- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03499340
Pictorial Warning Labels & Memory for Relative & Absolute Cigarette Health-risk Information Over Time in Adult Smokers
April 13, 2018 updated by: Ellen Peters, Ohio State University
Pictorial cigarette warning labels (PWLs) are thought to increase risk knowledge, but experimental research has not examined PWLs' longer term effects on memory for health risks.
In this study, adult smokers are repeatedly exposed to text-only vs. low arousal graphic vs. high arousal graphic warning labels paired with numeric risk information.
This study will allow the investigators to assess the extent to which reactions to warnings remain consistent over time and influence smoking risk perceptions and quit intentions.
The investigators will also assess the impact of graphic images on memory for smoking risk information presented in absolute (a smoker's lifetime risk of getting a smoking related disease) versus relative (a smoker's risk of getting a smoking related disease, compared to the risk of non-smokers) formats.
Study Overview
Status
Completed
Conditions
Study Type
Interventional
Enrollment (Actual)
3213
Phase
- 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 Locations
-
-
Ohio
-
Columbus, Ohio, United States, 43210
- the Ohio State University
-
-
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
Ages Eligible for Study
19 years to 64 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- have smoked 100+ lifetime cigarettes
- currently smoke "every day" or "some days."
Exclusion Criteria:
- have not ever smoked a cigarette
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: Factorial Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Text-only PWL, absolute risk
Exposure to FDA-mandated warning labels, without a graphic image, accompanied by risk information about smoker's risk of a smoking-related disease
|
control condition (no image)
Percentage risk information for smoking-related diseases for smokers
|
Experimental: Text-only PWL, relative risk
Exposure to FDA-mandated warning labels, without a graphic image, accompanied by risk information about smoker's risk and non-smoker's risk of a smoking-related disease
|
control condition (no image)
Percentage risk information for smoking-related diseases for smokers and non-smokers
|
Experimental: Low arousal graphic PWL, absolute risk
Exposure to FDA-mandated warning labels, paired with a low arousal graphic image, accompanied by risk information about smoker's risk of a smoking-related disease
|
Percentage risk information for smoking-related diseases for smokers
pictorial warning
|
Experimental: Low arousal graphic PWL, relative risk
Exposure to FDA-mandated warning labels, paired with a low arousal graphic image, accompanied by risk information about smoker's risk and non-smoker's risk of a smoking-related disease
|
Percentage risk information for smoking-related diseases for smokers and non-smokers
pictorial warning
|
Experimental: High arousal graphic PWL, absolute risk
Exposure to FDA-mandated warning labels, paired with a high arousal graphic image, accompanied by risk information about smoker's risk of a smoking-related disease
|
Percentage risk information for smoking-related diseases for smokers
pictorial warning
|
Experimental: High arousal graphic PWL, relative risk
Exposure to FDA-mandated warning labels, paired with a high arousal graphic image, accompanied by risk information about smoker's risk and non-smoker's risk of a smoking-related disease
|
Percentage risk information for smoking-related diseases for smokers and non-smokers
pictorial warning
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
numeric risk recognition
Time Frame: measured immediately following last exposure
|
Participants answered one multiple choice question about the numeric risk for smokers for each label (e.g., ____% of smokers die before age 85).
For each question, there were four decoy responses.
|
measured immediately following last exposure
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
numeric risk recognition
Time Frame: measured after 6-week delay
|
Participants answered one multiple choice question about the numeric risk for smokers for each label (e.g., ____% of smokers die before age 85).
For each question, there were four decoy responses.
|
measured after 6-week delay
|
relative risk recognition
Time Frame: measured immediately following last exposure
|
Participants answered one multiple choice question about the numeric risk for smokers vs. nonsmokers for each health risk (e.g., a smoker is ____ as likely to die from heart disease as a nonsmoker).
For each question, there were three decoy responses (e.g., for heart disease, response options were: "about as likely," "1.75 times," "4.1 times," "10.4 times").
|
measured immediately following last exposure
|
relative risk recognition
Time Frame: measured after 6-week delay
|
Participants answered one multiple choice question about the numeric risk for smokers vs. nonsmokers for each health risk (e.g., a smoker is ____ as likely to die from heart disease as a nonsmoker).
For each question, there were three decoy responses (e.g., for heart disease, response options were: "about as likely," "1.75 times," "4.1 times," "10.4 times").
|
measured after 6-week delay
|
smoking risk perceptions
Time Frame: measured immediately following last exposure
|
Participants completed several scale items about how much risk they perceived smoking posed to them (e.g., "If a person smokes at your age, how likely are they to get a life-threatening illness from smoking someday ?" [1=very unlikely; 5=extremely likely])
|
measured immediately following last exposure
|
smoking risk perceptions
Time Frame: measured after 6-week delay
|
Participants completed several scale items about how much risk they perceived smoking posed to them (e.g., "If a person smokes at your age, how likely are they to get a life-threatening illness from smoking someday ?" [1=very unlikely; 5=extremely likely])
|
measured after 6-week delay
|
quit intentions (for next 30 days)
Time Frame: measured immediately following last exposure
|
Participants intentions to quit smoking; self-reported likelihood of smoking "within the next 30 days" (-3 = very unlikely, 3 = very likely)
|
measured immediately following last exposure
|
quit intentions (for next 30 days)
Time Frame: measured after 6-week delay
|
Participants intentions to quit smoking; self-reported likelihood of smoking "within the next 30 days" (-3 = very unlikely, 3 = very likely)
|
measured after 6-week delay
|
quit intentions (for next year)
Time Frame: measured immediately following last exposure
|
Participants intentions to quit smoking; self-reported likelihood of smoking "within next year" (-3 = very unlikely, 3 = very likely)
|
measured immediately following last exposure
|
quit intentions (for next year)
Time Frame: measured after 6-week delay
|
Participants intentions to quit smoking; self-reported likelihood of smoking "within next year" (-3 = very unlikely, 3 = very likely)
|
measured after 6-week delay
|
risk recognition
Time Frame: measured immediately following last exposure
|
Participants were given a list of 9 warnings and asked to select which ones they'd been previously exposed to
|
measured immediately following last exposure
|
risk recognition
Time Frame: measured after 6-week delay
|
Participants were given a list of 9 warnings and asked to select which ones they'd been previously exposed to
|
measured after 6-week delay
|
feelings about smoking
Time Frame: measured immediately following last exposure
|
Participants completed several scale items about their feelings towards smoking (e.g., "How good or bad do you feel about smoking?" -2=very bad; +2=very good; "How much do you feel confused about the harms vs. benefits of smoking?" 0=not at all confused; 4=very confused)
|
measured immediately following last exposure
|
feelings about smoking
Time Frame: measured after 6-week delay
|
Participants completed several scale items about their feelings towards smoking (e.g., "How good or bad do you feel about smoking?" -2=very bad; +2=very good; "How much do you feel confused about the harms vs. benefits of smoking?" 0=not at all confused; 4=very confused)
|
measured after 6-week delay
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
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)
July 10, 2017
Primary Completion (Actual)
October 3, 2017
Study Completion (Actual)
October 3, 2017
Study Registration Dates
First Submitted
April 9, 2018
First Submitted That Met QC Criteria
April 13, 2018
First Posted (Actual)
April 17, 2018
Study Record Updates
Last Update Posted (Actual)
April 17, 2018
Last Update Submitted That Met QC Criteria
April 13, 2018
Last Verified
April 1, 2018
More Information
Terms related to this study
Other Study ID Numbers
- P50CA180908A2a-A
- P50CA180908 (U.S. NIH Grant/Contract)
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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