Tobacco Use
Conditions
Keywords
Cigar Warnings, Little Cigar Use, Cigar Use, Cigarillo Use
Brief summary
The goal of this research is to assess whether little Cigars and cigarillos (LCC) warnings developed by the study team are more effective than the current warnings proposed by FDA for LCC products. A 3-week web-based randomized controlled trial will be conducted in the United States. Participants are adult persons who currently use LCCs.
Detailed description
In this study, LCC warnings on packs will be electronically presented to participants over time to determine if newly developed LCC warnings increase quit intentions compared to FDA-proposed text-only warnings and a control condition (in which participants do not see LCC packs or warnings.) A daily diary methodology will be employed to present LCC warnings on packs to participants over time. Qualtrics will contact, screen, consent, and administer the survey. To enroll participants, Qualtrics will screen participants using the inclusion criteria and measures and invite eligible participants to enroll in the study. At the beginning of the baseline survey (day 0), participants will first consent to participate in the study and then complete a questionnaire about their tobacco use and behaviors (e.g., intentions and quit attempts) and other measures of interest. At the end of the baseline questionnaire, survey software will randomly assign participants to one of the 3 study conditions. The three study conditions are 1) Newly developed warnings with images (the six most effective warnings developed by the study team), 2) FDA-proposed text-only warnings, or 3) control condition in which participants will not receive an intervention (no warnings). Participants will be contacted via email each day (at approximately 6 am) to invite them to complete the survey for that day of the study protocol. For subsequent days (days 1-6, 8-13, 15-20) participants will be contacted and asked to complete a daily survey which will assess their previous day use of LCCs, as well as cigarettes and e-cigarettes. During these daily surveys, participants assigned to condition 1 or 2 (i.e., the warning conditions) will view an image of a little cigar and cigarillo package with a warning according to the participant's condition. Participants within each warning condition will view a total of 6 different warnings over the course of 6 days each week, this will be repeated 3 times during the study, resulting in a total of 18 exposures. Participants will be required to view the warning for at least 5 seconds before answering questions. On days 7 and 14 participants will be asked to complete a slightly longer survey with questions about their LCC behaviors including the number of LCCs used in the past week, the number of LCCs butted out because they wanted to smoke less, the number of LCCs forgone, other tobacco use, blunt use, and quit intentions and attempts. For the post-test on day 21, participants will be asked to complete a longer questionnaire about their current tobacco use and behaviors including current LCC smoking behavior, LCC nicotine dependence, other tobacco product (OTP) use, LCC and OTP quit intentions, and LCC and O
Interventions
BEHAVIORALNewly developed warnings with images at 30% size
On study days 1-6, 8-13 and 15-20, participants in this condition will view an image of a little cigar and cigarillo package with a warning developed by the study team that includes an image. The warnings will take up 30% of the package. Participants will view a total of 6 different warnings over the course of 6 days each week, this will be repeated 3 times during the study, resulting in a total of 18 exposures. Participants will be required to view the warning for at least 5 seconds.
BEHAVIORALFDA proposed text-only warnings at 30% size
On study days 1-6, 8-13 and 15-20, participants in this condition will view an image of a little cigar and cigarillo package with a warning proposed by the FDA which is text only. The warnings will take up 30% of the package. Participants will view a total of 6 different warnings over the course of 6 days each week, this will be repeated 3 times during the study, resulting in a total of 18 exposures. Participants will be required to view the warning for at least 5 seconds.
