Trial Outcomes & Findings for Little Cigar and Cigarillo Warnings Among US Adults Who Use LCCs (NCT NCT05849051)
NCT ID: NCT05849051
Last Updated: 2025-01-08
Results Overview
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.
COMPLETED
NA
1029 participants
day 21 (post test)
2025-01-08
Participant Flow
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.
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.
Participant milestones
| Measure |
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.
|
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.
|
Control Group, no Intervention
Participants do not receive an intervention
|
|---|---|---|---|
|
Overall Study
STARTED
|
339
|
346
|
344
|
|
Overall Study
COMPLETED
|
339
|
346
|
344
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Little Cigar and Cigarillo Warnings Among US Adults Who Use LCCs
Baseline characteristics by cohort
| Measure |
Newly Developed Warnings With Images
n=339 Participants
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.
|
FDA Proposed Text-only Warnings
n=346 Participants
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.
|
Control Group, no Intervention
n=344 Participants
Participants do not receive an intervention
|
Total
n=1029 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
43.03 years
STANDARD_DEVIATION 10.44 • n=5 Participants
|
44.48 years
STANDARD_DEVIATION 11.73 • n=7 Participants
|
44.07 years
STANDARD_DEVIATION 11.61 • n=5 Participants
|
43.86 years
STANDARD_DEVIATION 11.29 • n=4 Participants
|
|
Sex/Gender, Customized
Male
|
175 Participants
n=5 Participants
|
208 Participants
n=7 Participants
|
195 Participants
n=5 Participants
|
578 Participants
n=4 Participants
|
|
Sex/Gender, Customized
Female
|
163 Participants
n=5 Participants
|
138 Participants
n=7 Participants
|
148 Participants
n=5 Participants
|
449 Participants
n=4 Participants
|
|
Sex/Gender, Customized
Another Gender
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
68 Participants
n=5 Participants
|
50 Participants
n=7 Participants
|
52 Participants
n=5 Participants
|
170 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
270 Participants
n=5 Participants
|
294 Participants
n=7 Participants
|
291 Participants
n=5 Participants
|
855 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaska Native
|
5 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
10 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Asian
|
21 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
53 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian/Pacific Islander
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Black/African American
|
70 Participants
n=5 Participants
|
70 Participants
n=7 Participants
|
77 Participants
n=5 Participants
|
217 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
White
|
203 Participants
n=5 Participants
|
228 Participants
n=7 Participants
|
214 Participants
n=5 Participants
|
645 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
More than one Race
|
24 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
65 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Unknown not reported
|
16 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
37 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
339 participants
n=5 Participants
|
346 participants
n=7 Participants
|
344 participants
n=5 Participants
|
1029 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: day 21 (post test)Population: Participants who responded to the scale at the time point of interest, post test on day 21
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.
Outcome measures
| Measure |
Newly Developed Warnings With Images
n=311 Participants
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.
|
FDA Proposed Text-only Warnings
n=317 Participants
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.
|
Control Group, no Intervention
n=312 Participants
Participants do not receive an intervention
|
|---|---|---|---|
|
LCC Quit Intentions
|
2.9 score on a scale
Standard Deviation 1.10
|
2.49 score on a scale
Standard Deviation 1.12
|
2.54 score on a scale
Standard Deviation 1.09
|
SECONDARY outcome
Timeframe: day 1Population: Participants who responded to the measures at the time point of interest, day 1
The mean number of little cigars and cigarillos (LCCs) smoked in the past day reported by participant.
