Cigar Smoking
Conditions
Keywords
Cigarillo smoking, Cigarillo packaging warnings
Brief summary
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.
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.
Interventions
BEHAVIORALCigarillo 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.
BEHAVIORALCigarillo 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.
BEHAVIORALCigarillo 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.
Sponsors
Brown University
National Institutes of Health (NIH)
Food and Drug Administration (FDA)
National Cancer Institute (NCI)
Wake Forest University Health Sciences
Boston University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Subject)
Masking description
Participants will be randomly assigned to one of 3 conditions. In each of these conditions participants will see one of the following warning label formats on the cigarillos when they are shopping for tobacco products: a pictorial warning, a text-based warning, or a surgeon general warning. Participants don't know which condition they're assigned to.
Intervention model description
The study will conduct a three-group, between-subjects experiment to compare varying cigarillo warning formats: Surgeon General text-only, FDA-proposed text-only, and study developed pictorial cigarillo warning labels.
Eligibility
Sex/Gender
ALL
Age
21 Years to 35 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Average Total Number of Cigarillos Purchased | Within the 20-minute survey | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Average Total Amount of mg Combusted Tobacco Purchased | Within the 20-minute survey | 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 |
| Average Total Amount of mg Non-combusted Tobacco Purchased | Within the 20-minute survey | 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. |
| Intensity Index for Cigarillos | Within the 20 minute survey. | Number of cigarillos purchased at lowest price, averaged across the six shopping trips |
| Cost Related Indices for Cigarillos | Within the 20-minute survey | 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. |
| Rate of Change for Cigarillo Demand | Within the 20-minute survey | 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Self-Reported Learning | Within the 20-minute survey | 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. |
| Negative Affect | Within the 20-minute survey | 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. |
| Average Total Amount of Non-tobacco Products Purchased | Within the 20-minute survey | 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. |
| Cognitive Elaboration | Within the 20-minute survey | 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. |
| Intentions to Quit Using Cigarillos | Within the 20-minute survey | 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 |
| Warning Recall | Within the 20-minute survey | 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. |
| Warning Recognition | Within the 20-minute survey | 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. |
| Mean Perceived Message Effectiveness | Within the 20-minute survey | 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 |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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.
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. | 526 |
| 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.
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. | 526 |
| 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.
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. | 526 |
| Total | 1,578 |
Baseline characteristics
| Characteristic | Cigarillo Warnings-Surgeon General Text-Only | Total | Cigarillo Warnings-Pictorial | Cigarillo Warnings-FDA Proposed Text-only |
|---|---|---|---|---|
| Age, Continuous | 28.9 Years STANDARD_DEVIATION 4.1 | 28.9 Years STANDARD_DEVIATION 4.2 | 28.9 Years STANDARD_DEVIATION 4.3 | 28.8 Years STANDARD_DEVIATION 4.3 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 54 Participants | 155 Participants | 52 Participants | 49 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 469 Participants | 1415 Participants | 471 Participants | 475 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 3 Participants | 8 Participants | 3 Participants | 2 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 3 Participants | 9 Participants | 2 Participants | 4 Participants |
| Race (NIH/OMB) Asian | 4 Participants | 20 Participants | 8 Participants | 8 Participants |
| Race (NIH/OMB) Black or African American | 262 Participants | 787 Participants | 259 Participants | 266 Participants |
| Race (NIH/OMB) More than one race | 24 Participants | 76 Participants | 24 Participants | 28 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 2 Participants | 2 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 29 Participants | 85 Participants | 32 Participants | 24 Participants |
| Race (NIH/OMB) White | 202 Participants | 599 Participants | 201 Participants | 196 Participants |
| Region of Enrollment United States | 526 participants | 1578 participants | 526 participants | 526 participants |
| Sex/Gender, Customized Female | 283 Participants | 878 Participants | 301 Participants | 294 Participants |
| Sex/Gender, Customized Male | 235 Participants | 680 Participants | 219 Participants | 226 Participants |
| Sex/Gender, Customized Unknown/Not Reported | 8 Participants | 20 Participants | 6 Participants | 6 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 526 | 0 / 526 | 0 / 526 |
| other Total, other adverse events | 0 / 526 | 0 / 526 | 0 / 526 |
| serious Total, serious adverse events | 0 / 526 | 0 / 526 | 0 / 526 |
Outcome results
Primary
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.
