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

December 12, 2017 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. 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 Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
4424

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

14 years to 65 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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)

Exclusion Criteria:

• have not ever smoked a cigarette (all samples)

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Text-only PWL, immediate post

Exposure to 9 FDA-mandated warning labels

Posttest measures (e.g., memory, risk perceptions, quit intentions) administered immediately following last exposure to warning labels
Behavioral: Text-only PWL
Control condition
Behavioral: Immediate posttest
Experimental: Text-only PWL, delay posttest

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
Behavioral: Text-only PWL
Control condition
Behavioral: delay posttest
Experimental: Low-emot PWL, immediate posttest

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
Behavioral: Immediate posttest
Behavioral: Low-emot PWL
Pictorial warning
Experimental: Low-emot PWL, delay posttest

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
Behavioral: delay posttest
Behavioral: Low-emot PWL
Pictorial warning
Experimental: High-emot PWL, immediate posttest

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
Behavioral: Immediate posttest
Behavioral: High-emot PWL
Pictorial warning
Experimental: High-emot PWL, delay posttest

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
Behavioral: delay posttest
Behavioral: High-emot PWL
Pictorial warning

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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)
immediately following last exposure or after 6-week delay
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).
immediately following last exposure or after 6-week delay

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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))
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
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.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Ohio State University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
University of Pennsylvania

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 17, 2015

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 27, 2016

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 27, 2016

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 8, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 12, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 18, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 18, 2017

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 12, 2017

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2017

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • P50CA180908A1
  • 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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