Outcome measures
| Measure |
Newly Developed Warnings With Images
n=264 Participants
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.
|
FDA Proposed Text-only Warnings
n=268 Participants
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.
|
Control Group, no Intervention
n=255 Participants
Participants do not receive an intervention
|
|---|---|---|---|
|
Number of LCCs Smoked in Past Day
|
2.75 number of LCCs
Standard Deviation 4.09
|
2.47 number of LCCs
Standard Deviation 3.14
|
2.28 number of LCCs
Standard Deviation 2.85
|
SECONDARY outcome
Timeframe: day 2Population: Participants who responded to the measures at the time point of interest, day 2
The mean number of little cigars and cigarillos (LCCs) smoked in the past day reported by participant
Outcome measures
| Measure |
Newly Developed Warnings With Images
n=268 Participants
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.
|
FDA Proposed Text-only Warnings
n=271 Participants
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.
|
Control Group, no Intervention
n=278 Participants
Participants do not receive an intervention
|
|---|---|---|---|
|
Number of LCCs Smoked in Past Day
|
2.43 number of LCCs
Standard Deviation 3.09
|
2.62 number of LCCs
Standard Deviation 3.30
|
2.21 number of LCCs
Standard Deviation 2.79
|
SECONDARY outcome
Timeframe: day 3Population: Participants who responded to the measures at the time point of interest, day 3
The mean number of little cigars and cigarillos (LCCs) smoked in the past day was reported by participants.
Outcome measures
| Measure |
Newly Developed Warnings With Images
n=279 Participants
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.
|
FDA Proposed Text-only Warnings
n=258 Participants
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.
|
Control Group, no Intervention
n=264 Participants
Participants do not receive an intervention
|
|---|---|---|---|
|
Number of LCCs Smoked in Past Day
|
2.56 number of LCCs
Standard Deviation 3.17
|
2.66 number of LCCs
Standard Deviation 3.13
|
2.44 number of LCCs
Standard Deviation 2.86
|
SECONDARY outcome
Timeframe: day 4Population: Participants who responded to the measures at the time point of interest, day 4
The mean number of little cigars and cigarillos (LCCs) smoked in the past day reported by participant.
Outcome measures
| Measure |
Newly Developed Warnings With Images
n=275 Participants
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.
|
FDA Proposed Text-only Warnings
n=294 Participants
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.
|
Control Group, no Intervention
n=289 Participants
Participants do not receive an intervention
|
|---|---|---|---|
|
Number of LCCs Smoked in Past Day
|
2.66 number of LCCs
Standard Deviation 3.51
|
3.04 number of LCCs
Standard Deviation 4.46
|
2.50 number of LCCs
Standard Deviation 2.95
|
SECONDARY outcome
Timeframe: day 5Population: Participants who responded to the measures at the time point of interest, day 5
The mean number of little cigars and cigarillos (LCCs) smoked in the past day reported by participant
Outcome measures
| Measure |
Newly Developed Warnings With Images
n=283 Participants
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.
|
FDA Proposed Text-only Warnings
n=282 Participants
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.
|
Control Group, no Intervention
n=273 Participants
Participants do not receive an intervention
|
|---|---|---|---|
|
Number of LCCs Smoked in Past Day
|
2.77 number of LCCs
Standard Deviation 3.67
|
3.07 number of LCCs
Standard Deviation 4.21
|
2.43 number of LCCs
Standard Deviation 2.78
|
SECONDARY outcome
Timeframe: day 6Population: Participants who responded to the measures at the time point of interest, day 6
The mean number of little cigars and cigarillos (LCCs) smoked in the past day reported by participant
Outcome measures
| Measure |
Newly Developed Warnings With Images
n=295 Participants
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.
|
FDA Proposed Text-only Warnings
n=301 Participants
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.
|
Control Group, no Intervention
n=291 Participants
Participants do not receive an intervention
|
|---|---|---|---|
|
Number of LCCs Smoked in Past Day
|
2.66 number of LCCs
Standard Deviation 3.72
|
3.12 number of LCCs
Standard Deviation 4.81
|
2.20 number of LCCs
Standard Deviation 2.64
|
SECONDARY outcome
Timeframe: day 7Population: Participants who responded to the measures at the time point of interest, day 7
The mean number of little cigars and cigarillos (LCCs) smoked in the past day reported by participant
Outcome measures
| Measure |
Newly Developed Warnings With Images
n=298 Participants
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.
