Evaluations of Alcohol Warning Labels

Esophageal Cancer Clinical Trial

Official title:

Evaluations of Alcohol Warning Labels

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06129487
• Other study ID #: B2023-0021
• Secondary ID: 7R03CA273391-02
• Status: Completed
• Phase: N/A
• Start date: January 19, 2024
• Est. completion date: March 27, 2024

Study information

• Verified date: March 2024
• Source: University of Connecticut
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 649
• Est. completion date: March 27, 2024
• Est. primary completion date: March 6, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 21 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Alcohol Drinking
• Esophageal Cancer
• Laryngeal Neoplasms
• Larynx Cancer
• Mouth Neoplasms
• Oral Cancer

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	Online Survey-Experiment	Storrs	Connecticut

Sponsors (3)

Lead Sponsor	Collaborator
University of Connecticut	National Cancer Institute (NCI), Oakland University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	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
Other	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
Other	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
Other	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
Other	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
Other	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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