An interventional study of Newly developed warnings with images at 30% size and FDA proposed text-only warnings at 30% size in Tobacco Use, sponsored by UNC Lineberger Comprehensive Cancer Center. Completed at 1 site in United States. Open to participants aged 21 Years and older. Per ClinicalTrials.gov, last updated 2025-01-08.
Sponsored by UNC Lineberger Comprehensive Cancer Center · Not applicable, Interventional, and Prevention
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.
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
UNC Lineberger Comprehensive Cancer Center is the lead sponsor of 414 studies on the registry; 96 are open to participants now.
Of its 32 completed or terminated interventional studies of FDA-regulated products, 25 (78%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Participants receive newly developed warnings intervention
Behavioral: Newly developed warnings with images at 30% size
Participants receive FDA proposed text only warning intervention
Behavioral: FDA proposed text-only warnings at 30% size
Participants do not receive an intervention
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.
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.
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)
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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)
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
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
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)
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
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
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)
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
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
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)
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
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
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)
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
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
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)
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
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
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)
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.
| Milestone | Newly Developed Warnings With Images | FDA Proposed Text-only Warnings | Control Group, no Intervention |
|---|---|---|---|
| Started | 339 | 346 | 344 |
| Completed | 339 | 346 | 344 |
| Not completed | 0 | 0 | 0 |
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.
| score on a scale | Newly Developed Warnings With Images | FDA Proposed Text-only Warnings | Control Group, no Intervention |
|---|---|---|---|
| LCC Quit Intentions | 2.9 ± 1.10 | 2.49 ± 1.12 | 2.54 ± 1.09 |
The mean number of little cigars and cigarillos (LCCs) smoked in the past day reported by participant.
| number of LCCs | Newly Developed Warnings With Images | FDA Proposed Text-only Warnings | Control Group, no Intervention |
|---|---|---|---|
| Number of LCCs Smoked in Past Day | 2.75 ± 4.09 | 2.47 ± 3.14 | 2.28 ± 2.85 |
The mean number of little cigars and cigarillos (LCCs) smoked in the past day reported by participant
| number of LCCs | Newly Developed Warnings With Images | FDA Proposed Text-only Warnings | Control Group, no Intervention |
|---|---|---|---|
| Number of LCCs Smoked in Past Day | 2.43 ± 3.09 | 2.62 ± 3.30 | 2.21 ± 2.79 |
The mean number of little cigars and cigarillos (LCCs) smoked in the past day was reported by participants.
| number of LCCs | Newly Developed Warnings With Images | FDA Proposed Text-only Warnings | Control Group, no Intervention |
|---|---|---|---|
| Number of LCCs Smoked in Past Day | 2.56 ± 3.17 | 2.66 ± 3.13 | 2.44 ± 2.86 |
The mean number of little cigars and cigarillos (LCCs) smoked in the past day reported by participant.
| number of LCCs | Newly Developed Warnings With Images | FDA Proposed Text-only Warnings | Control Group, no Intervention |
|---|---|---|---|
| Number of LCCs Smoked in Past Day | 2.66 ± 3.51 | 3.04 ± 4.46 | 2.50 ± 2.95 |
The mean number of little cigars and cigarillos (LCCs) smoked in the past day reported by participant
| number of LCCs | Newly Developed Warnings With Images | FDA Proposed Text-only Warnings | Control Group, no Intervention |
|---|---|---|---|
| Number of LCCs Smoked in Past Day | 2.77 ± 3.67 | 3.07 ± 4.21 | 2.43 ± 2.78 |
The mean number of little cigars and cigarillos (LCCs) smoked in the past day reported by participant
| number of LCCs | Newly Developed Warnings With Images | FDA Proposed Text-only Warnings | Control Group, no Intervention |
|---|---|---|---|
| Number of LCCs Smoked in Past Day | 2.66 ± 3.72 | 3.12 ± 4.81 | 2.20 ± 2.64 |
The mean number of little cigars and cigarillos (LCCs) smoked in the past day reported by participant
