Smoking CessationNCT03500965
Pictorial Warning Labels and Memory for Relative and Absolute Cigarette Health-risk Information Over Time in Teens
A study testing text-only PWL, graphic PWL and absolute risk in people with Smoking Cessation and Smoking, Cigarette, run by Ohio State University.
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. Read more about this study
- Who is it for?
- Ages 14 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Smoking Cessation, Smoking, Cigarette
- What is being tested?
- text-only PWL, graphic PWL and absolute risk
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 422 participants
- Where
- No sites listed yet
- Study dates
- 25 May 2016to 9 Jan 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 14 to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- 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
Who cannot join
- 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
About this study
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.
- Conditions
- Smoking Cessation, Smoking, Cigarette
- Being tested
- text-only PWL, graphic PWL, absolute risk, relative risk
- Keywords
- pictorial warning labels, risk knowledge, emotion, memory, risk perceptions, quit intentions
- Medical subject headings
- Smoking Cessation, Cigarette Smoking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
text-only PWLBehavioural
control condition (no image)
graphic PWLBehavioural
pictorial warning
absolute riskBehavioural
Percentage risk information for smoking-related diseases for smokers
relative riskBehavioural
Percentage risk information for smoking-related diseases for smokers and non-smokers
| Study group | Role | What they receive |
|---|---|---|
| Text-only PWL, absol risk | Experimental | Exposure to FDA-mandated warning labels, without a graphic image, accompanied by risk information about smoker's risk of a smoking-related disease Receives: Behavioral: text-only PWL; Behavioral: absolute risk |
| text-only PWL, relative risk | Experimental | 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 Receives: Behavioral: text-only PWL; Behavioral: relative risk |
| graphic PWL, absol risk | Experimental | Exposure to FDA-mandated warning labels, paired with a graphic image, accompanied by risk information about smoker's risk of a smoking-related disease Receives: Behavioral: graphic PWL; Behavioral: absolute risk |
| graphic PWL, relative risk | Experimental | 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 Receives: Behavioral: graphic PWL; Behavioral: relative risk |
What is being measured
The primary outcome is the main question the study is designed to answer.
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: measured immediately following last exposure
Secondary outcomes (13)
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: 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: 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: 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: 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: 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: 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: 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: 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: 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: 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: 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: 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: measured after 6-week delay
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2018
- Study start25 May 2016
- Primary completion9 Jan 2018
- Study completion9 Jan 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Smoking CessationStudies of the same condition, open and under way.
- More trials run by Ohio State UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 422 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ohio State University
- Sponsor type
- University, hospital or other
- Collaborators
- University of Pennsylvania
- Responsible party
- Principal investigator, Ellen Peters, Ohio State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03500965
- Sponsor's protocol ID
- P50CA180908A2a-T
- Other IDs
- P50CA180908
- Status last verified
- Apr 2018
- First submitted
- 14 Feb 2018
- Last updated
- 18 Apr 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pictorial Warning Labels and Memory for Relative and Absolute Cigarette Health-risk Information Over Time in Teens
- ClinicalTrials.gov ID
- NCT03500965
- Acronym / sponsor ID
- P50CA180908A2a-T
- Conditions
- Smoking Cessation, Smoking, Cigarette
- Keywords
- pictorial warning labels, risk knowledge, emotion, memory, risk perceptions, quit intentions
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 422 participants (actual)
- Lead sponsor
- Ohio State UniversityUniversity, hospital or other
- Collaborators
- University of Pennsylvania
- Study start
- 25 May 2016 (actual)
- Primary completion
- 9 Jan 2018 (actual)
- Study completion
- 9 Jan 2018 (actual)
- First posted
- 18 Apr 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Text-only PWL, absol risk | Experimental | Behavioral: text-only PWL, Behavioral: absolute riskExposure to FDA-mandated warning labels, without a graphic image, accompanied by risk information about smoker's risk of a smoking-related disease |
| text-only PWL, relative risk | Experimental | Behavioral: text-only PWL, Behavioral: relative riskExposure 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 |
| graphic PWL, absol risk | Experimental | Behavioral: graphic PWL, Behavioral: absolute riskExposure to FDA-mandated warning labels, paired with a graphic image, accompanied by risk information about smoker's risk of a smoking-related disease |
| graphic PWL, relative risk | Experimental | Behavioral: graphic PWL, Behavioral: relative riskExposure 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 |
Who may qualify
- Ages
- 14 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| text-only PWLcontrol condition (no image) | Behavioural | Text-only PWL, absol risk, text-only PWL, relative risk |
| graphic PWLpictorial warning | Behavioural | graphic PWL, absol risk, graphic PWL, relative risk |
| absolute riskPercentage risk information for smoking-related diseases for smokers | Behavioural | Text-only PWL, absol risk, graphic PWL, absol risk |
| relative riskPercentage risk information for smoking-related diseases for smokers and non-smokers | Behavioural | graphic PWL, relative risk, text-only PWL, relative risk |
Primary outcome
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.
13 secondary outcomes
numeric risk recognition
Time frame: measured after 6-week delay
relative risk recognition
Time frame: measured immediately following last exposure
relative risk recognition
Time frame: measured after 6-week delay
smoking risk perceptions
Time frame: measured immediately following last exposure
smoking risk perceptions
Time frame: measured after 6-week delay
quit intentions (for next 30 days)
Time frame: measured immediately following last exposure
quit intentions (for next 30 days)
Time frame: measured after 6-week delay
quit intentions (for next year)
Time frame: measured immediately following last exposure
quit intentions (for next year)
Time frame: measured after 6-week delay
risk recognition
Time frame: measured immediately following last exposure
risk recognition
Time frame: measured after 6-week delay
feelings about smoking
Time frame: measured immediately following last exposure
feelings about smoking
Time frame: measured after 6-week delay
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Apr 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing text-only PWL, graphic PWL and absolute risk in people with Smoking Cessation and Smoking, Cigarette, run by Ohio State University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
numeric risk recognition (time frame: measured immediately following last exposure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Apr 2018.