward alcohol	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	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	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	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	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	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

Outcome Measure	Measure Description	Time Frame
Self-reported attention	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	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	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	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	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	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	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

• Sponsor: University of Connecticut
• Collaborators: National Cancer Institute (NCI); Oakland University
• Investigators: Principal Investigator: Zexin Ma, Ph.D., University of Connecticut

Study record dates

Study Major Dates

• Study Start (Actual): January 19, 2024
• Primary Completion (Actual): March 6, 2024
• Study Completion (Actual): March 27, 2024

Study Registration Dates

• First Submitted: November 2, 2023
• First Submitted That Met QC Criteria: November 8, 2023
• First Posted (Actual): November 13, 2023

Study Record Updates

• Last Update Posted (Actual): April 1, 2024
• Last Update Submitted That Met QC Criteria: March 29, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Drinking Behavior; Respiratory Tract Diseases; Neoplasms; Neoplasms by Site; Respiratory Tract Neoplasms; Otorhinolaryngologic Neoplasms; Head and Neck Neoplasms; Stomatognathic Diseases; Otorhinolaryngologic Diseases; Mouth Diseases; Laryngeal Diseases; Alcohol Drinking; Mouth Neoplasms; Laryngeal Neoplasms
• Other Study ID 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