Sponsors
National Cancer Institute (NCI)
UNC Lineberger Comprehensive Cancer Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Members of the recruitment panel (the investigators are partnering with a panel provider for recruitment of all participants) * Agree to provide their honest answers * Current little cigar and/or cigarillo every day or some day users * Over 21 years old * Currently living in US * Feel comfortable taking a survey in English without help * Feel comfortable taking an online survey without help * Have an email address that they check regularly * Have access to the internet at work or home * Able to read and respond to surveys delivered to their email * Able to complete 2 surveys that take approximately 20 minutes * Able to complete a 5 minute survey each day for 20 days * Able to verify they are not a bot using CAPTCHA * Able to answer a simple, random math question
Exclusion criteria
* None
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| LCC Quit Intentions | day 21 (post test) | Average quit intention score measured by survey. Quit intention measured with 3 questions, the final quit intention score is a mean of the response to the 3 questions, on a scale of 1 to 4, where 1 indicates low intention to quit, and 4 indicates a high intention to quit. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Days Smoked LCCs in Past Week | day 7 | The mean number days that a participant reported smoking little cigars and cigarillos (LCCs) smoked in the past week |
| Number of LCCs Smoked in the Past Week | day 7 | The mean number of little cigars and cigarillos (LCCs) smoked in the past week reported by participant |
| Number of LCCs Butted Out in the Past Week | day 7 | The mean number of little cigars and cigarillos (LCCs) that participants reported butting out in the past week |
| Number of LCCs Smoked in Past Day | day 1 | The mean number of little cigars and cigarillos (LCCs) smoked in the past day reported by participant. |
| LCC Quit Attempts in Past Week | day 7 | The number and percent of participants who reported trying to quit smoking little cigars and cigarillos (LCCs) in the past week |
| LCC Quit Intentions | day 7 | Average quit intention score measured by survey. Quit intention measured with 3 questions, the final quit intention score is a mean of the response to the 3 questions, on a scale of 1 to 4, where 1 indicates low intention to quit, and 4 indicates a high intention to quit. |
| Self Reported Learning | day 21 (post test) | Mean self-reported learning reported by participants. Self-reported learning measured with one item on a 1 to 5 scale, where 1 indicates no learning, and 5 indicates a great deal of learning from the warnings in the study. Self reported learning is only measured in conditions 1 and 2, the conditions that receive warnings. |
| Number of LCCs Forgone in the Past Week | day 7 | The mean number of little cigars and cigarillos (LCCs) that participants reported forgoing in the past week |
Countries
United States
Participant flow
Recruitment details
Participants were recruited and screened for study eligiblity online between May and August 2024, and invited to in the study once they were determined to be eligible.
Pre-assignment details
1,114 potential participants began the baseline survey. Of those, 44 did not consent to participate in the study, and 41 did not complete the baseline questionnaire and were not randomized. 1,029 participants were enrolled and randomized in the study.
Participants by arm
| Arm | Count |
|---|---|
| Newly Developed Warnings With Images Participants receive newly developed warnings intervention
Newly developed warnings with images at 30% size: On study days 1-6, 8-13 and 15-20, participants in this condition will view an image of a little cigar and cigarillo package with a warning developed by the study team that includes an image. The warnings will take up 30% of the package. Participants will view a total of 6 different warnings over the course of 6 days each week, this will be repeated 3 times during the study, resulting in a total of 18 exposures. Participants will be required to view the warning for at least 5 seconds. | 339 |
| FDA Proposed Text-only Warnings Participants receive FDA proposed text only warning intervention
FDA proposed text-only warnings at 30% size: On study days 1-6, 8-13 and 15-20, participants in this condition will view an image of a little cigar and cigarillo package with a warning proposed by the FDA which is text only. The warnings will take up 30% of the package. Participants will view a total of 6 different warnings over the course of 6 days each week, this will be repeated 3 times during the study, resulting in a total of 18 exposures. Participants will be required to view the warning for at least 5 seconds. | 346 |
| Control Group, no Intervention Participants do not receive an intervention | 344 |
| Total | 1,029 |
Baseline characteristics
| Characteristic | FDA Proposed Text-only Warnings | Newly Developed Warnings With Images | Total | Control Group, no Intervention |
|---|---|---|---|---|
| Age, Continuous | 44.48 years STANDARD_DEVIATION 11.73 | 43.03 years STANDARD_DEVIATION 10.44 | 43.86 years STANDARD_DEVIATION 11.29 | 44.07 years STANDARD_DEVIATION 11.61 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 50 Participants | 68 Participants | 170 Participants | 52 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 294 Participants | 270 Participants | 855 Participants | 291 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 2 Participants | 1 Participants | 4 Participants | 1 Participants |
| Race/Ethnicity, Customized American Indian or Alaska Native | 4 Participants | 5 Participants | 10 Participants | 1 Participants |
| Race/Ethnicity, Customized Asian | 13 Participants | 21 Participants | 53 Participants | 19 Participants |
| Race/Ethnicity, Customized Black/African American | 70 Participants | 70 Participants | 217 Participants | 77 Participants |
| Race/Ethnicity, Customized More than one Race | 20 Participants | 24 Participants | 65 Participants | 21 Participants |
| Race/Ethnicity, Customized Native Hawaiian/Pacific Islander | 1 Participants | 0 Participants | 2 Participants | 1 Participants |
| Race/Ethnicity, Customized Unknown not reported | 10 Participants | 16 Participants | 37 Participants | 11 Participants |
| Race/Ethnicity, Customized White | 228 Participants | 203 Participants | 645 Participants | 214 Participants |
| Region of Enrollment United States | 346 participants | 339 participants | 1029 participants | 344 participants |
| Sex/Gender, Customized Another Gender | 0 Participants | 1 Participants | 2 Participants | 1 Participants |
| Sex/Gender, Customized Female | 138 Participants | 163 Participants | 449 Participants | 148 Participants |
| Sex/Gender, Customized Male | 208 Participants | 175 Participants | 578 Participants | 195 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 0 | 0 / 0 | 0 / 0 |
| other Total, other adverse events | 0 / 0 | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 | 0 / 0 | 0 / 0 |
Outcome results
Primary
LCC Quit Intentions
Average quit intention score measured by survey. Quit intention measured with 3 questions, the final quit intention score is a mean of the response to the 3 questions, on a scale of 1 to 4, where 1 indicates low intention to quit, and 4 indicates a high intention to quit.
