NCT03375840

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. 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.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
4,424

participants targeted

Target at P75+ for phase_3

Timeline
Completed

Started Apr 2015

Shorter than P25 for phase_3

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 17, 2015

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 27, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 27, 2016

Completed
1.9 years until next milestone

First Submitted

Initial submission to the registry

December 8, 2017

Completed
10 days until next milestone

First Posted

Study publicly available on registry

December 18, 2017

Completed
Last Updated

December 18, 2017

Status Verified

December 1, 2017

Enrollment Period

10 months

First QC Date

December 8, 2017

Last Update Submit

December 12, 2017

Conditions

Keywords

pictorial warning labelsrisk knowledgeemotionmemoryrisk perceptionsquit intentions

Outcome Measures

Primary Outcomes (2)

  • graphic warning label recall

    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

    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 Outcomes (2)

  • smoking risk perceptions

    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 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 PWLBehavioral: Immediate posttest

Text-only PWL, delay posttest

EXPERIMENTAL

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 PWLBehavioral: delay posttest

Low-emot PWL, immediate posttest

EXPERIMENTAL

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: Low-emot PWLBehavioral: Immediate posttest

Low-emot PWL, delay posttest

EXPERIMENTAL

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: Low-emot PWLBehavioral: delay posttest

High-emot PWL, immediate posttest

EXPERIMENTAL

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: High-emot PWLBehavioral: Immediate posttest

High-emot PWL, delay posttest

EXPERIMENTAL

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: High-emot PWLBehavioral: delay posttest

Interventions

Text-only PWLBEHAVIORAL

Control condition

Text-only PWL, delay posttestText-only PWL, immediate post
Low-emot PWLBEHAVIORAL

Pictorial warning

Low-emot PWL, delay posttestLow-emot PWL, immediate posttest
High-emot PWLBEHAVIORAL

Pictorial warning

High-emot PWL, delay posttestHigh-emot PWL, immediate posttest
High-emot PWL, immediate posttestLow-emot PWL, immediate posttestText-only PWL, immediate post
delay posttestBEHAVIORAL
High-emot PWL, delay posttestLow-emot PWL, delay posttestText-only PWL, delay posttest

Eligibility Criteria

Age14 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • years old (adult samples)
  • have smoked 100+ lifetime cigarettes (adult samples)
  • currently smoke "every day" or "some days." (adult samples)
  • years old (teen sample)
  • have ever smoked a cigarette (teen sample)

You may not qualify if:

  • have not ever smoked a cigarette (all samples)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Peters E, Shoots-Reinhard B, Evans AT, Shoben A, Klein E, Tompkins MK, Romer D, Tusler M. Pictorial Warning Labels and Memory for Cigarette Health-risk Information Over Time. Ann Behav Med. 2019 Mar 20;53(4):358-371. doi: 10.1093/abm/kay050.

MeSH Terms

Conditions

Smoking CessationCigarette Smoking

Condition Hierarchy (Ancestors)

Health BehaviorBehaviorTobacco SmokingSmokingTobacco Use

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Purpose
PREVENTION
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

December 8, 2017

First Posted

December 18, 2017

Study Start

April 17, 2015

Primary Completion

January 27, 2016

Study Completion

January 27, 2016

Last Updated

December 18, 2017

Record last verified: 2017-12