The Impact of Cigarillo Warnings on Purchasing

The Impact of Cigarillo Warnings on Purchasing Behaviors Among Young Adult Cigarillo Users

The purpose of this study is to determine whether different cigarillo warning formats (pictorial, FDA-proposed text-only, current Surgeon General text-only) reduces demand for cigarillos. A previous study has identified that pictorial cigarillo warnings are perceived as more effective, but more information is needed on their impact. This study will address this issue by randomizing participants to see different cigarillo warning formats on cigarillo products within an online experimental tobacco marketplace. Participants will be cigarillo users who are ages 21-35.

Study Overview

• Status: Completed
• Conditions: Cigar Smoking
• Intervention / Treatment: Behavioral: Cigarillo warnings-Surgeon General Text-Only; Behavioral: Cigarillo warnings-FDA proposed text-only; Behavioral: Cigarillo warnings-Pictorial

Detailed Description

Warning labels on tobacco products convey the health risks and discourage use. Warnings are even more effective when they contain images that depict the health consequences. However, little is known about the impact of cigarillo warnings, including pictorial warnings, on consumer behavior. The Experimental Tobacco Marketplace (ETM) task examines the effects of regulations on tobacco purchasing in the context of a complex tobacco marketplace. This project aims to address the gap in the knowledge about cigarillo risk communication by providing information on best practices for cigarillo warnings. Identifying effective cigarillo warnings is important to inform policy and guide research on effectively communicating risk to ultimately decrease use and tobacco-related morbidity and mortality.

• Study Type: Interventional
• Enrollment (Actual): 1578
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Winston-Salem, North Carolina, United States, 27157
      • Wake Forest University Health Sciences

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 35 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Current cigarillo users: used cigarillos at least one time per week in the past month
• Members of the Kantar Media panel

Exclusion Criteria:

• Non-English speakers
• Non-current cigarillo users
• Not members of Kantar Media

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Cigarillo warnings-Surgeon General Text-Only; Participants will complete 6 mock shopping trips in the Experimental Tobacco Marketplace, and be asked to spend their weekly tobacco budget. Cigarillos in the Marketplace will have one of three cigarillo warnings in the Surgeon General Text-Only format.	Behavioral: Cigarillo warnings-Surgeon General Text-Only; Participants will complete 6 mock shopping trips in the Experimental Tobacco Marketplace, and be asked to spend their weekly tobacco budget. Cigarillos in the Marketplace will have one of three cigarillo warnings in the Surgeon General Text-Only format.
Experimental: Cigarillo warnings-FDA proposed text-only; Participants will complete 6 mock shopping trips in the Experimental Tobacco Marketplace, and be asked to spend their weekly tobacco budget. Cigarillos in the Marketplace will have one of three cigarillo warnings in the FDA Proposed Text-Only format.	Behavioral: Cigarillo warnings-FDA proposed text-only; Participants will complete 6 mock shopping trips in the Experimental Tobacco Marketplace, and be asked to spend their weekly tobacco budget. Cigarillos in the Marketplace will have one of three cigarillo warnings in the FDA Proposed Text-Only format.
Experimental: Cigarillo warnings-Pictorial; Participants will complete 6 mock shopping trips in the Experimental Tobacco Marketplace, and be asked to spend their weekly tobacco budget. Cigarillos in the Marketplace will have one of three cigarillo warnings in the Pictorial format.	Behavioral: Cigarillo warnings-Pictorial; Participants will complete 6 mock shopping trips in the Experimental Tobacco Marketplace, and be asked to spend their weekly tobacco budget. Cigarillos in the Marketplace will have one of three cigarillo warnings in the Pictorial format.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Average Total Number of Cigarillos Purchased	Participants in each arm will participate in six mock shopping trips with a specified budget. They will purchase (mock) single cigarillos. The primary outcome is the average number of cigarillos purchased during each of the six mock shopping trips.	Within the 20-minute survey

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Average Total Amount of mg Combusted Tobacco Purchased	Participants will participate in six mock shopping trips with a specified budget. They will have the option to purchase (mock) tobacco products in addition to cigarillos: cigarettes, menthol cigarettes, e-cigarettes/vaping devices, oral nicotine. This outcome will be the sum mg of the number of combusted non-cigarillo tobacco products purchased during each of the six mock shopping trips	Within the 20-minute survey
Average Total Amount of mg Non-combusted Tobacco Purchased	Participants will participate in six mock shopping trips with a specified budget. They will have the option to purchase (mock) tobacco products in addition to cigarillos: cigarettes, menthol cigarettes, e-cigarettes/vaping devices, oral nicotine. This outcome will be the sum mg of the number of non-combusted tobacco products purchased during each of the six mock shopping trips.	Within the 20-minute survey
Intensity Index for Cigarillos	Number of cigarillos purchased at lowest price, averaged across the six shopping trips	Within the 20 minute survey.
Cost Related Indices for Cigarillos	Omax is the maximum amount spent on cigarillos across all shopping trips. Breakpoint is the price where no cigarillos were purchased. Pmax is the price where Omax occurs.	Within the 20-minute survey
Rate of Change for Cigarillo Demand	The rate of change for cigarillo demand is called Alpha, which is the rate constant of fitted Exponentiated Demand Equation. It is calculated with the Exponentiated Demand Equation, Q=Q0*10^k(e-αQ0C -1), where Q is the mg of nicotine purchased at a given price, Q0 is peak demand consumption or intensity (typically occurring at the lowest price), k is a constant across all compared conditions, and alpha (α) is the rate of change in demand or elasticity.	Within the 20-minute survey

