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

• ClinicalTrials.gov Identifier: NCT03499340
• Recruitment Status: Completed
• First Posted: April 17, 2018
• Last Update Posted: April 17, 2018
• Sponsor: Ohio State University
• Collaborator: University of Pennsylvania
• Information provided by (Responsible Party): Ellen Peters, Ohio State University

Study Description

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

Study Design

• 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

Arms and Interventions

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

Outcome Measures

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)

Eligibility Criteria

• 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

Contacts and Locations

Locations

United States, Ohio

The Ohio State University

Columbus, Ohio, United States, 43210

Sponsors and Collaborators

Ohio State University

University of Pennsylvania

More Information

• 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
• Last Update Posted: April 17, 2018
• Last Verified: April 2018

• 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