Time frame: day 21 (post test)
Population: Participants who responded to the scale at the time point of interest, post test on day 21
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Newly Developed Warnings With Images | LCC Quit Intentions | 2.9 score on a scale | Standard Deviation 1.1 |
| FDA Proposed Text-only Warnings | LCC Quit Intentions | 2.49 score on a scale | Standard Deviation 1.12 |
| Control Group, no Intervention | LCC Quit Intentions | 2.54 score on a scale | Standard Deviation 1.09 |
Secondary
LCC Quit Attempts in Past Week
The number and percent of participants who reported trying to quit smoking little cigars and cigarillos (LCCs) in the past week
Time frame: day 14
Population: Participants who responded to the measures at the time point of interest, day 14
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Newly Developed Warnings With Images | LCC Quit Attempts in Past Week | 102 Participants |
| FDA Proposed Text-only Warnings | LCC Quit Attempts in Past Week | 71 Participants |
| Control Group, no Intervention | LCC Quit Attempts in Past Week | 66 Participants |
Secondary
LCC Quit Attempts in Past Week
The number and percent of participants who reported trying to quit smoking little cigars and cigarillos (LCCs) in the past week
Time frame: day 21 (post test)
Population: Participants who responded to the measures at the time point of interest, day 21 (post test)
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Newly Developed Warnings With Images | LCC Quit Attempts in Past Week | 134 Participants |
| FDA Proposed Text-only Warnings | LCC Quit Attempts in Past Week | 90 Participants |
| Control Group, no Intervention | LCC Quit Attempts in Past Week | 86 Participants |
Secondary
LCC Quit Attempts in Past Week
The number and percent of participants who reported trying to quit smoking little cigars and cigarillos (LCCs) in the past week
Time frame: day 7
Population: Participants who responded to the measures at the time point of interest, day 7
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Newly Developed Warnings With Images | LCC Quit Attempts in Past Week | 108 Participants |
| FDA Proposed Text-only Warnings | LCC Quit Attempts in Past Week | 61 Participants |
| Control Group, no Intervention | LCC Quit Attempts in Past Week | 62 Participants |
Secondary
LCC Quit Intentions
Average quit intention score measured by survey. Quit intention measured with 3 questions, the final quit intention score is a mean of the response to the 3 questions, on a scale of 1 to 4, where 1 indicates low intention to quit, and 4 indicates a high intention to quit.
Time frame: day 7
Population: Participants who responded to the scale at the time point of interest, day 7
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Newly Developed Warnings With Images | LCC Quit Intentions | 2.76 score on a scale | Standard Deviation 1.07 |
| FDA Proposed Text-only Warnings | LCC Quit Intentions | 2.33 score on a scale | Standard Deviation 1.05 |
| Control Group, no Intervention | LCC Quit Intentions | 2.46 score on a scale | Standard Deviation 1.04 |
Secondary
LCC Quit Intentions
Average quit intention score measured by survey. Quit intention measured with 3 questions, the final quit intention score is a mean of the response to the 3 questions, on a scale of 1 to 4, where 1 indicates low intention to quit, and 4 indicates a high intention to quit.