Time frame: Within the 20-minute survey
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cigarillo Warnings-Surgeon General Text-Only | Average Total Number of Cigarillos Purchased | Cigarillo price $0.25 | 6.33 cigarillos | Standard Deviation 11.2 |
| Cigarillo Warnings-Surgeon General Text-Only | Average Total Number of Cigarillos Purchased | Cigarillo price $0.50 | 4.98 cigarillos | Standard Deviation 7.91 |
| Cigarillo Warnings-Surgeon General Text-Only | Average Total Number of Cigarillos Purchased | Cigarillo price $6 | 1.00 cigarillos | Standard Deviation 1.62 |
| Cigarillo Warnings-Surgeon General Text-Only | Average Total Number of Cigarillos Purchased | Cigarillo price $0.75 | 4.36 cigarillos | Standard Deviation 7.08 |
| Cigarillo Warnings-Surgeon General Text-Only | Average Total Number of Cigarillos Purchased | Cigarillo price $1.50 | 2.81 cigarillos | Standard Deviation 4.28 |
| Cigarillo Warnings-Surgeon General Text-Only | Average Total Number of Cigarillos Purchased | Cigarillo price $3 | 1.82 cigarillos | Standard Deviation 3.01 |
| Cigarillo Warnings-FDA Proposed Text-only | Average Total Number of Cigarillos Purchased | Cigarillo price $1.50 | 3.66 cigarillos | Standard Deviation 6.96 |
| Cigarillo Warnings-FDA Proposed Text-only | Average Total Number of Cigarillos Purchased | Cigarillo price $3 | 2.19 cigarillos | Standard Deviation 3.83 |
| Cigarillo Warnings-FDA Proposed Text-only | Average Total Number of Cigarillos Purchased | Cigarillo price $0.75 | 5.29 cigarillos | Standard Deviation 10.83 |
| Cigarillo Warnings-FDA Proposed Text-only | Average Total Number of Cigarillos Purchased | Cigarillo price $0.25 | 6.28 cigarillos | Standard Deviation 9.75 |
| Cigarillo Warnings-FDA Proposed Text-only | Average Total Number of Cigarillos Purchased | Cigarillo price $6 | 1.14 cigarillos | Standard Deviation 1.95 |
| Cigarillo Warnings-FDA Proposed Text-only | Average Total Number of Cigarillos Purchased | Cigarillo price $0.50 | 6.45 cigarillos | Standard Deviation 12.44 |
| Cigarillo Warnings-Pictorial | Average Total Number of Cigarillos Purchased | Cigarillo price $6 | 1.04 cigarillos | Standard Deviation 1.77 |
| Cigarillo Warnings-Pictorial | Average Total Number of Cigarillos Purchased | Cigarillo price $0.25 | 6.64 cigarillos | Standard Deviation 10.01 |
| Cigarillo Warnings-Pictorial | Average Total Number of Cigarillos Purchased | Cigarillo price $0.75 | 4.66 cigarillos | Standard Deviation 7.4 |
| Cigarillo Warnings-Pictorial | Average Total Number of Cigarillos Purchased | Cigarillo price $1.50 | 3.09 cigarillos | Standard Deviation 4.38 |
| Cigarillo Warnings-Pictorial | Average Total Number of Cigarillos Purchased | Cigarillo price $3 | 1.96 cigarillos | Standard Deviation 2.81 |
| Cigarillo Warnings-Pictorial | Average Total Number of Cigarillos Purchased | Cigarillo price $0.50 | 6.14 cigarillos | Standard Deviation 10.09 |
Secondary
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
Time frame: Within the 20-minute survey
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cigarillo Warnings-Surgeon General Text-Only | Average Total Amount of mg Combusted Tobacco Purchased | Shopping Trip 1 | 445.06 mg of combusted tobacco purchased | Standard Error 46.29 |
