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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
Health authority
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)

Study Design


Related Conditions & MeSH terms


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
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