|
FDA Proposed Text-only Warnings
n=299 Participants
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.
|
Control Group, no Intervention
n=293 Participants
Participants do not receive an intervention
|
|---|---|---|---|
|
Number of LCCs Smoked in Past Day
|
2.30 number of LCCs
Standard Deviation 3.18
|
2.73 number of LCCs
Standard Deviation 4.04
|
2.33 number of LCCs
Standard Deviation 3.49
|
SECONDARY outcome
Timeframe: day 8Population: Participants who responded to the measures at the time point of interest, day 8
The mean number of little cigars and cigarillos (LCCs) smoked in the past day reported by participant
Outcome measures
| Measure |
Newly Developed Warnings With Images
n=294 Participants
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.
|
FDA Proposed Text-only Warnings
n=299 Participants
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.
|
Control Group, no Intervention
n=294 Participants
Participants do not receive an intervention
|
|---|---|---|---|
|
Number of LCCs Smoked in Past Day
|
2.37 number of LCCs
Standard Deviation 3.61
|
2.68 number of LCCs
Standard Deviation 4.46
|
2.28 number of LCCs
Standard Deviation 3.13
|
SECONDARY outcome
Timeframe: day 9Population: Participants who responded to the measures at the time point of interest, day 9
The mean number of little cigars and cigarillos (LCCs) smoked in the past day reported by participant
Outcome measures
| Measure |
Newly Developed Warnings With Images
n=293 Participants
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.
|
FDA Proposed Text-only Warnings
n=292 Participants
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.
|
Control Group, no Intervention
n=298 Participants
Participants do not receive an intervention
|
|---|---|---|---|
|
Number of LCCs Smoked in Past Day
|
2.64 number of LCCs
Standard Deviation 4.28
|
2.68 number of LCCs
Standard Deviation 4.50
|
2.43 number of LCCs
Standard Deviation 3.27
|
SECONDARY outcome
Timeframe: day 10Population: Participants who responded to the measures at the time point of interest, day 10
The mean number of little cigars and cigarillos (LCCs) smoked in the past day reported by participant
Outcome measures
| Measure |
Newly Developed Warnings With Images
n=284 Participants
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.
|
FDA Proposed Text-only Warnings
n=298 Participants
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.
|
Control Group, no Intervention
n=284 Participants
Participants do not receive an intervention
|
|---|---|---|---|
|
Number of LCCs Smoked in Past Day
|
2.62 number of LCCs
Standard Deviation 4.50
|
2.56 number of LCCs
Standard Deviation 4.16
|
2.39 number of LCCs
Standard Deviation 3.27
|
SECONDARY outcome
Timeframe: day 11Population: Participants who responded to the measures at the time point of interest, day 11
The mean number of little cigars and cigarillos (LCCs) smoked in the past day reported by participant
Outcome measures
| Measure |
Newly Developed Warnings With Images
n=280 Participants
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.
|
FDA Proposed Text-only Warnings
n=288 Participants
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.
|
Control Group, no Intervention
n=284 Participants
Participants do not receive an intervention
|
|---|---|---|---|
|
Number of LCCs Smoked in Past Day
|
2.69 number of LCCs
Standard Deviation 4.11
|
2.94 number of LCCs
Standard Deviation 4.47
|
2.47 number of LCCs
Standard Deviation 3.23
|
SECONDARY outcome
Timeframe: day 12Population: Participants who responded to the measures at the time point of interest, day 12
The mean number of little cigars and cigarillos (LCCs) smoked in the past day reported by participant
Outcome measures
| Measure |
Newly Developed Warnings With Images
n=285 Participants
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.
|
FDA Proposed Text-only Warnings
n=293 Participants
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.
