NCT03501472

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, 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.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
866

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 2016

Shorter than P25 for not_applicable

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

April 16, 2016

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 2, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 2, 2016

Completed
1.9 years until next milestone

First Submitted

Initial submission to the registry

April 10, 2018

Completed
8 days 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

2 months

First QC Date

April 10, 2018

Last Update Submit

April 10, 2018

Conditions

Keywords

pictorial warning labelsrisk knowledgeemotionmemoryrisk perceptionsquit intentionsnumeracy

Outcome Measures

Primary Outcomes (2)

  • numeric risk recall

    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

    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 Outcomes (3)

  • smoking risk perceptions

    immediately following last exposure or after 6-week delay

  • smoking risk knowledge

    immediately following last exposure or after 6-week delay

  • quit intentions

    immediately following last exposure or after 6-week delay

Study Arms (6)

Text-only PWL, immediate post

EXPERIMENTAL

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 PWLBehavioral: immed posttest

Text-only PWL, delay posttest

EXPERIMENTAL

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 PWLBehavioral: delay posttest

Low-emot PWL, immed post

EXPERIMENTAL

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 PWLBehavioral: immed posttest

Low-emot PWL, delay posttest

EXPERIMENTAL

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 PWLBehavioral: delay posttest

High-emot PWL, immed posttest

EXPERIMENTAL

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 PWLBehavioral: immed posttest

High-emot PWL, delay posttest

EXPERIMENTAL

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 PWLBehavioral: delay posttest

Interventions

text-only PWLBEHAVIORAL
Text-only PWL, delay posttestText-only PWL, immediate post
low-emot PWLBEHAVIORAL
Low-emot PWL, delay posttestLow-emot PWL, immed post
high-emot PWLBEHAVIORAL
High-emot PWL, delay posttestHigh-emot PWL, immed posttest
immed posttestBEHAVIORAL
High-emot PWL, immed posttestLow-emot PWL, immed postText-only PWL, immediate post
delay posttestBEHAVIORAL
High-emot PWL, delay posttestLow-emot PWL, delay posttestText-only PWL, delay posttest

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • have not ever smoked a cigarette

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Cigarette SmokingSmoking Cessation

Condition Hierarchy (Ancestors)

Tobacco SmokingSmokingBehaviorTobacco UseHealth Behavior

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 10, 2018

First Posted

April 18, 2018

Study Start

April 16, 2016

Primary Completion

June 2, 2016

Study Completion

June 2, 2016

Last Updated

April 18, 2018

Record last verified: 2018-04