Time frame: day 14
Population: Participants who responded to the scale at the time point of interest, day 14
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Newly Developed Warnings With Images | LCC Quit Intentions | 2.82 score on a scale | Standard Deviation 1.08 |
| FDA Proposed Text-only Warnings | LCC Quit Intentions | 2.42 score on a scale | Standard Deviation 1.09 |
| Control Group, no Intervention | LCC Quit Intentions | 2.51 score on a scale | Standard Deviation 1.04 |
Secondary
Number of Days Smoked LCCs in Past Week
The mean number days that a participant reported smoking little cigars and cigarillos (LCCs) smoked in the past week
Time frame: day 21 (post test)
Population: Participants who responded to the measures at the time point of interest, day 21 (post test)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Newly Developed Warnings With Images | Number of Days Smoked LCCs in Past Week | 3.15 number of days | Standard Deviation 2.44 |
| FDA Proposed Text-only Warnings | Number of Days Smoked LCCs in Past Week | 3.46 number of days | Standard Deviation 2.47 |
| Control Group, no Intervention | Number of Days Smoked LCCs in Past Week | 3.41 number of days | Standard Deviation 2.29 |
Secondary
Number of Days Smoked LCCs in Past Week
The mean number days that a participant reported smoking little cigars and cigarillos (LCCs) smoked in the past week
Time frame: day 7
Population: Participants who responded to the measures at the time point of interest, day 7
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Newly Developed Warnings With Images | Number of Days Smoked LCCs in Past Week | 3.46 number of days | Standard Deviation 2.29 |
| FDA Proposed Text-only Warnings | Number of Days Smoked LCCs in Past Week | 3.58 number of days | Standard Deviation 2.31 |
| Control Group, no Intervention | Number of Days Smoked LCCs in Past Week | 3.46 number of days | Standard Deviation 2.25 |
Secondary
Number of Days Smoked LCCs in Past Week
The mean number days that a participant reported smoking little cigars and cigarillos (LCCs) smoked in the past week
Time frame: day 14
Population: Participants who responded to the measures at the time point of interest, day 14
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Newly Developed Warnings With Images | Number of Days Smoked LCCs in Past Week | 3.26 number of days | Standard Deviation 2.4 |
| FDA Proposed Text-only Warnings | Number of Days Smoked LCCs in Past Week | 3.50 number of days | Standard Deviation 2.38 |
| Control Group, no Intervention | Number of Days Smoked LCCs in Past Week | 3.45 number of days | Standard Deviation 2.28 |
Secondary
Number of LCCs Butted Out in the Past Week
The mean number of little cigars and cigarillos (LCCs) that participants reported butting out in the past week
Time frame: day 21 (post test)
Population: Participants who responded to the measures at the time point of interest, day 21 (post test)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Newly Developed Warnings With Images | Number of LCCs Butted Out in the Past Week | 3.11 number of LCCs | Standard Deviation 5.41 |
| FDA Proposed Text-only Warnings | Number of LCCs Butted Out in the Past Week | 3.46 number of LCCs | Standard Deviation 14.93 |
| Control Group, no Intervention | Number of LCCs Butted Out in the Past Week | 2.81 number of LCCs | Standard Deviation 5.67 |
Secondary
Number of LCCs Butted Out in the Past Week
The mean number of little cigars and cigarillos (LCCs) that participants reported butting out in the past week
Time frame: day 7
Population: Participants who responded to the measures at the time point of interest, day 7
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Newly Developed Warnings With Images | Number of LCCs Butted Out in the Past Week | 4.24 number of LCCs | Standard Deviation 7.86 |
| FDA Proposed Text-only Warnings | Number of LCCs Butted Out in the Past Week | 3.64 number of LCCs | Standard Deviation 18.09 |
| Control Group, no Intervention | Number of LCCs Butted Out in the Past Week | 3.03 number of LCCs | Standard Deviation 6.51 |
Secondary
Number of LCCs Butted Out in the Past Week
The mean number of little cigars and cigarillos (LCCs) that participants reported butting out in the past week
Time frame: day 14
Population: Participants who responded to the measures at the time point of interest, day 14
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Newly Developed Warnings With Images | Number of LCCs Butted Out in the Past Week | 3.11 number of LCCs | Standard Deviation 5.22 |
| FDA Proposed Text-only Warnings | Number of LCCs Butted Out in the Past Week | 3.48 number of LCCs | Standard Deviation 15.53 |
| Control Group, no Intervention | Number of LCCs Butted Out in the Past Week | 2.59 number of LCCs | Standard Deviation 5.71 |
Secondary