|
Control Group, no Intervention
n=284 Participants
Participants do not receive an intervention
|
|---|---|---|---|
|
Number of LCCs Smoked in Past Day
|
2.28 number of LCCs
Standard Deviation 3.28
|
2.77 number of LCCs
Standard Deviation 4.33
|
2.46 number of LCCs
Standard Deviation 3.01
|
SECONDARY outcome
Timeframe: day 13Population: Participants who responded to the measures at the time point of interest, day 13
The mean number of little cigars and cigarillos (LCCs) smoked in the past day reported by participant
Outcome measures
| Measure |
Newly Developed Warnings With Images
n=291 Participants
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.
|
FDA Proposed Text-only Warnings
n=297 Participants
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.
|
Control Group, no Intervention
n=295 Participants
Participants do not receive an intervention
|
|---|---|---|---|
|
Number of LCCs Smoked in Past Day
|
2.62 number of LCCs
Standard Deviation 3.86
|
2.79 number of LCCs
Standard Deviation 4.61
|
2.50 number of LCCs
Standard Deviation 3.38
|
SECONDARY outcome
Timeframe: day 14Population: Participants who responded to the measures at the time point of interest, day 14
The mean number of little cigars and cigarillos (LCCs) smoked in the past day reported by participant
Outcome measures
| Measure |
Newly Developed Warnings With Images
n=278 Participants
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.
|
FDA Proposed Text-only Warnings
n=293 Participants
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.
|
Control Group, no Intervention
n=288 Participants
Participants do not receive an intervention
|
|---|---|---|---|
|
Number of LCCs Smoked in Past Day
|
2.19 number of LCCs
Standard Deviation 3.24
|
2.44 number of LCCs
Standard Deviation 4.58
|
2.24 number of LCCs
Standard Deviation 3.47
|
SECONDARY outcome
Timeframe: day 15Population: Participants who responded to the measures at the time point of interest, day 15
The mean number of little cigars and cigarillos (LCCs) smoked in the past day reported by participant
Outcome measures
| Measure |
Newly Developed Warnings With Images
n=268 Participants
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.
|
FDA Proposed Text-only Warnings
n=274 Participants
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.
|
Control Group, no Intervention
n=267 Participants
Participants do not receive an intervention
|
|---|---|---|---|
|
Number of LCCs Smoked in Past Day
|
2.35 number of LCCs
Standard Deviation 4.27
|
2.56 number of LCCs
Standard Deviation 4.46
|
2.26 number of LCCs
Standard Deviation 3.39
|
SECONDARY outcome
Timeframe: day 16Population: Participants who responded to the measures at the time point of interest, day 16
The mean number of little cigars and cigarillos (LCCs) smoked in the past day reported by participant
Outcome measures
| Measure |
Newly Developed Warnings With Images
n=274 Participants
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.
|
FDA Proposed Text-only Warnings
n=290 Participants
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.
|
Control Group, no Intervention
n=283 Participants
Participants do not receive an intervention
|
|---|---|---|---|
|
Number of LCCs Smoked in Past Day
|
2.21 number of LCCs
Standard Deviation 3.07
|
2.62 number of LCCs
Standard Deviation 4.43
|
2.35 number of LCCs
Standard Deviation 3.57
|
SECONDARY outcome
Timeframe: day 17Population: Participants who responded to the measures at the time point of interest, day 17
The mean number of little cigars and cigarillos (LCCs) smoked in the past day reported by participant
Outcome measures
| Measure |
Newly Developed Warnings With Images
n=279 Participants
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.
|
FDA Proposed Text-only Warnings
n=290 Participants
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.
