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

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.

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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