Number of LCCs Forgone in the Past Week
The mean number of little cigars and cigarillos (LCCs) that participants reported forgoing in the past week
Time frame: day 7
Population: Participants who responded to the measures at the time point of interest, day 7
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Newly Developed Warnings With Images | Number of LCCs Forgone in the Past Week | 3.85 number of LCCs | Standard Deviation 5.24 |
| FDA Proposed Text-only Warnings | Number of LCCs Forgone in the Past Week | 3.64 number of LCCs | Standard Deviation 17.62 |
| Control Group, no Intervention | Number of LCCs Forgone in the Past Week | 2.88 number of LCCs | Standard Deviation 4.83 |
Secondary
Number of LCCs Forgone in the Past Week
The mean number of little cigars and cigarillos (LCCs) that participants reported forgoing in the past week
Time frame: day 14
Population: Participants who responded to the measures at the time point of interest, day 14
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Newly Developed Warnings With Images | Number of LCCs Forgone in the Past Week | 6.79 number of LCCs | Standard Deviation 30.85 |
| FDA Proposed Text-only Warnings | Number of LCCs Forgone in the Past Week | 3.47 number of LCCs | Standard Deviation 15.39 |
| Control Group, no Intervention | Number of LCCs Forgone in the Past Week | 2.81 number of LCCs | Standard Deviation 4.31 |
Secondary
Number of LCCs Forgone in the Past Week
The mean number of little cigars and cigarillos (LCCs) that participants reported forgoing in the past week
Time frame: day 21 (post test)
Population: Participants who responded to the measures at the time point of interest, day 21 (post test)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Newly Developed Warnings With Images | Number of LCCs Forgone in the Past Week | 5.69 number of LCCs | Standard Deviation 14.67 |
| FDA Proposed Text-only Warnings | Number of LCCs Forgone in the Past Week | 4.30 number of LCCs | Standard Deviation 15.95 |
| Control Group, no Intervention | Number of LCCs Forgone in the Past Week | 3.46 number of LCCs | Standard Deviation 7.3 |
Secondary
Number of LCCs Smoked in Past Day
The mean number of little cigars and cigarillos (LCCs) smoked in the past day reported by participant
Time frame: day 13
Population: Participants who responded to the measures at the time point of interest, day 13
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Newly Developed Warnings With Images | Number of LCCs Smoked in Past Day | 2.62 number of LCCs | Standard Deviation 3.86 |
| FDA Proposed Text-only Warnings | Number of LCCs Smoked in Past Day | 2.79 number of LCCs | Standard Deviation 4.61 |
| Control Group, no Intervention | Number of LCCs Smoked in Past Day | 2.50 number of LCCs | Standard Deviation 3.38 |
Secondary
Number of LCCs Smoked in Past Day
The mean number of little cigars and cigarillos (LCCs) smoked in the past day reported by participant
Time frame: day 14
Population: Participants who responded to the measures at the time point of interest, day 14
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Newly Developed Warnings With Images | Number of LCCs Smoked in Past Day | 2.19 number of LCCs | Standard Deviation 3.24 |
| FDA Proposed Text-only Warnings | Number of LCCs Smoked in Past Day | 2.44 number of LCCs | Standard Deviation 4.58 |
| Control Group, no Intervention | Number of LCCs Smoked in Past Day | 2.24 number of LCCs | Standard Deviation 3.47 |
Secondary
Number of LCCs Smoked in Past Day
The mean number of little cigars and cigarillos (LCCs) smoked in the past day reported by participant
Time frame: day 15
Population: Participants who responded to the measures at the time point of interest, day 15
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Newly Developed Warnings With Images | Number of LCCs Smoked in Past Day | 2.35 number of LCCs | Standard Deviation 4.27 |
| FDA Proposed Text-only Warnings | Number of LCCs Smoked in Past Day | 2.56 number of LCCs | Standard Deviation 4.46 |
| Control Group, no Intervention | Number of LCCs Smoked in Past Day | 2.26 number of LCCs | Standard Deviation 3.39 |
Secondary
Number of LCCs Smoked in Past Day
The mean number of little cigars and cigarillos (LCCs) smoked in the past day reported by participant
Time frame: day 16
Population: Participants who responded to the measures at the time point of interest, day 16
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Newly Developed Warnings With Images | Number of LCCs Smoked in Past Day | 2.21 number of LCCs | Standard Deviation 3.07 |
| FDA Proposed Text-only Warnings | Number of LCCs Smoked in Past Day | 2.62 number of LCCs | Standard Deviation 4.43 |
| Control Group, no Intervention | Number of LCCs Smoked in Past Day | 2.35 number of LCCs | Standard Deviation 3.57 |
Secondary
Number of LCCs Smoked in Past Day
