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Pictorial Warning Labels & Memory for Relative & Absolute Cigarette Health-risk Information Over Time in Adult Smokers

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03499340
Recruitment Status : Completed
First Posted : April 17, 2018
Last Update Posted : April 17, 2018
Sponsor:
Collaborator:
University of Pennsylvania
Information provided by (Responsible Party):
Ellen Peters, Ohio State University

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Smoking Cessation Smoking, Cigarette Behavioral: text-only PWL Behavioral: low arousal graphic PWL Behavioral: high arousal graphic PWL Behavioral: absolute risk Behavioral: relative risk Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 3213 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Pictorial Warning Labels & Memory for Relative & Absolute Cigarette Health-risk Information Over Time in Adult Smokers
Actual Study Start Date : July 10, 2017
Actual Primary Completion Date : October 3, 2017
Actual Study Completion Date : October 3, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Memory

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
Behavioral: text-only PWL
control condition (no image)

Behavioral: absolute risk
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
Behavioral: text-only PWL
control condition (no image)

Behavioral: relative risk
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
Behavioral: low arousal graphic PWL
pictorial warning

Behavioral: absolute risk
Percentage risk information for smoking-related diseases for smokers

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
Behavioral: low arousal graphic PWL
pictorial warning

Behavioral: relative risk
Percentage risk information for smoking-related diseases for smokers and non-smokers

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
Behavioral: high arousal graphic PWL
pictorial warning

Behavioral: absolute risk
Percentage risk information for smoking-related diseases for smokers

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
Behavioral: high arousal graphic PWL
pictorial warning

Behavioral: relative risk
Percentage risk information for smoking-related diseases for smokers and non-smokers




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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").

  3. 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").

  4. 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])

  5. 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])

  6. 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)

  7. 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)

  8. 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)

  9. 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)

  10. 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

  11. 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

  12. 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)

  13. 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)



Information from the National Library of Medicine

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Ages Eligible for Study:   19 Years to 64 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • have smoked 100+ lifetime cigarettes
  • currently smoke "every day" or "some days."

Exclusion Criteria:

  • have not ever smoked a cigarette

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03499340


Locations
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United States, Ohio
The Ohio State University
Columbus, Ohio, United States, 43210
Sponsors and Collaborators
Ohio State University
University of Pennsylvania

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Responsible Party: Ellen Peters, Professor, Ohio State University
ClinicalTrials.gov Identifier: NCT03499340    
Other Study ID Numbers: P50CA180908A2a-A
P50CA180908 ( U.S. NIH Grant/Contract )
First Posted: April 17, 2018    Key Record Dates
Last Update Posted: April 17, 2018
Last Verified: April 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Ellen Peters, Ohio State University:
pictorial warning labels
risk knowledge
emotion
memory
risk perceptions
quit intentions