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean Perceived Message Effectiveness	The 3-item UNC mean perceived message effectiveness scale assesses a participant's judgement of a warning's impact on their cigarillo beliefs and behavior. Response options are on a 1 to 5 scale. Overall scores are determined by summing the scores of the 3 items and dividing by 3 (range 1-5), with higher scores representing a higher amount of the construct	Within the 20-minute survey
Self-Reported Learning	One survey item asking participants to what extent did they learn something new from the warning. Response options are on a 1 to 5 scale, with the higher number indicating more self-reported learning.	Within the 20-minute survey
Negative Affect	Three survey items to measure emotional reactions (anxious, scared, disgusted) to the cigarillo warning the participant saw. Response options are on a 1 to 5 scale. Overall scale scores are determined by summing scores of the 4 items and dividing by 4 (range 1-5), with higher scores representing a higher amount of the construct.	Within the 20-minute survey
Cognitive Elaboration	The 1 item measure assesses the extent to which a participant reports the warning making them think about the risks of cigarillo smoking. Response options are on a 1 to 5 scale, with higher scores representing a higher amount of the construct.	Within the 20-minute survey
Intentions to Quit Using Cigarillos	Three survey items to measure participant's interest in quitting cigarillo smoking in the next month, likelihood of quitting smoking cigarillos in the month week, and plans to quit smoking cigarillos in the next month. Response options are on a 1 to 5 scale. Overall scale scores are determined by summing the scores of the 3 items and dividing by 3 (range 1-5), with higher scores representing a higher amount of the construct/intentions to quit	Within the 20-minute survey
Warning Recall	one survey item asking participants if they noticed any health warnings on the cigarillo packages during their shopping tasks, with response options of Yes, No, and I'm not sure. Recall will be determine if participants select Yes.	Within the 20-minute survey
Warning Recognition	One survey item asking participants to identify which warning they saw during their mock shopping trips. Participants will be shown their warning, a warning that wasn't in their ETM, and "I don't know" response options. Selecting the correct warning indicates warning recognition.	Within the 20-minute survey
Average Total Amount of Non-tobacco Products Purchased	Participants will participate in six mock shopping trips with a specified budget. They will have the option to purchase (mock) tobacco products in addition to cigarillos: cigarettes, menthol cigarettes, e-cigarettes/vaping devices, oral nicotine, and two non-tobacco options: snack food and non-alcoholic beverage. This outcome will be the sum mg of the number of non- tobacco products purchased during each of the six mock shopping trips.	Within the 20-minute survey

Collaborators and Investigators

• Sponsor: Boston University
• Collaborators: National Cancer Institute (NCI); Brown University; National Institutes of Health (NIH); Wake Forest University Health Sciences; Food and Drug Administration (FDA)
• Investigators: Principal Investigator: Jennifer C Ross, PhD, BU School of Public Health

Study record dates

Study Major Dates

• Study Start (Actual): June 24, 2022
• Primary Completion (Actual): July 21, 2022
• Study Completion (Actual): July 21, 2022

Study Registration Dates

• First Submitted: June 22, 2022
• First Submitted That Met QC Criteria: June 22, 2022
• First Posted (Actual): June 27, 2022

Study Record Updates

• Last Update Posted (Actual): August 2, 2023
• Last Update Submitted That Met QC Criteria: August 1, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Keywords: Cigarillo smoking; Cigarillo packaging warnings
• Other Study ID Numbers: NE-1; R01CA260460 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Deidentified individual data may be provided to qualified investigators starting 9 months and ending 36 months after publication. Investigators proposing to use the data must receive a data use agree with Wake Forest University Health Sciences and seek approval from an Institutional Review Board (IRB), or similar body identified for this purpose.
• IPD Sharing Time Frame: 9-36 months following publication
• IPD Sharing Access Criteria: Qualified researchers engaged in independent scientific research with IRB approval and a data use agreement with Wake Forest University Health Sciences.
• IPD Sharing Supporting Information Type: SAP; ICF

Drug and device information, study documents

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