|
Control Group, no Intervention
n=286 Participants
Participants do not receive an intervention
|
|---|---|---|---|
|
Number of LCCs Smoked in Past Day
|
2.23 number of LCCs
Standard Deviation 3.38
|
2.62 number of LCCs
Standard Deviation 4.35
|
2.38 number of LCCs
Standard Deviation 3.58
|
SECONDARY outcome
Timeframe: day 18Population: Participants who responded to the measures at the time point of interest, day 18
The mean number of little cigars and cigarillos (LCCs) smoked in the past day reported by participant
Outcome measures
| Measure |
Newly Developed Warnings With Images
n=279 Participants
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.
|
FDA Proposed Text-only Warnings
n=277 Participants
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.
|
Control Group, no Intervention
n=272 Participants
Participants do not receive an intervention
|
|---|---|---|---|
|
Number of LCCs Smoked in Past Day
|
2.26 number of LCCs
Standard Deviation 3.33
|
2.87 number of LCCs
Standard Deviation 4.51
|
2.47 number of LCCs
Standard Deviation 3.36
|
SECONDARY outcome
Timeframe: day 19Population: Participants who responded to the measures at the time point of interest, day 19
The mean number of little cigars and cigarillos (LCCs) smoked in the past day reported by participant
Outcome measures
| Measure |
Newly Developed Warnings With Images
n=273 Participants
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.
|
FDA Proposed Text-only Warnings
n=289 Participants
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.
|
Control Group, no Intervention
n=284 Participants
Participants do not receive an intervention
|
|---|---|---|---|
|
Number of LCCs Smoked in Past Day
|
2.27 number of LCCs
Standard Deviation 3.38
|
2.85 number of LCCs
Standard Deviation 4.36
|
2.38 number of LCCs
Standard Deviation 3.39
|
SECONDARY outcome
Timeframe: day 20Population: Participants who responded to the measures at the time point of interest, day 20
The mean number of little cigars and cigarillos (LCCs) smoked in the past day reported by participant
Outcome measures
| Measure |
Newly Developed Warnings With Images
n=288 Participants
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.
|
FDA Proposed Text-only Warnings
n=289 Participants
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.
|
Control Group, no Intervention
n=283 Participants
Participants do not receive an intervention
|
|---|---|---|---|
|
Number of LCCs Smoked in Past Day
|
2.18 number of LCCs
Standard Deviation 3.46
|
2.62 number of LCCs
Standard Deviation 4.25
|
2.36 number of LCCs
Standard Deviation 3.40
|
SECONDARY outcome
Timeframe: day 21 (post test)Population: Participants who responded to the measures at the time point of interest, day 21 (post test)
The mean number of little cigars and cigarillos (LCCs) smoked in the past day reported by participant
Outcome measures
| Measure |
Newly Developed Warnings With Images
n=305 Participants
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.
|
FDA Proposed Text-only Warnings
n=311 Participants
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.
|
Control Group, no Intervention
n=306 Participants
Participants do not receive an intervention
|
|---|---|---|---|
|
Number of LCCs Smoked in Past Day
|
2.13 number of LCCs
Standard Deviation 3.30
|
2.34 number of LCCs
Standard Deviation 3.36
|
2.43 number of LCCs
Standard Deviation 4.58
|
SECONDARY outcome
Timeframe: day 7Population: Participants who responded to the measures at the time point of interest, day 7
The mean number days that a participant reported smoking little cigars and cigarillos (LCCs) smoked in the past week
Outcome measures
| Measure |
Newly Developed Warnings With Images
n=307 Participants
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.
|
FDA Proposed Text-only Warnings
n=305 Participants
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.
|
Control Group, no Intervention
n=302 Participants
Participants do not receive an intervention
|
|---|---|---|---|
|
Number of Days Smoked LCCs in Past Week
|
3.46 number of days
Standard Deviation 2.29
|
3.58 number of days
Standard Deviation 2.31
|
3.46 number of days
Standard Deviation 2.25
|
SECONDARY outcome
Timeframe: day 14Population: Participants who responded to the measures at the time point of interest, day 14
The mean number days that a participant reported smoking little cigars and cigarillos (LCCs) smoked in the past week
Outcome measures
| Measure |
Newly Developed Warnings With Images
n=286 Participants
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.
