Smoking, CigaretteNCT03501472
Pictorial Warning Labels, Numeracy, and Memory for Numeric Cigarette Health-risk Information Over Time
A study testing text-only PWL, low-emot PWL and high-emot PWL in people with Smoking, Cigarette and Smoking Cessation, 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, or for numeric risks (e.g., percentage risk for developing lung cancer). Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Smoking, Cigarette, Smoking Cessation
- What is being tested?
- text-only PWL, low-emot PWL and high-emot PWL
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 866 participants
- Where
- No sites listed yet
- Study dates
- 16 Apr 2016to 2 Jun 2016
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- at least 18 years old
- have smoked 100+ lifetime cigarettes
- currently smoke "every day" or "some days."
- US resident
Who cannot join
- have not ever smoked a cigarette
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, or for numeric risks (e.g., percentage risk for developing lung cancer). This trial tests memory for numeric health risks immediately or after a six-week delay for US adult smokers. In addition, the trial tests the effects of different warning label components (e.g., whether the numeric risks are percentage or frequency), participants' level of numeric ability, and the consequences of memory for numeric risks on participant risk perceptions and quit intentions.
- Conditions
- Smoking, Cigarette, Smoking Cessation
- Being tested
- text-only PWL, low-emot PWL, high-emot PWL, immed posttest, delay posttest
- Keywords
- pictorial warning labels, risk knowledge, emotion, memory, risk perceptions, quit intentions, numeracy
- Medical subject headings
- Cigarette Smoking, Smoking Cessation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
text-only PWLBehavioural
low-emot PWLBehavioural
high-emot PWLBehavioural
immed posttestBehavioural
delay posttestBehavioural
| Study group | Role | What they receive |
|---|---|---|
| Text-only PWL, immediate post | Experimental | Exposure to 4 FDA-mandated warning labels and numeric risk information for 8 outcomes related to those warnings (2 outcomes for each PWL; half as percentage, half as frequency)
Posttest measures (e.g., memory, risk perceptions, quit intentions) administered immediately following last exposure to warning labels Receives: Behavioral: text-only PWL; Behavioral: immed posttest |
| Text-only PWL, delay posttest | Experimental | Exposure to 4 FDA-mandated warning labels and numeric risk information for 8 outcomes related to those warnings (2 outcomes for each PWL; half as percentage, half as frequency)
Posttest measures (e.g., memory, risk perceptions, quit intentions) administered 6 weeks following last exposure to warning labels Receives: Behavioral: text-only PWL; Behavioral: delay posttest |
| Low-emot PWL, immed post | Experimental | Exposure to 4 FDA-mandated warning labels paired with images that elicit little emotion and numeric risk information for 8 outcomes related to those warnings (2 outcomes for each PWL; half as percentage, half as frequency)
Posttest measures (e.g., memory, risk perceptions, quit intentions) administered immediately following last exposure to warning labels Receives: Behavioral: low-emot PWL; Behavioral: immed posttest |
| Low-emot PWL, delay posttest | Experimental | Exposure to 4 FDA-mandated warning labels paired with images that elicit little emotion and numeric risk information for 8 outcomes related to those warnings (2 outcomes for each PWL; half as percentage, half as frequency)
Posttest measures (e.g., memory, risk perceptions, quit intentions) administered 6 weeks following last exposure to warning labels Receives: Behavioral: low-emot PWL; Behavioral: delay posttest |
| High-emot PWL, immed posttest | Experimental | Exposure to 4 FDA-mandated warning labels paired with images that elicit high emotion and numeric risk information for 8 outcomes related to those warnings (2 outcomes for each PWL; half as percentage, half as frequency)
Posttest measures (e.g., memory, risk perceptions, quit intentions) administered immediately following last exposure to warning labels Receives: Behavioral: high-emot PWL; Behavioral: immed posttest |
| High-emot PWL, delay posttest | Experimental | Exposure to 4 FDA-mandated warning labels paired with images that elicit high emotion and numeric risk information for 8 outcomes related to those warnings (2 outcomes for each PWL; half as percentage, half as frequency)
Posttest measures (e.g., memory, risk perceptions, quit intentions) administered 6 weeks following last exposure to warning labels Receives: Behavioral: high-emot PWL; Behavioral: delay posttest |
What is being measured
The primary outcome is the main question the study is designed to answer.
numeric risk recall
free recall for numeric risks presented in labels (e.g., ____% of smokers die before age 85), both for smokers and nonsmokers
Measured: immediately following last exposure or after 6-week delay
numeric risk recognition
Participants answered one multiple choice question about the numeric risk for smokers and nonsmokers (combined in one question) for each of the 8 outcomes that had been paired with the PWLs. For each question, there were four decoy responses.
Measured: immediately following last exposure or after 6-week delay
Secondary outcomes (3)
smoking risk perceptions
Participants completed several scale items about how much risk they perceived smoking posed to them (e.g., "Compared to the average nonsmoker your age, gender, and race, how would you rate your chances of": 1) "getting a life threatening illness because of smoking," 2) "getting lung cancer," and 3) "dying at a younger age than average" (-3 = Much lower, +3 = Much higher))
They also gave verbal likelihood ratings for each of the 8 outcomes of smoking that had been paired with the labels (e.g., "Thinking of risks that you were shown in the warnings, what is the likelihood of a smoker [non-smoker] dying from heart disease?," 0=impossible, 11=certain)
Measured: immediately following last exposure or after 6-week delay
smoking risk knowledge
Participants listed as many risks of smoking as they could think of.
