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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03500965
Other study ID # P50CA180908A2a-T
Secondary ID P50CA180908
Status Completed
Phase N/A
First received February 14, 2018
Last updated April 9, 2018
Start date May 25, 2016
Est. completion date January 9, 2018

Study information

Verified date April 2018
Source Ohio State University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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, 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.


Recruitment information / eligibility

Status Completed
Enrollment 422
Est. completion date January 9, 2018
Est. primary completion date January 9, 2018
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 14 Years to 18 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Behavioral:
text-only PWL
control condition (no image)
graphic PWL
pictorial warning
absolute risk
Percentage risk information for smoking-related diseases for smokers
relative risk
Percentage risk information for smoking-related diseases for smokers and non-smokers

Locations

Country Name City State
n/a

Sponsors (2)

Lead Sponsor Collaborator
Ohio State University University of Pennsylvania

Outcome

Type Measure Description Time frame Safety issue
Primary 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 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
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