|
FDA Proposed Text-only Warnings
n=300 Participants
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.
|
Control Group, no Intervention
n=295 Participants
Participants do not receive an intervention
|
|---|---|---|---|
|
Number of Days Smoked LCCs in Past Week
|
3.26 number of days
Standard Deviation 2.40
|
3.50 number of days
Standard Deviation 2.38
|
3.45 number of days
Standard Deviation 2.28
|
SECONDARY outcome
Timeframe: day 21 (post test)Population: Participants who responded to the measures at the time point of interest, day 21 (post test)
The mean number days that a participant reported smoking little cigars and cigarillos (LCCs) smoked in the past week
Outcome measures
| Measure |
Newly Developed Warnings With Images
n=312 Participants
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.
|
FDA Proposed Text-only Warnings
n=317 Participants
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.
|
Control Group, no Intervention
n=313 Participants
Participants do not receive an intervention
|
|---|---|---|---|
|
Number of Days Smoked LCCs in Past Week
|
3.15 number of days
Standard Deviation 2.44
|
3.46 number of days
Standard Deviation 2.47
|
3.41 number of days
Standard Deviation 2.29
|
SECONDARY outcome
Timeframe: day 7Population: Participants who responded to the measures at the time point of interest, day 7
The mean number of little cigars and cigarillos (LCCs) smoked in the past week reported by participant
Outcome measures
| Measure |
Newly Developed Warnings With Images
n=307 Participants
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.
|
FDA Proposed Text-only Warnings
n=305 Participants
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.
|
Control Group, no Intervention
n=302 Participants
Participants do not receive an intervention
|
|---|---|---|---|
|
Number of LCCs Smoked in the Past Week
|
15.66 number of LCCs
Standard Deviation 23.13
|
16.05 number of LCCs
Standard Deviation 24.84
|
13.32 number of LCCs
Standard Deviation 17.32
|
SECONDARY outcome
Timeframe: day 14Population: Participants who responded to the measures at the time point of interest, day 14
The mean number of little cigars and cigarillos (LCCs) smoked in the past week reported by participant
Outcome measures
| Measure |
Newly Developed Warnings With Images
n=286 Participants
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.
|
FDA Proposed Text-only Warnings
n=300 Participants
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.
|
Control Group, no Intervention
n=295 Participants
Participants do not receive an intervention
|
|---|---|---|---|
|
Number of LCCs Smoked in the Past Week
|
14.67 number of LCCs
Standard Deviation 22.45
|
15.35 number of LCCs
Standard Deviation 22.37
|
13.47 number of LCCs
Standard Deviation 18.03
|
SECONDARY outcome
Timeframe: day 21 (post test)Population: Participants who responded to the measures at the time point of interest, day 21 (post test)
The mean number of little cigars and cigarillos (LCCs) smoked in the past week reported by participant
Outcome measures
| Measure |
Newly Developed Warnings With Images
n=311 Participants
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.
|
FDA Proposed Text-only Warnings
n=317 Participants
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.
|
Control Group, no Intervention
n=313 Participants
Participants do not receive an intervention
|
|---|---|---|---|
|
Number of LCCs Smoked in the Past Week
|
14.11 number of LCCs
Standard Deviation 20.30
|
15.89 number of LCCs
Standard Deviation 22.38
|
13.93 number of LCCs
Standard Deviation 18.94
|
SECONDARY outcome
Timeframe: day 7Population: Participants who responded to the measures at the time point of interest, day 7
The mean number of little cigars and cigarillos (LCCs) that participants reported butting out in the past week
Outcome measures
| Measure |
Newly Developed Warnings With Images
n=300 Participants
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.
|
FDA Proposed Text-only Warnings
n=298 Participants
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.
