Pictorial Warning Labels and Memory for Relative and Absolute Cigarette Health-risk Information Over Time in Teens

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, teens who have experimented with smoking or are considered vulnerable to smoking are repeatedly exposed to text-only vs. graphic warning labels paired with numeric risk information. This study will allow us to assess the extent to which reactions to warnings remain consistent over time and influence future smoking intentions. We will also assess the impact of graphic images on memory for smoking risk information presented in absolute and (a smokers lifetime risk of getting a smoking related disease), or relative (a smokers risk of getting a smoking related disease, compared to the risk of non-smokers) formats.

Study Overview

• Status: Completed
• Conditions: Smoking Cessation; Smoking, Cigarette
• Intervention / Treatment: Behavioral: text-only PWL; Behavioral: absolute risk; Behavioral: relative risk; Behavioral: graphic PWL

• Study Type: Interventional
• Enrollment (Actual): 422
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 18 years (Child, Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• have ever tried smoking
• report vulnerability to smoking (i.e., report that they might smoke in the next year or would try a cigarette if a friend offered one)
• parents give permission to participate

Exclusion Criteria:

• not vulnerable to smoking (i.e., report they will definitely not smoke a cigarette in the next year and definitely would not try a cigarette if one was offered
• parents do not provide permission to participate

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Factorial Assignment
• Masking: Double

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Text-only PWL, absol 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: graphic PWL, absol risk; Exposure to FDA-mandated warning labels, paired with a graphic image, accompanied by risk information about smoker's risk of a smoking-related disease	Behavioral: absolute risk; Percentage risk information for smoking-related diseases for smokers; Behavioral: graphic PWL; pictorial warning
Experimental: graphic PWL, relative risk; Exposure to FDA-mandated warning labels, paired with a graphic image, accompanied by risk information about smoker's risk and non-smoker's risk of a smoking-related disease	Behavioral: relative risk; Percentage risk information for smoking-related diseases for smokers and non-smokers; Behavioral: graphic PWL; pictorial warning

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
numeric risk recognition	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	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	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	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	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	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
risk recognition	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	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	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	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
quit intentions (for next 30 days)	Participants intentions to quit smoking; self-reported likelihood of smoking "within the next 30 days" (-3 = very unlikely, 3 = very likely) (only for those teens who currently smoked)	measured immediately following last exposure
quit intentions (for next 30 days)	Participants intentions to quit smoking; self-reported likelihood of smoking "within the next 30 days" (-3 = very unlikely, 3 = very likely) (only for those teens who currently smoked)	measured after 6-week delay
quit intentions (for next year)	Participants intentions to quit smoking; self-reported likelihood of smoking "within the next year" (-3 = very unlikely, 3 = very likely) only for those teens who currently smoked	measured immediately following last exposure
quit intentions (for next year)	Participants intentions to quit smoking; self-reported likelihood of smoking "within the next year" (-3 = very unlikely, 3 = very likely) only for those teens who currently smoked	measured after 6-week delay

Collaborators and Investigators

• Sponsor: Ohio State University
• Collaborators: University of Pennsylvania

Study record dates

Study Major Dates

• Study Start (Actual): May 25, 2016
• Primary Completion (Actual): January 9, 2018
• Study Completion (Actual): January 9, 2018

Study Registration Dates

• First Submitted: February 14, 2018
• First Submitted That Met QC Criteria: April 9, 2018
• First Posted (Actual): April 18, 2018

Study Record Updates

• Last Update Posted (Actual): April 18, 2018
• Last Update Submitted That Met QC Criteria: April 9, 2018
• Last Verified: April 1, 2018

More Information

Terms related to this study

• Keywords: memory; emotion; pictorial warning labels; risk knowledge; risk perceptions; quit intentions
• Other Study ID Numbers: P50CA180908A2a-T; 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