The mean number of little cigars and cigarillos (LCCs) smoked in the past day reported by participant
Time frame: day 17
Population: Participants who responded to the measures at the time point of interest, day 17
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Newly Developed Warnings With Images | Number of LCCs Smoked in Past Day | 2.23 number of LCCs | Standard Deviation 3.38 |
| FDA Proposed Text-only Warnings | Number of LCCs Smoked in Past Day | 2.62 number of LCCs | Standard Deviation 4.35 |
| Control Group, no Intervention | Number of LCCs Smoked in Past Day | 2.38 number of LCCs | Standard Deviation 3.58 |
Secondary
Number of LCCs Smoked in Past Day
The mean number of little cigars and cigarillos (LCCs) smoked in the past day reported by participant
Time frame: day 18
Population: Participants who responded to the measures at the time point of interest, day 18
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Newly Developed Warnings With Images | Number of LCCs Smoked in Past Day | 2.26 number of LCCs | Standard Deviation 3.33 |
| FDA Proposed Text-only Warnings | Number of LCCs Smoked in Past Day | 2.87 number of LCCs | Standard Deviation 4.51 |
| Control Group, no Intervention | Number of LCCs Smoked in Past Day | 2.47 number of LCCs | Standard Deviation 3.36 |
Secondary
Number of LCCs Smoked in Past Day
The mean number of little cigars and cigarillos (LCCs) smoked in the past day reported by participant
Time frame: day 20
Population: Participants who responded to the measures at the time point of interest, day 20
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Newly Developed Warnings With Images | Number of LCCs Smoked in Past Day | 2.18 number of LCCs | Standard Deviation 3.46 |
| FDA Proposed Text-only Warnings | Number of LCCs Smoked in Past Day | 2.62 number of LCCs | Standard Deviation 4.25 |
| Control Group, no Intervention | Number of LCCs Smoked in Past Day | 2.36 number of LCCs | Standard Deviation 3.4 |
Secondary
Number of LCCs Smoked in Past Day
The mean number of little cigars and cigarillos (LCCs) smoked in the past day reported by participant
Time frame: day 21 (post test)
Population: Participants who responded to the measures at the time point of interest, day 21 (post test)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Newly Developed Warnings With Images | Number of LCCs Smoked in Past Day | 2.13 number of LCCs | Standard Deviation 3.3 |
| FDA Proposed Text-only Warnings | Number of LCCs Smoked in Past Day | 2.34 number of LCCs | Standard Deviation 3.36 |
| Control Group, no Intervention | Number of LCCs Smoked in Past Day | 2.43 number of LCCs | Standard Deviation 4.58 |
Secondary
Number of LCCs Smoked in Past Day
The mean number of little cigars and cigarillos (LCCs) smoked in the past day reported by participant.
Time frame: day 1
Population: Participants who responded to the measures at the time point of interest, day 1
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Newly Developed Warnings With Images | Number of LCCs Smoked in Past Day | 2.75 number of LCCs | Standard Deviation 4.09 |
| FDA Proposed Text-only Warnings | Number of LCCs Smoked in Past Day | 2.47 number of LCCs | Standard Deviation 3.14 |
| Control Group, no Intervention | Number of LCCs Smoked in Past Day | 2.28 number of LCCs | Standard Deviation 2.85 |
Secondary
Number of LCCs Smoked in Past Day
The mean number of little cigars and cigarillos (LCCs) smoked in the past day reported by participant
Time frame: day 2
Population: Participants who responded to the measures at the time point of interest, day 2
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Newly Developed Warnings With Images | Number of LCCs Smoked in Past Day | 2.43 number of LCCs | Standard Deviation 3.09 |
| FDA Proposed Text-only Warnings | Number of LCCs Smoked in Past Day | 2.62 number of LCCs | Standard Deviation 3.3 |
| Control Group, no Intervention | Number of LCCs Smoked in Past Day | 2.21 number of LCCs | Standard Deviation 2.79 |
Secondary
Number of LCCs Smoked in Past Day
The mean number of little cigars and cigarillos (LCCs) smoked in the past day reported by participant
Time frame: day 19
Population: Participants who responded to the measures at the time point of interest, day 19
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Newly Developed Warnings With Images | Number of LCCs Smoked in Past Day | 2.27 number of LCCs | Standard Deviation 3.38 |
| FDA Proposed Text-only Warnings | Number of LCCs Smoked in Past Day | 2.85 number of LCCs | Standard Deviation 4.36 |
| Control Group, no Intervention | Number of LCCs Smoked in Past Day | 2.38 number of LCCs | Standard Deviation 3.39 |
Secondary
Number of LCCs Smoked in Past Day
The mean number of little cigars and cigarillos (LCCs) smoked in the past day was reported by participants.