| Cigarillo Warnings-Surgeon General Text-Only | Average Total Amount of mg Combusted Tobacco Purchased | Shopping Trip 2 | 339.39 mg of combusted tobacco purchased | Standard Error 27.34 |
| Cigarillo Warnings-Surgeon General Text-Only | Average Total Amount of mg Combusted Tobacco Purchased | Shopping Trip 3 | 296.12 mg of combusted tobacco purchased | Standard Error 24.37 |
| Cigarillo Warnings-Surgeon General Text-Only | Average Total Amount of mg Combusted Tobacco Purchased | Shopping Trip 4 | 230.15 mg of combusted tobacco purchased | Standard Error 20.73 |
| Cigarillo Warnings-Surgeon General Text-Only | Average Total Amount of mg Combusted Tobacco Purchased | Shopping Trip 5 | 181.61 mg of combusted tobacco purchased | Standard Error 18.5 |
| Cigarillo Warnings-Surgeon General Text-Only | Average Total Amount of mg Combusted Tobacco Purchased | Shopping Trip 6 | 160.71 mg of combusted tobacco purchased | Standard Error 18.3 |
| Cigarillo Warnings-FDA Proposed Text-only | Average Total Amount of mg Combusted Tobacco Purchased | Shopping Trip 6 | 171.90 mg of combusted tobacco purchased | Standard Error 18.6 |
| Cigarillo Warnings-FDA Proposed Text-only | Average Total Amount of mg Combusted Tobacco Purchased | Shopping Trip 1 | 404.52 mg of combusted tobacco purchased | Standard Error 30.56 |
| Cigarillo Warnings-FDA Proposed Text-only | Average Total Amount of mg Combusted Tobacco Purchased | Shopping Trip 4 | 274.97 mg of combusted tobacco purchased | Standard Error 23.35 |
| Cigarillo Warnings-FDA Proposed Text-only | Average Total Amount of mg Combusted Tobacco Purchased | Shopping Trip 5 | 213.83 mg of combusted tobacco purchased | Standard Error 20.12 |
| Cigarillo Warnings-FDA Proposed Text-only | Average Total Amount of mg Combusted Tobacco Purchased | Shopping Trip 2 | 416.61 mg of combusted tobacco purchased | Standard Error 34.95 |
| Cigarillo Warnings-FDA Proposed Text-only | Average Total Amount of mg Combusted Tobacco Purchased | Shopping Trip 3 | 363.16 mg of combusted tobacco purchased | Standard Error 33.61 |
| Cigarillo Warnings-Pictorial | Average Total Amount of mg Combusted Tobacco Purchased | Shopping Trip 2 | 401.25 mg of combusted tobacco purchased | Standard Error 38.88 |
| Cigarillo Warnings-Pictorial | Average Total Amount of mg Combusted Tobacco Purchased | Shopping Trip 3 | 360.90 mg of combusted tobacco purchased | Standard Error 33.81 |
| Cigarillo Warnings-Pictorial | Average Total Amount of mg Combusted Tobacco Purchased | Shopping Trip 6 | 168.82 mg of combusted tobacco purchased | Standard Error 19.88 |
| Cigarillo Warnings-Pictorial | Average Total Amount of mg Combusted Tobacco Purchased | Shopping Trip 4 | 277.28 mg of combusted tobacco purchased | Standard Error 29.8 |
| Cigarillo Warnings-Pictorial | Average Total Amount of mg Combusted Tobacco Purchased | Shopping Trip 1 | 395.66 mg of combusted tobacco purchased | Standard Error 27.59 |
| Cigarillo Warnings-Pictorial | Average Total Amount of mg Combusted Tobacco Purchased | Shopping Trip 5 | 219.56 mg of combusted tobacco purchased | Standard Error 28.03 |
Secondary
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.
