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

April 10, 2018 updated by: Ellen Peters, Ohio State University
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 Overview

Study Type

Interventional

Enrollment (Actual)

866

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • have not ever smoked a cigarette

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Factorial Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

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

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

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

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

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
immediately following last exposure or after 6-week delay
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.
immediately following last exposure or after 6-week delay

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
smoking risk perceptions
Time Frame: immediately following last exposure or after 6-week delay

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)

immediately following last exposure or after 6-week delay
smoking risk knowledge
Time Frame: immediately following last exposure or after 6-week delay
Participants listed as many risks of smoking as they could think of.
immediately following last exposure or after 6-week delay
quit intentions
Time Frame: immediately following last exposure or after 6-week delay
Participants intentions to quit smoking, Likelihood of smoking within next 30 days, next year (-3 = very unlikely, 3 = very likely)
immediately following last exposure or after 6-week delay

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 16, 2016

Primary Completion (Actual)

June 2, 2016

Study Completion (Actual)

June 2, 2016

Study Registration Dates

First Submitted

April 10, 2018

First Submitted That Met QC Criteria

April 10, 2018

First Posted (Actual)

April 18, 2018

Study Record Updates

Last Update Posted (Actual)

April 18, 2018

Last Update Submitted That Met QC Criteria

April 10, 2018

Last Verified

April 1, 2018

More Information

Terms related to this study

Other Study ID Numbers

  • P50CA180908A2b
  • P50CA180908 (U.S. NIH Grant/Contract)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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