|
Control Group, no Intervention
n=293 Participants
Participants do not receive an intervention
|
|---|---|---|---|
|
Number of LCCs Butted Out in the Past Week
|
4.24 number of LCCs
Standard Deviation 7.86
|
3.64 number of LCCs
Standard Deviation 18.09
|
3.03 number of LCCs
Standard Deviation 6.51
|
SECONDARY outcome
Timeframe: day 14Population: Participants who responded to the measures at the time point of interest, day 14
The mean number of little cigars and cigarillos (LCCs) that participants reported butting out in the past week
Outcome measures
| Measure |
Newly Developed Warnings With Images
n=276 Participants
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.
|
FDA Proposed Text-only Warnings
n=295 Participants
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.
|
Control Group, no Intervention
n=287 Participants
Participants do not receive an intervention
|
|---|---|---|---|
|
Number of LCCs Butted Out in the Past Week
|
3.11 number of LCCs
Standard Deviation 5.22
|
3.48 number of LCCs
Standard Deviation 15.53
|
2.59 number of LCCs
Standard Deviation 5.71
|
SECONDARY outcome
Timeframe: day 21 (post test)Population: Participants who responded to the measures at the time point of interest, day 21 (post test)
The mean number of little cigars and cigarillos (LCCs) that participants reported butting out in the past week
Outcome measures
| Measure |
Newly Developed Warnings With Images
n=304 Participants
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.
|
FDA Proposed Text-only Warnings
n=311 Participants
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.
|
Control Group, no Intervention
n=305 Participants
Participants do not receive an intervention
|
|---|---|---|---|
|
Number of LCCs Butted Out in the Past Week
|
3.11 number of LCCs
Standard Deviation 5.41
|
3.46 number of LCCs
Standard Deviation 14.93
|
2.81 number of LCCs
Standard Deviation 5.67
|
SECONDARY outcome
Timeframe: day 7Population: Participants who responded to the measures at the time point of interest, day 7
The mean number of little cigars and cigarillos (LCCs) that participants reported forgoing in the past week
Outcome measures
| Measure |
Newly Developed Warnings With Images
n=307 Participants
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.
|
FDA Proposed Text-only Warnings
n=305 Participants
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.
|
Control Group, no Intervention
n=302 Participants
Participants do not receive an intervention
|
|---|---|---|---|
|
Number of LCCs Forgone in the Past Week
|
3.85 number of LCCs
Standard Deviation 5.24
|
3.64 number of LCCs
Standard Deviation 17.62
|
2.88 number of LCCs
Standard Deviation 4.83
|
SECONDARY outcome
Timeframe: day 14Population: Participants who responded to the measures at the time point of interest, day 14
The mean number of little cigars and cigarillos (LCCs) that participants reported forgoing in the past week
Outcome measures
| Measure |
Newly Developed Warnings With Images
n=286 Participants
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.
|
FDA Proposed Text-only Warnings
n=300 Participants
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.
|
Control Group, no Intervention
n=295 Participants
Participants do not receive an intervention
|
|---|---|---|---|
|
Number of LCCs Forgone in the Past Week
|
6.79 number of LCCs
Standard Deviation 30.85
|
3.47 number of LCCs
Standard Deviation 15.39
|
2.81 number of LCCs
Standard Deviation 4.31
|
SECONDARY outcome
Timeframe: day 21 (post test)Population: Participants who responded to the measures at the time point of interest, day 21 (post test)
The mean number of little cigars and cigarillos (LCCs) that participants reported forgoing in the past week
Outcome measures
| Measure |
Newly Developed Warnings With Images
n=311 Participants
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.
|
FDA Proposed Text-only Warnings
n=317 Participants
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.
