Smoking CessationPhase 3NCT03375840
Pictorial Warning Labels and Memory for Cigarette Health-risk Information Over Time
A Phase 3 study testing Text-only PWL, Low-emot PWL and High-emot PWL 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. Read more about this study
- Who is it for?
- Ages 14 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Smoking Cessation, Smoking, Cigarette
- 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
- 4,424 participants
- Where
- No sites listed yet
- Study dates
- 17 Apr 2015to 27 Jan 2016
- Phase
- Phase 3
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 19-65 years old (adult samples)
- have smoked 100+ lifetime cigarettes (adult samples)
- currently smoke "every day" or "some days." (adult samples)
- 14-18 years old (teen sample)
- have ever smoked a cigarette (teen sample)
Who cannot join
- have not ever smoked a cigarette (all samples)
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. This trial tests memory for health risks immediately or after a six-week delay for US-representative adult smokers, US-representative teen smokers/vulnerable smokers, and Appalachian-representative adult smokers. In addition, the trial tests the effects of different warning label components and the consequences of memory for labels on risk perceptions and quit intentions.
- Conditions
- Smoking Cessation, Smoking, Cigarette
- Being tested
- Text-only PWL, Low-emot PWL, High-emot PWL, Immediate posttest, delay posttest
- 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
Low-emot PWLBehavioural
Pictorial warning
High-emot PWLBehavioural
Pictorial warning
Immediate posttestBehavioural
delay posttestBehavioural
| Study group | Role | What they receive |
|---|---|---|
| Text-only PWL, immediate post | Experimental | Exposure to 9 FDA-mandated warning labels
Posttest measures (e.g., memory, risk perceptions, quit intentions) administered immediately following last exposure to warning labels Receives: Behavioral: Text-only PWL; Behavioral: Immediate posttest |
| Text-only PWL, delay posttest | Experimental | Exposure to 9 FDA-mandated warning labels
Posttest measures (e.g., memory, risk perceptions, quit intentions) administered 6 weeks after last exposure to warning labels Receives: Behavioral: Text-only PWL; Behavioral: delay posttest |
| Low-emot PWL, immediate posttest | Experimental | Exposure to 9 warning labels paired with image that elicited little emotion
Posttest measures (e.g., memory, risk perceptions, quit intentions) administered immediately following last exposure to warning labels Receives: Behavioral: Low-emot PWL; Behavioral: Immediate posttest |
| Low-emot PWL, delay posttest | Experimental | Exposure to 9 warning labels paired with image that elicited little emotion
Posttest measures (e.g., memory, risk perceptions, quit intentions) administered 6 weeks after last exposure to warning labels Receives: Behavioral: Low-emot PWL; Behavioral: delay posttest |
| High-emot PWL, immediate posttest | Experimental | Exposure to 9 warning labels paired with image that elicited high emotion
Posttest measures (e.g., memory, risk perceptions, quit intentions) administered immediately following last exposure to warning labels Receives: Behavioral: High-emot PWL; Behavioral: Immediate posttest |
| High-emot PWL, delay posttest | Experimental | Exposure to 9 warning labels paired with image that elicited high emotion
Posttest measures (e.g., memory, risk perceptions, quit intentions) administered 6 weeks after 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.
graphic warning label recall
free recall for risk information presented in labels (9 text boxes, 1 for each label; coded for exact or equivalent words)
Measured: immediately following last exposure or after 6-week delay
smoking risk recognition
Participants were subsequently shown twenty-six negative health effects and asked "Which of the following health effects were mentioned in the warnings we showed you?" and responded "Yes, I saw this health effect" or "No, I did not see this health effect." Fourteen risks were mentioned in the warnings (e.g., cancer, harms children, emphysema); six were risks of smoking not presented in the warnings (e.g., wrinkles, diabetes), and six were not risks of smoking (e.g., acne, thyroid problems).
Measured: immediately following last exposure or after 6-week delay
Secondary outcomes (2)
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))
Measured: immediately following last exposure or after 6-week delay
quit intentions
participants' intentions to quit smoking
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 Dec 2017
- Study start17 Apr 2015
- Primary completion27 Jan 2016
- Study completion27 Jan 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Enrolment
- 4,424 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
- NCT03375840
- Sponsor's protocol ID
- P50CA180908A1
- Other IDs
- P50CA180908
- Status last verified
- Dec 2017
- First submitted
- 8 Dec 2017
- Last updated
- 18 Dec 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Peters E, Shoots-Reinhard B, Evans AT, Shoben A, Klein E, Tompkins MK, Romer D, Tusler M. Pictorial Warning Labels and Memory for Cigarette Health-risk Information Over Time. Ann Behav Med. 2019 Mar 20;53(4):358-371. doi: 10.1093/abm/kay050.
