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

• ClinicalTrials.gov Identifier: NCT03375840
• Recruitment Status: Completed
• First Posted: December 18, 2017
• Last Update Posted: December 18, 2017
• Sponsor: Ohio State University
• Collaborator: University of Pennsylvania
• Information provided by (Responsible Party): Ellen Peters, Ohio State University

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Smoking Cessation; Smoking, Cigarette	Behavioral: Text-only PWL; Behavioral: Low-emot PWL; Behavioral: High-emot PWL; Behavioral: Immediate posttest; Behavioral: delay posttest	Phase 3

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 4424 participants
• Allocation: Randomized
• Intervention Model: Factorial Assignment
• Primary Purpose: Prevention
• Official Title: Pictorial Warning Labels and Memory for Cigarette Health-risk Information Over Time
• Actual Study Start Date: April 17, 2015
• Actual Primary Completion Date: January 27, 2016
• Actual Study Completion Date: January 27, 2016

Arms and Interventions

Arm	Intervention/treatment
Experimental: Text-only PWL, immediate post; 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 PWL; Control condition; Behavioral: Immediate posttest
Experimental: Text-only PWL, delay posttest; 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 PWL; Control condition; Behavioral: delay posttest
Experimental: Low-emot PWL, immediate posttest; 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 PWL; Pictorial warning; Behavioral: Immediate posttest
Experimental: Low-emot PWL, delay posttest; 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 PWL; Pictorial warning; Behavioral: delay posttest
Experimental: High-emot PWL, immediate posttest; 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 PWL; Pictorial warning; Behavioral: Immediate posttest
Experimental: High-emot PWL, delay posttest; 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 PWL; Pictorial warning; Behavioral: delay posttest

Outcome Measures

Primary Outcome Measures :

1. graphic warning label recall [ Time Frame: immediately following last exposure or after 6-week delay ]
   free recall for risk information presented in labels (9 text boxes, 1 for each label; coded for exact or equivalent words)
2. smoking risk recognition [ Time Frame: immediately following last exposure or after 6-week delay ]
   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).

Secondary Outcome Measures :

1. smoking risk perceptions [ Time Frame: immediately following last exposure or after 6-week delay ]
   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))
2. quit intentions [ Time Frame: immediately following last exposure or after 6-week delay ]
   participants' intentions to quit smoking

Eligibility Criteria

• Ages Eligible for Study: 14 Years to 65 Years (Child, Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Criteria

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)

Contacts and Locations

No Contacts or Locations Provided

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

• Responsible Party: Ellen Peters, Professor, Ohio State University
• ClinicalTrials.gov Identifier: NCT03375840
• Other Study ID Numbers: P50CA180908A1; P50CA180908 ( U.S. NIH Grant/Contract )
• First Posted: December 18, 2017
• Last Update Posted: December 18, 2017
• Last Verified: December 2017

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Ellen Peters, Ohio State University:

pictorial warning labels; risk knowledge; emotion; memory; risk perceptions; quit intentions