| number of LCCs | Newly Developed Warnings With Images | FDA Proposed Text-only Warnings | Control Group, no Intervention |
|---|---|---|---|
| Number of LCCs Smoked in Past Day | 2.30 ± 3.18 | 2.73 ± 4.04 | 2.33 ± 3.49 |
The mean number of little cigars and cigarillos (LCCs) smoked in the past day reported by participant
| number of LCCs | Newly Developed Warnings With Images | FDA Proposed Text-only Warnings | Control Group, no Intervention |
|---|---|---|---|
| Number of LCCs Smoked in Past Day | 2.37 ± 3.61 | 2.68 ± 4.46 | 2.28 ± 3.13 |
The mean number of little cigars and cigarillos (LCCs) smoked in the past day reported by participant
| number of LCCs | Newly Developed Warnings With Images | FDA Proposed Text-only Warnings | Control Group, no Intervention |
|---|---|---|---|
| Number of LCCs Smoked in Past Day | 2.64 ± 4.28 | 2.68 ± 4.50 | 2.43 ± 3.27 |
The mean number of little cigars and cigarillos (LCCs) smoked in the past day reported by participant
| number of LCCs | Newly Developed Warnings With Images | FDA Proposed Text-only Warnings | Control Group, no Intervention |
|---|---|---|---|
| Number of LCCs Smoked in Past Day | 2.62 ± 4.50 | 2.56 ± 4.16 | 2.39 ± 3.27 |
The mean number of little cigars and cigarillos (LCCs) smoked in the past day reported by participant
| number of LCCs | Newly Developed Warnings With Images | FDA Proposed Text-only Warnings | Control Group, no Intervention |
|---|---|---|---|
| Number of LCCs Smoked in Past Day | 2.69 ± 4.11 | 2.94 ± 4.47 | 2.47 ± 3.23 |
The mean number of little cigars and cigarillos (LCCs) smoked in the past day reported by participant
| number of LCCs | Newly Developed Warnings With Images | FDA Proposed Text-only Warnings | Control Group, no Intervention |
|---|---|---|---|
| Number of LCCs Smoked in Past Day | 2.28 ± 3.28 | 2.77 ± 4.33 | 2.46 ± 3.01 |
The mean number of little cigars and cigarillos (LCCs) smoked in the past day reported by participant
| number of LCCs | Newly Developed Warnings With Images | FDA Proposed Text-only Warnings | Control Group, no Intervention |
|---|---|---|---|
| Number of LCCs Smoked in Past Day | 2.62 ± 3.86 | 2.79 ± 4.61 | 2.50 ± 3.38 |
The mean number of little cigars and cigarillos (LCCs) smoked in the past day reported by participant
| number of LCCs | Newly Developed Warnings With Images | FDA Proposed Text-only Warnings | Control Group, no Intervention |
|---|---|---|---|
| Number of LCCs Smoked in Past Day | 2.19 ± 3.24 | 2.44 ± 4.58 | 2.24 ± 3.47 |
The mean number of little cigars and cigarillos (LCCs) smoked in the past day reported by participant
| number of LCCs | Newly Developed Warnings With Images | FDA Proposed Text-only Warnings | Control Group, no Intervention |
|---|---|---|---|
| Number of LCCs Smoked in Past Day | 2.35 ± 4.27 | 2.56 ± 4.46 | 2.26 ± 3.39 |
The mean number of little cigars and cigarillos (LCCs) smoked in the past day reported by participant
| number of LCCs | Newly Developed Warnings With Images | FDA Proposed Text-only Warnings | Control Group, no Intervention |
|---|---|---|---|
| Number of LCCs Smoked in Past Day | 2.21 ± 3.07 | 2.62 ± 4.43 | 2.35 ± 3.57 |
The mean number of little cigars and cigarillos (LCCs) smoked in the past day reported by participant
| number of LCCs | Newly Developed Warnings With Images | FDA Proposed Text-only Warnings | Control Group, no Intervention |
|---|---|---|---|
| Number of LCCs Smoked in Past Day | 2.23 ± 3.38 | 2.62 ± 4.35 | 2.38 ± 3.58 |
The mean number of little cigars and cigarillos (LCCs) smoked in the past day reported by participant
| number of LCCs | Newly Developed Warnings With Images | FDA Proposed Text-only Warnings | Control Group, no Intervention |
|---|---|---|---|
| Number of LCCs Smoked in Past Day | 2.26 ± 3.33 | 2.87 ± 4.51 | 2.47 ± 3.36 |
The mean number of little cigars and cigarillos (LCCs) smoked in the past day reported by participant
| number of LCCs | Newly Developed Warnings With Images | FDA Proposed Text-only Warnings | Control Group, no Intervention |
|---|---|---|---|
| Number of LCCs Smoked in Past Day | 2.27 ± 3.38 | 2.85 ± 4.36 | 2.38 ± 3.39 |
The mean number of little cigars and cigarillos (LCCs) smoked in the past day reported by participant
| number of LCCs | Newly Developed Warnings With Images | FDA Proposed Text-only Warnings | Control Group, no Intervention |
|---|---|---|---|
| Number of LCCs Smoked in Past Day | 2.18 ± 3.46 | 2.62 ± 4.25 | 2.36 ± 3.40 |
The mean number of little cigars and cigarillos (LCCs) smoked in the past day reported by participant
| number of LCCs | Newly Developed Warnings With Images | FDA Proposed Text-only Warnings | Control Group, no Intervention |
|---|---|---|---|
| Number of LCCs Smoked in Past Day | 2.13 ± 3.30 | 2.34 ± 3.36 | 2.43 ± 4.58 |
The mean number days that a participant reported smoking little cigars and cigarillos (LCCs) smoked in the past week
