NCT03500965

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, teens who have experimented with smoking or are considered vulnerable to smoking are repeatedly exposed to text-only vs. graphic warning labels paired with numeric risk information. This study will allow us to assess the extent to which reactions to warnings remain consistent over time and influence future smoking intentions. We will also assess the impact of graphic images on memory for smoking risk information presented in absolute and (a smokers lifetime risk of getting a smoking related disease), or relative (a smokers risk of getting a smoking related disease, compared to the risk of non-smokers) formats.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
422

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started May 2016

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

May 25, 2016

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 9, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 9, 2018

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

February 14, 2018

Completed
2 months until next milestone

First Posted

Study publicly available on registry

April 18, 2018

Completed
Last Updated

April 18, 2018

Status Verified

April 1, 2018

Enrollment Period

1.6 years

First QC Date

February 14, 2018

Last Update Submit

April 9, 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 (4)

Text-only PWL, absol 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

graphic PWL, absol risk

EXPERIMENTAL

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

Behavioral: graphic PWLBehavioral: absolute risk

graphic PWL, relative risk

EXPERIMENTAL

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

Behavioral: graphic PWLBehavioral: relative risk

Interventions

text-only PWLBEHAVIORAL

control condition (no image)

Text-only PWL, absol risktext-only PWL, relative risk
graphic PWLBEHAVIORAL

pictorial warning

graphic PWL, absol riskgraphic PWL, relative risk
absolute riskBEHAVIORAL

Percentage risk information for smoking-related diseases for smokers

Text-only PWL, absol riskgraphic PWL, absol risk
relative riskBEHAVIORAL

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

graphic PWL, relative risktext-only PWL, relative risk

Eligibility Criteria

Age14 Years - 18 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • have ever tried smoking
  • report vulnerability to smoking (i.e., report that they might smoke in the next year or would try a cigarette if a friend offered one)
  • parents give permission to participate

You may not qualify if:

  • not vulnerable to smoking (i.e., report they will definitely not smoke a cigarette in the next year and definitely would not try a cigarette if one was offered
  • parents do not provide permission to participate

Contact the study team to confirm eligibility.

Sponsors & Collaborators

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

February 14, 2018

First Posted

April 18, 2018

Study Start

May 25, 2016

Primary Completion

January 9, 2018

Study Completion

January 9, 2018

Last Updated

April 18, 2018

Record last verified: 2018-04