Evaluations of Alcohol Warning Labels

Sponsor
University of Connecticut (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT06129487
Collaborator
Oakland University (Other), National Cancer Institute (NCI) (NIH)
800
2
2

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Narrative pictorial warning labels for alcoholic beverages
  • Behavioral: Non-narrative pictorial warning labels for alcoholic beverages
N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
800 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Participant)
Primary Purpose:
Prevention
Official Title:
Evaluations of Alcohol Warning Labels
Anticipated Study Start Date :
Nov 1, 2023
Anticipated Primary Completion Date :
Dec 1, 2023
Anticipated Study Completion Date :
Jan 1, 2024

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. Attention 1 [During the intervention]

    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.

  2. Attention 2 [During the intervention]

    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.

  3. Attention 3 [During the intervention]

    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.

  4. Reactance [Immediately after the intervention]

    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).

  5. Affective risk perceptions [Immediately after the intervention]

    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).

  6. Experiential risk perceptions [Immediately after the intervention]

    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).

  7. Perceived susceptibility [Immediately after the intervention]

    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).

  8. Comparative risk [Immediately after the intervention]

    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).

  9. Perceived severity of harm [Immediately after the intervention]

    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).

  10. Intentions to reduce drinking [Immediately after the intervention]

    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).

  11. Intentions to stop drinking [Immediately after the intervention]

    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).

Secondary Outcome Measures

  1. Attitudes toward alcohol [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."

  2. Intentions to avoid the warnings [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).

  3. Policy support [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).

  4. Self-reported behavior change due to labels [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).

  5. Information seeking [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).

  6. Social interactions [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).

Other Outcome Measures

  1. Self-reported attention [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).

  2. Self-reported avoidance [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).

  3. Narrative construction [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).

  4. Processing fluency [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).

  5. Affect [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).

  6. Cognitive elaboration [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).

  7. Retrospective reflection [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).

Eligibility Criteria

Criteria

Ages Eligible for Study:
21 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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).

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • University of Connecticut
  • Oakland University
  • National Cancer Institute (NCI)

Investigators

  • Principal Investigator: Zexin Ma, Ph.D., University of Connecticut

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Zexin Ma, Assistant Professor, University of Connecticut
ClinicalTrials.gov Identifier:
NCT06129487
Other Study ID Numbers:
  • B2023-0021
  • 7R03CA273391-02
First Posted:
Nov 13, 2023
Last Update Posted:
Nov 13, 2023
Last Verified:
Nov 1, 2023
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Nov 13, 2023