| number of days | Newly Developed Warnings With Images | FDA Proposed Text-only Warnings | Control Group, no Intervention |
|---|---|---|---|
| Number of Days Smoked LCCs in Past Week | 3.46 ± 2.29 | 3.58 ± 2.31 | 3.46 ± 2.25 |
The mean number days that a participant reported smoking little cigars and cigarillos (LCCs) smoked in the past week
| number of days | Newly Developed Warnings With Images | FDA Proposed Text-only Warnings | Control Group, no Intervention |
|---|---|---|---|
| Number of Days Smoked LCCs in Past Week | 3.26 ± 2.40 | 3.50 ± 2.38 | 3.45 ± 2.28 |
The mean number days that a participant reported smoking little cigars and cigarillos (LCCs) smoked in the past week
| number of days | Newly Developed Warnings With Images | FDA Proposed Text-only Warnings | Control Group, no Intervention |
|---|---|---|---|
| Number of Days Smoked LCCs in Past Week | 3.15 ± 2.44 | 3.46 ± 2.47 | 3.41 ± 2.29 |
The mean number of little cigars and cigarillos (LCCs) smoked in the past week reported by participant
| number of LCCs | Newly Developed Warnings With Images | FDA Proposed Text-only Warnings | Control Group, no Intervention |
|---|---|---|---|
| Number of LCCs Smoked in the Past Week | 15.66 ± 23.13 | 16.05 ± 24.84 | 13.32 ± 17.32 |
The mean number of little cigars and cigarillos (LCCs) smoked in the past week reported by participant
| number of LCCs | Newly Developed Warnings With Images | FDA Proposed Text-only Warnings | Control Group, no Intervention |
|---|---|---|---|
| Number of LCCs Smoked in the Past Week | 14.67 ± 22.45 | 15.35 ± 22.37 | 13.47 ± 18.03 |
The mean number of little cigars and cigarillos (LCCs) smoked in the past week reported by participant
| number of LCCs | Newly Developed Warnings With Images | FDA Proposed Text-only Warnings | Control Group, no Intervention |
|---|---|---|---|
| Number of LCCs Smoked in the Past Week | 14.11 ± 20.30 | 15.89 ± 22.38 | 13.93 ± 18.94 |
The mean number of little cigars and cigarillos (LCCs) that participants reported butting out in the past week
| number of LCCs | Newly Developed Warnings With Images | FDA Proposed Text-only Warnings | Control Group, no Intervention |
|---|---|---|---|
| Number of LCCs Butted Out in the Past Week | 4.24 ± 7.86 | 3.64 ± 18.09 | 3.03 ± 6.51 |
The mean number of little cigars and cigarillos (LCCs) that participants reported butting out in the past week
| number of LCCs | Newly Developed Warnings With Images | FDA Proposed Text-only Warnings | Control Group, no Intervention |
|---|---|---|---|
| Number of LCCs Butted Out in the Past Week | 3.11 ± 5.22 | 3.48 ± 15.53 | 2.59 ± 5.71 |
The mean number of little cigars and cigarillos (LCCs) that participants reported butting out in the past week
| number of LCCs | Newly Developed Warnings With Images | FDA Proposed Text-only Warnings | Control Group, no Intervention |
|---|---|---|---|
| Number of LCCs Butted Out in the Past Week | 3.11 ± 5.41 | 3.46 ± 14.93 | 2.81 ± 5.67 |
The mean number of little cigars and cigarillos (LCCs) that participants reported forgoing in the past week
| number of LCCs | Newly Developed Warnings With Images | FDA Proposed Text-only Warnings | Control Group, no Intervention |
|---|---|---|---|
| Number of LCCs Forgone in the Past Week | 3.85 ± 5.24 | 3.64 ± 17.62 | 2.88 ± 4.83 |
The mean number of little cigars and cigarillos (LCCs) that participants reported forgoing in the past week
| number of LCCs | Newly Developed Warnings With Images | FDA Proposed Text-only Warnings | Control Group, no Intervention |
|---|---|---|---|
| Number of LCCs Forgone in the Past Week | 6.79 ± 30.85 | 3.47 ± 15.39 | 2.81 ± 4.31 |
The mean number of little cigars and cigarillos (LCCs) that participants reported forgoing in the past week
| number of LCCs | Newly Developed Warnings With Images | FDA Proposed Text-only Warnings | Control Group, no Intervention |
|---|---|---|---|
| Number of LCCs Forgone in the Past Week | 5.69 ± 14.67 | 4.30 ± 15.95 | 3.46 ± 7.30 |
The number and percent of participants who reported trying to quit smoking little cigars and cigarillos (LCCs) in the past week
| Participants | Newly Developed Warnings With Images | FDA Proposed Text-only Warnings | Control Group, no Intervention |
|---|---|---|---|
| LCC Quit Attempts in Past Week | 108 | 61 | 62 |
The number and percent of participants who reported trying to quit smoking little cigars and cigarillos (LCCs) in the past week
| Participants | Newly Developed Warnings With Images | FDA Proposed Text-only Warnings | Control Group, no Intervention |
|---|---|---|---|
| LCC Quit Attempts in Past Week | 102 | 71 | 66 |
The number and percent of participants who reported trying to quit smoking little cigars and cigarillos (LCCs) in the past week
| Participants | Newly Developed Warnings With Images | FDA Proposed Text-only Warnings | Control Group, no Intervention |
|---|---|---|---|
| LCC Quit Attempts in Past Week | 134 | 90 | 86 |
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.