Time frame: Within the 20-minute survey
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cigarillo Warnings-Surgeon General Text-Only | Average Total Amount of mg Non-combusted Tobacco Purchased | Shopping Trip 1 | 134.81 mg of non-combusted tobacco purchased | Standard Error 17.75 |
| Cigarillo Warnings-Surgeon General Text-Only | Average Total Amount of mg Non-combusted Tobacco Purchased | Shopping Trip 2 | 106.68 mg of non-combusted tobacco purchased | Standard Error 11.19 |
| Cigarillo Warnings-Surgeon General Text-Only | Average Total Amount of mg Non-combusted Tobacco Purchased | Shopping Trip 3 | 120.26 mg of non-combusted tobacco purchased | Standard Error 18.11 |
| Cigarillo Warnings-Surgeon General Text-Only | Average Total Amount of mg Non-combusted Tobacco Purchased | Shopping Trip 4 | 92.73 mg of non-combusted tobacco purchased | Standard Error 10.76 |
| Cigarillo Warnings-Surgeon General Text-Only | Average Total Amount of mg Non-combusted Tobacco Purchased | Shopping Trip 5 | 73.07 mg of non-combusted tobacco purchased | Standard Error 8.37 |
| Cigarillo Warnings-Surgeon General Text-Only | Average Total Amount of mg Non-combusted Tobacco Purchased | Shopping Trip 6 | 67.79 mg of non-combusted tobacco purchased | Standard Error 8.4 |
| Cigarillo Warnings-FDA Proposed Text-only | Average Total Amount of mg Non-combusted Tobacco Purchased | Shopping Trip 6 | 70.37 mg of non-combusted tobacco purchased | Standard Error 7.49 |
| Cigarillo Warnings-FDA Proposed Text-only | Average Total Amount of mg Non-combusted Tobacco Purchased | Shopping Trip 1 | 133.72 mg of non-combusted tobacco purchased | Standard Error 18.23 |
| Cigarillo Warnings-FDA Proposed Text-only | Average Total Amount of mg Non-combusted Tobacco Purchased | Shopping Trip 4 | 116.16 mg of non-combusted tobacco purchased | Standard Error 22.73 |
| Cigarillo Warnings-FDA Proposed Text-only | Average Total Amount of mg Non-combusted Tobacco Purchased | Shopping Trip 5 | 81.28 mg of non-combusted tobacco purchased | Standard Error 9.48 |
| Cigarillo Warnings-FDA Proposed Text-only | Average Total Amount of mg Non-combusted Tobacco Purchased | Shopping Trip 2 | 122.98 mg of non-combusted tobacco purchased | Standard Error 22.81 |
| Cigarillo Warnings-FDA Proposed Text-only | Average Total Amount of mg Non-combusted Tobacco Purchased | Shopping Trip 3 | 108.97 mg of non-combusted tobacco purchased | Standard Error 11.54 |
| Cigarillo Warnings-Pictorial | Average Total Amount of mg Non-combusted Tobacco Purchased | Shopping Trip 2 | 126.93 mg of non-combusted tobacco purchased | Standard Error 17.02 |
| Cigarillo Warnings-Pictorial | Average Total Amount of mg Non-combusted Tobacco Purchased | Shopping Trip 3 | 102.30 mg of non-combusted tobacco purchased | Standard Error 14.35 |
| Cigarillo Warnings-Pictorial | Average Total Amount of mg Non-combusted Tobacco Purchased | Shopping Trip 6 | 75.45 mg of non-combusted tobacco purchased | Standard Error 9.29 |
| Cigarillo Warnings-Pictorial | Average Total Amount of mg Non-combusted Tobacco Purchased | Shopping Trip 4 | 82.43 mg of non-combusted tobacco purchased | Standard Error 9.38 |
| Cigarillo Warnings-Pictorial | Average Total Amount of mg Non-combusted Tobacco Purchased | Shopping Trip 1 | 148.93 mg of non-combusted tobacco purchased | Standard Error 20.12 |
| Cigarillo Warnings-Pictorial | Average Total Amount of mg Non-combusted Tobacco Purchased | Shopping Trip 5 | 82.46 mg of non-combusted tobacco purchased | Standard Error 9.89 |
Secondary
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.