|
Control Group, no Intervention
n=313 Participants
Participants do not receive an intervention
|
|---|---|---|---|
|
Number of LCCs Forgone in the Past Week
|
5.69 number of LCCs
Standard Deviation 14.67
|
4.30 number of LCCs
Standard Deviation 15.95
|
3.46 number of LCCs
Standard Deviation 7.30
|
SECONDARY outcome
Timeframe: day 7Population: Participants who responded to the measures at the time point of interest, day 7
The number and percent of participants who reported trying to quit smoking little cigars and cigarillos (LCCs) in the past week
Outcome measures
| Measure |
Newly Developed Warnings With Images
n=307 Participants
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.
|
FDA Proposed Text-only Warnings
n=305 Participants
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.
|
Control Group, no Intervention
n=301 Participants
Participants do not receive an intervention
|
|---|---|---|---|
|
LCC Quit Attempts in Past Week
|
108 Participants
|
61 Participants
|
62 Participants
|
SECONDARY outcome
Timeframe: day 14Population: Participants who responded to the measures at the time point of interest, day 14
The number and percent of participants who reported trying to quit smoking little cigars and cigarillos (LCCs) in the past week
Outcome measures
| Measure |
Newly Developed Warnings With Images
n=286 Participants
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.
|
FDA Proposed Text-only Warnings
n=299 Participants
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.
|
Control Group, no Intervention
n=295 Participants
Participants do not receive an intervention
|
|---|---|---|---|
|
LCC Quit Attempts in Past Week
|
102 Participants
|
71 Participants
|
66 Participants
|
SECONDARY outcome
Timeframe: day 21 (post test)Population: Participants who responded to the measures at the time point of interest, day 21 (post test)
The number and percent of participants who reported trying to quit smoking little cigars and cigarillos (LCCs) in the past week
Outcome measures
| Measure |
Newly Developed Warnings With Images
n=311 Participants
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.
|
FDA Proposed Text-only Warnings
n=317 Participants
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.
|
Control Group, no Intervention
n=312 Participants
Participants do not receive an intervention
|
|---|---|---|---|
|
LCC Quit Attempts in Past Week
|
134 Participants
|
90 Participants
|
86 Participants
|
SECONDARY outcome
Timeframe: day 7Population: Participants who responded to the scale at the time point of interest, 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.
Outcome measures
| Measure |
Newly Developed Warnings With Images
n=307 Participants
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.
|
FDA Proposed Text-only Warnings
n=305 Participants
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.
|
Control Group, no Intervention
n=301 Participants
Participants do not receive an intervention
|
|---|---|---|---|
|
LCC Quit Intentions
|
2.76 score on a scale
Standard Deviation 1.07
|
2.33 score on a scale
Standard Deviation 1.05
|
2.46 score on a scale
Standard Deviation 1.04
|
SECONDARY outcome
Timeframe: day 14Population: Participants who responded to the scale at the time point of interest, day 14
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.
Outcome measures
| Measure |
Newly Developed Warnings With Images
n=286 Participants
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.
|
FDA Proposed Text-only Warnings
n=299 Participants
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.
|
Control Group, no Intervention
n=295 Participants
Participants do not receive an intervention
|
|---|---|---|---|
|
LCC Quit Intentions
|
2.82 score on a scale
Standard Deviation 1.08
|
2.42 score on a scale
Standard Deviation 1.09
|
2.51 score on a scale
Standard Deviation 1.04
|
SECONDARY outcome
Timeframe: 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)
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.
Outcome measures
| Measure |
Newly Developed Warnings With Images
n=311 Participants
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.
|
FDA Proposed Text-only Warnings
n=316 Participants
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.
|
Control Group, no Intervention
Participants do not receive an intervention
|
|---|---|---|---|
|
Self Reported Learning
|
4.14 units on a scale
Standard Deviation 1.01
|
3.60 units on a scale
Standard Deviation 1.18
|
—
|
Adverse Events
Newly Developed Warnings With Images
FDA Proposed Text-only Warnings
Control Group, no Intervention
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Adam O Goldstein
UNC Lineberger Comprehensive Cancer Center
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place