Time frame: day 3
Population: Participants who responded to the measures at the time point of interest, day 3
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Newly Developed Warnings With Images | Number of LCCs Smoked in Past Day | 2.56 number of LCCs | Standard Deviation 3.17 |
| FDA Proposed Text-only Warnings | Number of LCCs Smoked in Past Day | 2.66 number of LCCs | Standard Deviation 3.13 |
| Control Group, no Intervention | Number of LCCs Smoked in Past Day | 2.44 number of LCCs | Standard Deviation 2.86 |
Secondary
Number of LCCs Smoked in Past Day
The mean number of little cigars and cigarillos (LCCs) smoked in the past day reported by participant.
Time frame: day 4
Population: Participants who responded to the measures at the time point of interest, day 4
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Newly Developed Warnings With Images | Number of LCCs Smoked in Past Day | 2.66 number of LCCs | Standard Deviation 3.51 |
| FDA Proposed Text-only Warnings | Number of LCCs Smoked in Past Day | 3.04 number of LCCs | Standard Deviation 4.46 |
| Control Group, no Intervention | Number of LCCs Smoked in Past Day | 2.50 number of LCCs | Standard Deviation 2.95 |
Secondary
Number of LCCs Smoked in Past Day
The mean number of little cigars and cigarillos (LCCs) smoked in the past day reported by participant
Time frame: day 5
Population: Participants who responded to the measures at the time point of interest, day 5
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Newly Developed Warnings With Images | Number of LCCs Smoked in Past Day | 2.77 number of LCCs | Standard Deviation 3.67 |
| FDA Proposed Text-only Warnings | Number of LCCs Smoked in Past Day | 3.07 number of LCCs | Standard Deviation 4.21 |
| Control Group, no Intervention | Number of LCCs Smoked in Past Day | 2.43 number of LCCs | Standard Deviation 2.78 |
Secondary
Number of LCCs Smoked in Past Day
The mean number of little cigars and cigarillos (LCCs) smoked in the past day reported by participant
Time frame: day 6
Population: Participants who responded to the measures at the time point of interest, day 6
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Newly Developed Warnings With Images | Number of LCCs Smoked in Past Day | 2.66 number of LCCs | Standard Deviation 3.72 |
| FDA Proposed Text-only Warnings | Number of LCCs Smoked in Past Day | 3.12 number of LCCs | Standard Deviation 4.81 |
| Control Group, no Intervention | Number of LCCs Smoked in Past Day | 2.20 number of LCCs | Standard Deviation 2.64 |
Secondary
Number of LCCs Smoked in Past Day
The mean number of little cigars and cigarillos (LCCs) smoked in the past day reported by participant
Time frame: day 7
Population: Participants who responded to the measures at the time point of interest, day 7
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Newly Developed Warnings With Images | Number of LCCs Smoked in Past Day | 2.30 number of LCCs | Standard Deviation 3.18 |
| FDA Proposed Text-only Warnings | Number of LCCs Smoked in Past Day | 2.73 number of LCCs | Standard Deviation 4.04 |
| Control Group, no Intervention | Number of LCCs Smoked in Past Day | 2.33 number of LCCs | Standard Deviation 3.49 |
Secondary
Number of LCCs Smoked in Past Day
The mean number of little cigars and cigarillos (LCCs) smoked in the past day reported by participant
Time frame: day 8
Population: Participants who responded to the measures at the time point of interest, day 8
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Newly Developed Warnings With Images | Number of LCCs Smoked in Past Day | 2.37 number of LCCs | Standard Deviation 3.61 |
| FDA Proposed Text-only Warnings | Number of LCCs Smoked in Past Day | 2.68 number of LCCs | Standard Deviation 4.46 |
| Control Group, no Intervention | Number of LCCs Smoked in Past Day | 2.28 number of LCCs | Standard Deviation 3.13 |
Secondary
Number of LCCs Smoked in Past Day
The mean number of little cigars and cigarillos (LCCs) smoked in the past day reported by participant
Time frame: day 9
Population: Participants who responded to the measures at the time point of interest, day 9
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Newly Developed Warnings With Images | Number of LCCs Smoked in Past Day | 2.64 number of LCCs | Standard Deviation 4.28 |
| FDA Proposed Text-only Warnings | Number of LCCs Smoked in Past Day | 2.68 number of LCCs | Standard Deviation 4.5 |
| Control Group, no Intervention | Number of LCCs Smoked in Past Day | 2.43 number of LCCs | Standard Deviation 3.27 |
Secondary
Number of LCCs Smoked in Past Day
The mean number of little cigars and cigarillos (LCCs) smoked in the past day reported by participant
Time frame: day 10
Population: Participants who responded to the measures at the time point of interest, day 10
