NCT03499340

Brief 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. In this study, adult smokers are repeatedly exposed to text-only vs. low arousal graphic vs. high arousal graphic warning labels paired with numeric risk information. This study will allow the investigators to assess the extent to which reactions to warnings remain consistent over time and influence smoking risk perceptions and quit intentions. The investigators will also assess the impact of graphic images on memory for smoking risk information presented in absolute (a smoker's lifetime risk of getting a smoking related disease) versus relative (a smoker's risk of getting a smoking related disease, compared to the risk of non-smokers) formats.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
3,213

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jul 2017

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 10, 2017

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 3, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 3, 2017

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

April 9, 2018

Completed
8 days until next milestone

First Posted

Study publicly available on registry

April 17, 2018

Completed
Last Updated

April 17, 2018

Status Verified

April 1, 2018

Enrollment Period

3 months

First QC Date

April 9, 2018

Last Update Submit

April 13, 2018

Conditions

Keywords

pictorial warning labelsrisk knowledgeemotionmemoryrisk perceptionsquit intentions

Outcome Measures

Primary Outcomes (1)

  • numeric risk recognition

    Participants answered one multiple choice question about the numeric risk for smokers for each label (e.g., \_\_\_\_% of smokers die before age 85). For each question, there were four decoy responses.

    measured immediately following last exposure

Secondary Outcomes (13)

  • numeric risk recognition

    measured after 6-week delay

  • relative risk recognition

    measured immediately following last exposure

  • relative risk recognition

    measured after 6-week delay

  • smoking risk perceptions

    measured immediately following last exposure

  • smoking risk perceptions

    measured after 6-week delay

  • +8 more secondary outcomes

Study Arms (6)

Text-only PWL, absolute risk

EXPERIMENTAL

Exposure to FDA-mandated warning labels, without a graphic image, accompanied by risk information about smoker's risk of a smoking-related disease

Behavioral: text-only PWLBehavioral: absolute risk

Text-only PWL, relative risk

EXPERIMENTAL

Exposure to FDA-mandated warning labels, without a graphic image, accompanied by risk information about smoker's risk and non-smoker's risk of a smoking-related disease

Behavioral: text-only PWLBehavioral: relative risk

Low arousal graphic PWL, absolute risk

EXPERIMENTAL

Exposure to FDA-mandated warning labels, paired with a low arousal graphic image, accompanied by risk information about smoker's risk of a smoking-related disease

Behavioral: low arousal graphic PWLBehavioral: absolute risk

Low arousal graphic PWL, relative risk

EXPERIMENTAL

Exposure to FDA-mandated warning labels, paired with a low arousal graphic image, accompanied by risk information about smoker's risk and non-smoker's risk of a smoking-related disease

Behavioral: low arousal graphic PWLBehavioral: relative risk

High arousal graphic PWL, absolute risk

EXPERIMENTAL

Exposure to FDA-mandated warning labels, paired with a high arousal graphic image, accompanied by risk information about smoker's risk of a smoking-related disease

Behavioral: high arousal graphic PWLBehavioral: absolute risk

High arousal graphic PWL, relative risk

EXPERIMENTAL

Exposure to FDA-mandated warning labels, paired with a high arousal graphic image, accompanied by risk information about smoker's risk and non-smoker's risk of a smoking-related disease

Behavioral: high arousal graphic PWLBehavioral: relative risk

Interventions

text-only PWLBEHAVIORAL

control condition (no image)

Text-only PWL, absolute riskText-only PWL, relative risk

pictorial warning

Low arousal graphic PWL, absolute riskLow arousal graphic PWL, relative risk

pictorial warning

High arousal graphic PWL, absolute riskHigh arousal graphic PWL, relative risk
absolute riskBEHAVIORAL

Percentage risk information for smoking-related diseases for smokers

High arousal graphic PWL, absolute riskLow arousal graphic PWL, absolute riskText-only PWL, absolute risk
relative riskBEHAVIORAL

Percentage risk information for smoking-related diseases for smokers and non-smokers

High arousal graphic PWL, relative riskLow arousal graphic PWL, relative riskText-only PWL, relative risk

Eligibility Criteria

Age19 Years - 64 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • have smoked 100+ lifetime cigarettes
  • currently smoke "every day" or "some days."

You may not qualify if:

  • have not ever smoked a cigarette

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Ohio State University

Columbus, Ohio, 43210, United States

Location

MeSH Terms

Conditions

Smoking CessationCigarette Smoking

Interventions

Numbers Needed To TreatRisk

Condition Hierarchy (Ancestors)

Health BehaviorBehaviorTobacco SmokingSmokingTobacco Use

Intervention Hierarchy (Ancestors)

Sample SizeResearch DesignMethodsInvestigative TechniquesProbabilityStatistics as TopicEpidemiologic MethodsMathematical ConceptsHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

April 9, 2018

First Posted

April 17, 2018

Study Start

July 10, 2017

Primary Completion

October 3, 2017

Study Completion

October 3, 2017

Last Updated

April 17, 2018

Record last verified: 2018-04

Locations