PubMed 29947729
Study at a glance
From the registry record, last updated by the sponsor on 18 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pictorial Warning Labels and Memory for Cigarette Health-risk Information Over Time
- ClinicalTrials.gov ID
- NCT03375840
- Acronym / sponsor ID
- P50CA180908A1
- Conditions
- Smoking Cessation, Smoking, Cigarette
- Keywords
- pictorial warning labels, risk knowledge, emotion, memory, risk perceptions, quit intentions
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 4,424 participants (actual)
- Lead sponsor
- Ohio State UniversityUniversity, hospital or other
- Collaborators
- University of Pennsylvania
- Study start
- 17 Apr 2015 (actual)
- Primary completion
- 27 Jan 2016 (actual)
- Study completion
- 27 Jan 2016 (actual)
- First posted
- 18 Dec 2017 (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. This trial tests memory for health risks immediately or after a six-week delay for US-representative adult smokers, US-representative teen smokers/vulnerable smokers, and Appalachian-representative adult smokers. In addition, the trial tests the effects of different warning label components and the consequences of memory for labels on risk perceptions and quit intentions.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Text-only PWL, immediate post | Experimental | Behavioral: Text-only PWL, Behavioral: Immediate posttestExposure to 9 FDA-mandated warning labels 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 9 FDA-mandated warning labels Posttest measures (e.g., memory, risk perceptions, quit intentions) administered 6 weeks after last exposure to warning labels |
| Low-emot PWL, immediate posttest | Experimental | Behavioral: Low-emot PWL, Behavioral: Immediate posttestExposure to 9 warning labels paired with image that elicited little emotion 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 9 warning labels paired with image that elicited little emotion Posttest measures (e.g., memory, risk perceptions, quit intentions) administered 6 weeks after last exposure to warning labels |
| High-emot PWL, immediate posttest | Experimental | Behavioral: High-emot PWL, Behavioral: Immediate posttestExposure to 9 warning labels paired with image that elicited high emotion 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 9 warning labels paired with image that elicited high emotion Posttest measures (e.g., memory, risk perceptions, quit intentions) administered 6 weeks after last exposure to warning labels |
Who may qualify
- Ages
- 14 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- 19-65 years old (adult samples)
- have smoked 100+ lifetime cigarettes (adult samples)
- currently smoke "every day" or "some days." (adult samples)
- 14-18 years old (teen sample)
- have ever smoked a cigarette (teen sample)
Key exclusion criteria (1 listed)
- have not ever smoked a cigarette (all samples)
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 | Behavioural | Text-only PWL, delay posttest, Text-only PWL, immediate post |
| Low-emot PWLPictorial warning | Behavioural | Low-emot PWL, delay posttest, Low-emot PWL, immediate posttest |
| High-emot PWLPictorial warning | Behavioural | High-emot PWL, delay posttest, High-emot PWL, immediate posttest |
| Immediate posttest | Behavioural | High-emot PWL, immediate posttest, Low-emot PWL, immediate posttest, 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
graphic warning label recall
Time frame: immediately following last exposure or after 6-week delay
free recall for risk information presented in labels (9 text boxes, 1 for each label; coded for exact or equivalent words)
smoking risk recognition
Time frame: immediately following last exposure or after 6-week delay
Participants were subsequently shown twenty-six negative health effects and asked "Which of the following health effects were mentioned in the warnings we showed you?" and responded "Yes, I saw this health effect" or "No, I did not see this health effect." Fourteen risks were mentioned in the warnings (e.g., cancer, harms children, emphysema); six were risks of smoking not presented in the warnings (e.g., wrinkles, diabetes), and six were not risks of smoking (e.g., acne, thyroid problems).
2 secondary outcomes
smoking risk perceptions
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 Dec 2017.
- Derived from this study: PubMed 29947729Peters E, Shoots-Reinhard B, Evans AT, Shoben A, Klein E, Tompkins MK, Romer D, Tusler M. Pictorial Warning Labels and Memory for Cigarette Health-risk Information Over Time. Ann Behav Med. 2019 Mar 20;53(4):358-371. doi: 10.1093/abm/kay050.
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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 Phase 3 study testing Text-only PWL, Low-emot PWL and High-emot PWL 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 5 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 Dec 2017. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
graphic warning label 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?
On the ClinicalTrials.gov record for NCT03375840, which also lists 1 linked publication.
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 Dec 2017.