Time frame: Within the 20-minute survey
Population: For this index, participants were removed whose baseline balance was insufficient to purchase any products and people who did not purchase anything. Another 50 cases were removed for violating modified bounce criterion.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cigarillo Warnings-Surgeon General Text-Only | Cost Related Indices for Cigarillos | Breakpoint-price where no cigarillos purchased | 6.05 dollars | Standard Deviation 3.47 |
| Cigarillo Warnings-Surgeon General Text-Only | Cost Related Indices for Cigarillos | Omax-maximum amount spent across all shopping trips | 8.91 dollars | Standard Deviation 10.46 |
| Cigarillo Warnings-Surgeon General Text-Only | Cost Related Indices for Cigarillos | Pmax-price where Omax occurs | 3.05 dollars | Standard Deviation 2.27 |
| Cigarillo Warnings-FDA Proposed Text-only | Cost Related Indices for Cigarillos | Breakpoint-price where no cigarillos purchased | 6.40 dollars | Standard Deviation 3.27 |
| Cigarillo Warnings-FDA Proposed Text-only | Cost Related Indices for Cigarillos | Omax-maximum amount spent across all shopping trips | 9.89 dollars | Standard Deviation 12.35 |
| Cigarillo Warnings-FDA Proposed Text-only | Cost Related Indices for Cigarillos | Pmax-price where Omax occurs | 3.19 dollars | Standard Deviation 2.26 |
| Cigarillo Warnings-Pictorial | Cost Related Indices for Cigarillos | Omax-maximum amount spent across all shopping trips | 9.47 dollars | Standard Deviation 11.1 |
| Cigarillo Warnings-Pictorial | Cost Related Indices for Cigarillos | Pmax-price where Omax occurs | 3.04 dollars | Standard Deviation 2.22 |
| Cigarillo Warnings-Pictorial | Cost Related Indices for Cigarillos | Breakpoint-price where no cigarillos purchased | 6.37 dollars | Standard Deviation 5.59 |
Secondary
Intensity Index for Cigarillos
Number of cigarillos purchased at lowest price, averaged across the six shopping trips
Time frame: Within the 20 minute survey.
Population: For this index, participants were removed whose baseline balance was insufficient to purchase any products and people who did not purchase anything. Another 50 cases were removed for violating modified bounce criterion.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Cigarillo Warnings-Surgeon General Text-Only | Intensity Index for Cigarillos | 6.33 number of cigarillos | Standard Deviation 11.2 |
| Cigarillo Warnings-FDA Proposed Text-only | Intensity Index for Cigarillos | 6.28 number of cigarillos | Standard Deviation 9.75 |
| Cigarillo Warnings-Pictorial | Intensity Index for Cigarillos | 6.64 number of cigarillos | Standard Deviation 10.01 |
Secondary
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.
Time frame: Within the 20-minute survey
Population: For Alpha, cases were removed for negative alphas values indicating poor/implausible fits. Cases were were also removed for negative curvature to the data (i.e., a mostly flat line), which does not allow alpha to be generated. Additional cases for each group were removed if alpha could not be calculated leading to the smaller numbers of participants analyzed in each group.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Cigarillo Warnings-Surgeon General Text-Only | Rate of Change for Cigarillo Demand | 0.03 cigarillos/dollar | Standard Deviation 0.05 |
| Cigarillo Warnings-FDA Proposed Text-only | Rate of Change for Cigarillo Demand | 0.02 cigarillos/dollar | Standard Deviation 0.03 |
| Cigarillo Warnings-Pictorial | Rate of Change for Cigarillo Demand | 0.03 cigarillos/dollar | Standard Deviation 0.05 |
Other Pre-specified
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.
Time frame: Within the 20-minute survey
Other Pre-specified
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.
Time frame: Within the 20-minute survey
Other Pre-specified
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
Time frame: Within the 20-minute survey
Other Pre-specified
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
Time frame: Within the 20-minute survey
Other Pre-specified
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.
Time frame: Within the 20-minute survey
Other Pre-specified
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.
Time frame: Within the 20-minute survey
Other Pre-specified
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.
Time frame: Within the 20-minute survey
Other Pre-specified
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.
Time frame: Within the 20-minute survey