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

Smoking Cessation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03375840
• Other study ID #: P50CA180908A1
• Secondary ID: P50CA180908
• Status: Completed
• Phase: Phase 3
• First received: December 8, 2017
• Last updated: December 12, 2017
• Start date: April 17, 2015
• Est. completion date: January 27, 2016

Study information

• Verified date: December 2017
• Source: Ohio State University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 4424
• Est. completion date: January 27, 2016
• Est. primary completion date: January 27, 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 14 Years to 65 Years

Eligibility

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)

Related Conditions & MeSH terms

• Smoking Cessation
• Smoking, Cigarette

Intervention

Behavioral:
• Text-only PWL
Control condition
• Low-emot PWL
Pictorial warning
• High-emot PWL
Pictorial warning
• Immediate posttest

• delay posttest

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Ohio State University	University of Pennsylvania

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	smoking risk perceptions	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
Secondary	quit intentions	participants' intentions to quit smoking	immediately following last exposure or after 6-week delay