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CompletedNCT03501472Updated Apr 18, 2018

Pictorial Warning Labels, Numeracy, and Memory for Numeric Cigarette Health-risk Information Over Time

An interventional study of text-only PWL and low-emot PWL in Smoking, Cigarette and Smoking Cessation, sponsored by Ohio State University. Completed. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-04-18.

Sponsored by Ohio State University · Not applicable, Interventional, and Prevention

From the registry’s dates

  • Registered 1 year 11 months after the study started (first participant enrolled Apr 2016, registered Apr 2018).
Phase
Not applicable
Study type
Interventional
Enrollment
866
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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). 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.

02

Conditions studied

  • Smoking, Cigarette
  • Smoking Cessation

Keywords

  • pictorial warning labels
  • risk knowledge
  • emotion
  • memory
  • risk perceptions
  • quit intentions
  • numeracy
03

In context

Lead sponsor

Ohio State University is the lead sponsor of 640 studies on the registry; 144 are open to participants now.

Of its 60 completed or terminated interventional studies of FDA-regulated products, 45 (75%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • at least 18 years old
  • have smoked 100+ lifetime cigarettes
  • currently smoke "every day" or "some days."
  • US resident

Exclusion criteria

Exclusion Criteria:

  • have not ever smoked a cigarette
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Factorial assignment
Masking
Double (Participant, Outcomes assessor)
Enrollment
866 participants (actual)

Study arms

  • Experimental
    Text-only PWL, immediate post

    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

    Behavioral: text-only PWL · Behavioral: immed posttest

  • Experimental
    Text-only PWL, delay posttest

    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

    Behavioral: text-only PWL · Behavioral: delay posttest

  • Experimental
    Low-emot PWL, immed post

    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

    Behavioral: low-emot PWL · Behavioral: immed posttest

  • Experimental
    Low-emot PWL, delay posttest

    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

    Behavioral: low-emot PWL · Behavioral: delay posttest

  • Experimental
    High-emot PWL, immed posttest

    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

    Behavioral: high-emot PWL · Behavioral: immed posttest

  • Experimental
    High-emot PWL, delay posttest

    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

    Behavioral: high-emot PWL · Behavioral: delay posttest

Interventions

  • Behavioraltext-only PWL
  • Behaviorallow-emot PWL
  • Behavioralhigh-emot PWL
  • Behavioralimmed posttest
  • Behavioraldelay posttest
06

What researchers measure

Primary outcomes

  1. numeric risk recall

    free recall for numeric risks presented in labels (e.g., ____% of smokers die before age 85), both for smokers and nonsmokers

    Time frame: immediately following last exposure or after 6-week delay

  2. 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.

    Time frame: immediately following last exposure or after 6-week delay

Secondary outcomes

  1. 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)

    Time frame: immediately following last exposure or after 6-week delay

  2. smoking risk knowledge

    Participants listed as many risks of smoking as they could think of.

    Time frame: immediately following last exposure or after 6-week delay

  3. quit intentions

    Participants intentions to quit smoking, Likelihood of smoking within next 30 days, next year (-3 = very unlikely, 3 = very likely)

    Time frame: immediately following last exposure or after 6-week delay

07

Study locations

No study locations are listed for this record.

08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 18, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT03501472
Lead sponsor
Ohio State University
Collaborators
University of Pennsylvania
Responsible party
Ellen Peters (Professor, Ohio State University) — Principal investigator
First posted
Apr 18, 2018
Start date
Apr 16, 2016
Primary completion
Jun 2, 2016
Completion
Jun 2, 2016
Last update
Apr 18, 2018

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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