| score on a scale | Newly Developed Warnings With Images | FDA Proposed Text-only Warnings | Control Group, no Intervention |
|---|---|---|---|
| LCC Quit Intentions | 2.76 ± 1.07 | 2.33 ± 1.05 | 2.46 ± 1.04 |
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.
| score on a scale | Newly Developed Warnings With Images | FDA Proposed Text-only Warnings | Control Group, no Intervention |
|---|---|---|---|
| LCC Quit Intentions | 2.82 ± 1.08 | 2.42 ± 1.09 | 2.51 ± 1.04 |
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.
| units on a scale | Newly Developed Warnings With Images | FDA Proposed Text-only Warnings |
|---|---|---|
| Self Reported Learning | 4.14 ± 1.01 | 3.60 ± 1.18 |
Collected over Low risk study, no adverse event data collected. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Newly Developed Warnings With Images | — | — | — |
| FDA Proposed Text-only Warnings | — | — | — |
| Control Group, no Intervention | — | — | — |
Everyone who enrolled in the study, consented to participate, completed the baseline questionnaire, and was randomized to each condition.
| Age, Continuous(years) | Newly Developed Warnings With Images | FDA Proposed Text-only Warnings | Control Group, no Intervention | Total |
|---|---|---|---|---|
| Mean | 43.03 ± 10.44 | 44.48 ± 11.73 | 44.07 ± 11.61 | 43.86 ± 11.29 |
| Sex/Gender, Customized(Participants) | Newly Developed Warnings With Images | FDA Proposed Text-only Warnings | Control Group, no Intervention | Total |
|---|---|---|---|---|
| Male | 175 | 208 | 195 | 578 |
| Female | 163 | 138 | 148 | 449 |
| Another Gender | 1 | 0 | 1 | 2 |
| Ethnicity (NIH/OMB)(Participants) | Newly Developed Warnings With Images | FDA Proposed Text-only Warnings | Control Group, no Intervention | Total |
|---|---|---|---|---|
| Hispanic or Latino | 68 | 50 | 52 | 170 |
| Not Hispanic or Latino | 270 | 294 | 291 | 855 |
| Unknown or Not Reported | 1 | 2 | 1 | 4 |
| Race/Ethnicity, Customized(Participants) | Newly Developed Warnings With Images | FDA Proposed Text-only Warnings | Control Group, no Intervention | Total |
|---|---|---|---|---|
| American Indian or Alaska Native | 5 | 4 | 1 | 10 |
| Asian | 21 | 13 | 19 | 53 |
| Native Hawaiian/Pacific Islander | 0 | 1 | 1 | 2 |
| Black/African American | 70 | 70 | 77 | 217 |
| White | 203 | 228 | 214 | 645 |
| More than one Race | 24 | 20 | 21 | 65 |
| Unknown not reported | 16 | 10 | 11 | 37 |
| Region of Enrollment(participants) | Newly Developed Warnings With Images | FDA Proposed Text-only Warnings | Control Group, no Intervention | Total |
|---|---|---|---|---|
| United States | 339 | 346 | 344 | 1029 |
Documents are hosted by the registry — open the source record to download them.
Plan to share: Yes — The investigators will make data collection instruments available for public use after data collection and analyses are complete. On request, the investigators will also make data sets available, stripped of individual identifiers, following publication of the study's main findings.
Supporting information: Study protocol, Sap, Icf
This study is completed, as verified in Jan 2025. You cannot join it, but the record below documents what was studied.
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UNC Lineberger Comprehensive Cancer Center