Measured: immediately following last exposure or after 6-week delay
quit intentions
Participants intentions to quit smoking, Likelihood of smoking within next 30 days, next year (-3 = very unlikely, 3 = very likely)
Measured: immediately following last exposure or 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 start16 Apr 2016
- Primary completion2 Jun 2016
- Study completion2 Jun 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Smoking, CigaretteStudies 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
- 866 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
- NCT03501472
- Sponsor's protocol ID
- P50CA180908A2b
- Other IDs
- P50CA180908
- Status last verified
- Apr 2018
- First submitted
- 10 Apr 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, Numeracy, and Memory for Numeric Cigarette Health-risk Information Over Time
- ClinicalTrials.gov ID
- NCT03501472
- Acronym / sponsor ID
- P50CA180908A2b
- Conditions
- Smoking, Cigarette, Smoking Cessation
- Keywords
- pictorial warning labels, risk knowledge, emotion, memory, risk perceptions, quit intentions, numeracy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 866 participants (actual)
- Lead sponsor
- Ohio State UniversityUniversity, hospital or other
- Collaborators
- University of Pennsylvania
- Study start
- 16 Apr 2016 (actual)
- Primary completion
- 2 Jun 2016 (actual)
- Study completion
- 2 Jun 2016 (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, or for numeric risks (e.g., percentage risk for developing lung cancer). This trial tests memory for numeric health risks immediately or after a six-week delay for US adult smokers. In addition, the trial tests the effects of different warning label components (e.g., whether the numeric risks are percentage or frequency), participants' level of numeric ability, and the consequences of memory for numeric risks on participant risk perceptions and quit intentions.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Text-only PWL, immediate post | Experimental | Behavioral: text-only PWL, Behavioral: immed posttestExposure to 4 FDA-mandated warning labels and numeric risk information for 8 outcomes related to those warnings (2 outcomes for each PWL; half as percentage, half as frequency) Posttest measures (e.g., memory, risk perceptions, quit intentions) administered immediately following last exposure to warning labels |
| Text-only PWL, delay posttest | Experimental | Behavioral: text-only PWL, Behavioral: delay posttestExposure to 4 FDA-mandated warning labels and numeric risk information for 8 outcomes related to those warnings (2 outcomes for each PWL; half as percentage, half as frequency) Posttest measures (e.g., memory, risk perceptions, quit intentions) administered 6 weeks following last exposure to warning labels |
| Low-emot PWL, immed post | Experimental | Behavioral: low-emot PWL, Behavioral: immed posttestExposure to 4 FDA-mandated warning labels paired with images that elicit little emotion and numeric risk information for 8 outcomes related to those warnings (2 outcomes for each PWL; half as percentage, half as frequency) Posttest measures (e.g., memory, risk perceptions, quit intentions) administered immediately following last exposure to warning labels |
| Low-emot PWL, delay posttest | Experimental | Behavioral: low-emot PWL, Behavioral: delay posttestExposure to 4 FDA-mandated warning labels paired with images that elicit little emotion and numeric risk information for 8 outcomes related to those warnings (2 outcomes for each PWL; half as percentage, half as frequency) Posttest measures (e.g., memory, risk perceptions, quit intentions) administered 6 weeks following last exposure to warning labels |
| High-emot PWL, immed posttest | Experimental | Behavioral: high-emot PWL, Behavioral: immed posttestExposure to 4 FDA-mandated warning labels paired with images that elicit high emotion and numeric risk information for 8 outcomes related to those warnings (2 outcomes for each PWL; half as percentage, half as frequency) Posttest measures (e.g., memory, risk perceptions, quit intentions) administered immediately following last exposure to warning labels |
| High-emot PWL, delay posttest | Experimental | Behavioral: high-emot PWL, Behavioral: delay posttestExposure to 4 FDA-mandated warning labels paired with images that elicit high emotion and numeric risk information for 8 outcomes related to those warnings (2 outcomes for each PWL; half as percentage, half as frequency) Posttest measures (e.g., memory, risk perceptions, quit intentions) administered 6 weeks following last exposure to warning labels |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- at least 18 years old
- have smoked 100+ lifetime cigarettes
- currently smoke "every day" or "some days."
- US resident
Key exclusion criteria (1 listed)
- have not ever smoked a cigarette
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 PWL | Behavioural | Text-only PWL, delay posttest, Text-only PWL, immediate post |
| low-emot PWL | Behavioural | Low-emot PWL, delay posttest, Low-emot PWL, immed post |
| high-emot PWL | Behavioural | High-emot PWL, delay posttest, High-emot PWL, immed posttest |
| immed posttest | Behavioural | High-emot PWL, immed posttest, Low-emot PWL, immed post, Text-only PWL, immediate post |
| delay posttest | Behavioural | High-emot PWL, delay posttest, Low-emot PWL, delay posttest, Text-only PWL, delay posttest |
Primary outcome
numeric risk recall
Time frame: immediately following last exposure or after 6-week delay
free recall for numeric risks presented in labels (e.g., ____% of smokers die before age 85), both for smokers and nonsmokers
numeric risk recognition
Time frame: immediately following last exposure or after 6-week delay
Participants answered one multiple choice question about the numeric risk for smokers and nonsmokers (combined in one question) for each of the 8 outcomes that had been paired with the PWLs. For each question, there were four decoy responses.
3 secondary outcomes
smoking risk perceptions
Time frame: immediately following last exposure or after 6-week delay
smoking risk knowledge
Time frame: immediately following last exposure or after 6-week delay
quit intentions
Time frame: immediately following last exposure or 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, low-emot PWL and high-emot PWL in people with Smoking, Cigarette and Smoking Cessation, 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 4 inclusion and 1 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 recall (time frame: immediately following last exposure or after 6-week delay). The study lists 2 primary outcomes in all. 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.