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Newly Developed Warnings With Images | Number of LCCs Smoked in Past Day | 2.62 number of LCCs | Standard Deviation 4.5 |
| FDA Proposed Text-only Warnings | Number of LCCs Smoked in Past Day | 2.56 number of LCCs | Standard Deviation 4.16 |
| Control Group, no Intervention | Number of LCCs Smoked in Past Day | 2.39 number of LCCs | Standard Deviation 3.27 |
Secondary
Number of LCCs Smoked in Past Day
The mean number of little cigars and cigarillos (LCCs) smoked in the past day reported by participant
Time frame: day 11
Population: Participants who responded to the measures at the time point of interest, day 11
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Newly Developed Warnings With Images | Number of LCCs Smoked in Past Day | 2.69 number of LCCs | Standard Deviation 4.11 |
| FDA Proposed Text-only Warnings | Number of LCCs Smoked in Past Day | 2.94 number of LCCs | Standard Deviation 4.47 |
| Control Group, no Intervention | Number of LCCs Smoked in Past Day | 2.47 number of LCCs | Standard Deviation 3.23 |
Secondary
Number of LCCs Smoked in Past Day
The mean number of little cigars and cigarillos (LCCs) smoked in the past day reported by participant
Time frame: day 12
Population: Participants who responded to the measures at the time point of interest, day 12
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Newly Developed Warnings With Images | Number of LCCs Smoked in Past Day | 2.28 number of LCCs | Standard Deviation 3.28 |
| FDA Proposed Text-only Warnings | Number of LCCs Smoked in Past Day | 2.77 number of LCCs | Standard Deviation 4.33 |
| Control Group, no Intervention | Number of LCCs Smoked in Past Day | 2.46 number of LCCs | Standard Deviation 3.01 |
Secondary
Number of LCCs Smoked in the Past Week
The mean number of little cigars and cigarillos (LCCs) smoked in the past week reported by participant
Time frame: day 21 (post test)
Population: Participants who responded to the measures at the time point of interest, day 21 (post test)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Newly Developed Warnings With Images | Number of LCCs Smoked in the Past Week | 14.11 number of LCCs | Standard Deviation 20.3 |
| FDA Proposed Text-only Warnings | Number of LCCs Smoked in the Past Week | 15.89 number of LCCs | Standard Deviation 22.38 |
| Control Group, no Intervention | Number of LCCs Smoked in the Past Week | 13.93 number of LCCs | Standard Deviation 18.94 |
Secondary
Number of LCCs Smoked in the Past Week
The mean number of little cigars and cigarillos (LCCs) smoked in the past week reported by participant
Time frame: day 14
Population: Participants who responded to the measures at the time point of interest, day 14
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Newly Developed Warnings With Images | Number of LCCs Smoked in the Past Week | 14.67 number of LCCs | Standard Deviation 22.45 |
| FDA Proposed Text-only Warnings | Number of LCCs Smoked in the Past Week | 15.35 number of LCCs | Standard Deviation 22.37 |
| Control Group, no Intervention | Number of LCCs Smoked in the Past Week | 13.47 number of LCCs | Standard Deviation 18.03 |
Secondary
Number of LCCs Smoked in the Past Week
The mean number of little cigars and cigarillos (LCCs) smoked in the past week reported by participant
Time frame: day 7
Population: Participants who responded to the measures at the time point of interest, day 7
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Newly Developed Warnings With Images | Number of LCCs Smoked in the Past Week | 15.66 number of LCCs | Standard Deviation 23.13 |
| FDA Proposed Text-only Warnings | Number of LCCs Smoked in the Past Week | 16.05 number of LCCs | Standard Deviation 24.84 |
| Control Group, no Intervention | Number of LCCs Smoked in the Past Week | 13.32 number of LCCs | Standard Deviation 17.32 |
Secondary
Self Reported Learning
Mean self-reported learning reported by participants. Self-reported learning measured with one item on a 1 to 5 scale, where 1 indicates no learning, and 5 indicates a great deal of learning from the warnings in the study. Self reported learning is only measured in conditions 1 and 2, the conditions that receive warnings.
Time frame: day 21 (post test)
Population: Only Newly developed warnings with images and FDA proposed text-only warnings were included. Participants who responded to the measures at the time point of interest, day 21 (post test)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Newly Developed Warnings With Images | Self Reported Learning | 4.14 units on a scale | Standard Deviation 1.01 |
| FDA Proposed Text-only Warnings | Self Reported Learning | 3.60 units on a scale | Standard Deviation 1.18 |