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

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.

Study Overview

• Status: Completed
• Conditions: Smoking Cessation; Smoking, Cigarette
• Intervention / Treatment: Behavioral: Text-only PWL; Behavioral: Immediate posttest; Behavioral: delay posttest; Behavioral: Low-emot PWL; Behavioral: High-emot PWL

• Study Type: Interventional
• Enrollment (Actual): 4424
• Phase: Phase 3

Participation Criteria

Eligibility Criteria

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

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Factorial Assignment

Number of Arms

6

Arms and Interventions

Participant Group / 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: Immediate posttest; Behavioral: Low-emot PWL; Pictorial warning
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: delay posttest; Behavioral: Low-emot PWL; Pictorial warning
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: Immediate posttest; Behavioral: High-emot PWL; Pictorial warning
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: delay posttest; Behavioral: High-emot PWL; Pictorial warning

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
quit intentions	participants' intentions to quit smoking	immediately following last exposure or after 6-week delay

Collaborators and Investigators

• Sponsor: Ohio State University
• Collaborators: University of Pennsylvania

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): April 17, 2015
• Primary Completion (Actual): January 27, 2016
• Study Completion (Actual): January 27, 2016

Study Registration Dates

• First Submitted: December 8, 2017
• First Submitted That Met QC Criteria: December 12, 2017
• First Posted (Actual): December 18, 2017

Study Record Updates

• Last Update Posted (Actual): December 18, 2017
• Last Update Submitted That Met QC Criteria: December 12, 2017
• Last Verified: December 1, 2017

More Information

Terms related to this study

• Keywords: memory; emotion; pictorial warning labels; risk knowledge; risk perceptions; quit intentions
• Other Study ID Numbers: P50CA180908A1; P50CA180908 (U.S. NIH Grant/Contract)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No