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| ID | Type | Description | Link |
|---|---|---|---|
| R01CA240732 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Newly developed warnings with images | Experimental | Participants receive newly developed warnings intervention |
|
| FDA proposed text-only warnings | Experimental | Participants receive FDA proposed text only warning intervention |
|
| Control group, no intervention | No Intervention | Participants do not receive an intervention |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Newly developed warnings with images at 30% size | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | day 21 (post test) |
| Measure | Description | Time Frame |
|---|---|---|
| Number of LCCs Smoked in Past Day | The mean number of little cigars and cigarillos (LCCs) smoked in the past day reported by participant. | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Adam O Goldstein | the University of North Carolina (UNC) Department of Family Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of North Carolina at Chapel Hill | Chapel Hill | North Carolina | 27599 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40815515 | Derived | Goldstein AO, Jarman KL, Ranney LM, Cornacchione Ross J, Kowitt SD, Enyioha C, Clark SA, Sheeran P, Thrasher JF, Jenson D, Vielot NA. Little Cigar and Cigarillo Graphic Health Warnings and Quitting Behaviors: A Randomized Clinical Trial. JAMA Netw Open. 2025 Aug 1;8(8):e2526799. doi: 10.1001/jamanetworkopen.2025.26799. |
| Label | URL |
|---|---|
| University of North Carolina Lineberger Comprehensive Cancer Center Clinical Trials | View source |
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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.
The supporting documents and data will become available when study results are submitted to ClinicalTrials.gov. Deidentified study data sets will be available, by request, following publication of the study's main findings.
The investigators will decide whether to share deidentified study data sets on a case by case basis, and will prioritize sharing the data sets with qualified tobacco regulatory science researchers.
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1,114 potential participants began the baseline survey. Of those, 44 did not consent to participate in the study, and 41 did not complete the baseline questionnaire and were not randomized. 1,029 participants were enrolled and randomized in the study.
Participants 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.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| FG002 | Control Group, no Intervention | Participants do not receive an intervention |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Everyone who enrolled in the study, consented to participate, completed the baseline questionnaire, and was randomized to each condition.
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | LCC Quit Intentions | Average quit intention score measured by survey. Quit intention measured with 3 questions, the final quit intention score is a mean of the response to the 3 questions, on a scale of 1 to 4, where 1 indicates low intention to quit, and 4 indicates a high intention to quit. | Participants who responded to the scale at the time point of interest, post test on day 21 | Posted | Mean | Standard Deviation | score on a scale | day 21 (post test) |
|
Low risk study, no adverse event data collected
Low risk study, no adverse event data collected
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Adam O Goldstein | UNC Lineberger Comprehensive Cancer Center | 919-270-6491 | AOG@med.unc.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP_ICF | Yes | Yes | Yes | Study Protocol, Statistical Analysis Plan, and Informed Consent Form | Apr 17, 2023 | Dec 4, 2024 | Prot_SAP_ICF_000.pdf |
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| ID | Term |
|---|---|
| D064424 | Tobacco Use |
| ID | Term |
|---|---|
| D001519 | Behavior |
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|
| FDA proposed text-only warnings at 30% size | Behavioral | 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. |
|
| 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. | 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. | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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. | 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. | 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. | day 21 (post test) |
| BG001 | 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. |
| BG002 | Control Group, no Intervention | Participants do not receive an intervention |
| BG003 | Total | Total of all reporting groups |
| years |
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| Sex/Gender, Customized | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
|
| OG001 | 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. |
| OG002 | Control Group, no Intervention | Participants do not receive an intervention |
|
|
| Secondary | Number of LCCs Smoked in Past Day | The mean number of little cigars and cigarillos (LCCs) smoked in the past day reported by participant. | Participants who responded to the measures at the time point of interest, day 1 | Posted | Mean | Standard Deviation | number of LCCs | day 1 |
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| Secondary | Number of LCCs Smoked in Past Day | The mean number of little cigars and cigarillos (LCCs) smoked in the past day reported by participant | Participants who responded to the measures at the time point of interest, day 2 | Posted | Mean | Standard Deviation | number of LCCs | day 2 |
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| Secondary | Number of LCCs Smoked in Past Day | The mean number of little cigars and cigarillos (LCCs) smoked in the past day was reported by participants. | Participants who responded to the measures at the time point of interest, day 3 | Posted | Mean | Standard Deviation | number of LCCs | day 3 |
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| Secondary | Number of LCCs Smoked in Past Day | The mean number of little cigars and cigarillos (LCCs) smoked in the past day reported by participant. | Participants who responded to the measures at the time point of interest, day 4 | Posted | Mean | Standard Deviation | number of LCCs | day 4 |
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| Secondary | Number of LCCs Smoked in Past Day | The mean number of little cigars and cigarillos (LCCs) smoked in the past day reported by participant | Participants who responded to the measures at the time point of interest, day 5 | Posted | Mean | Standard Deviation | number of LCCs | day 5 |
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| Secondary | Number of LCCs Smoked in Past Day | The mean number of little cigars and cigarillos (LCCs) smoked in the past day reported by participant | Participants who responded to the measures at the time point of interest, day 6 | Posted | Mean | Standard Deviation | number of LCCs | day 6 |
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| Secondary | Number of LCCs Smoked in Past Day | The mean number of little cigars and cigarillos (LCCs) smoked in the past day reported by participant | Participants who responded to the measures at the time point of interest, day 7 | Posted | Mean | Standard Deviation | number of LCCs | day 7 |
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| Secondary | Number of LCCs Smoked in Past Day | The mean number of little cigars and cigarillos (LCCs) smoked in the past day reported by participant | Participants who responded to the measures at the time point of interest, day 8 | Posted | Mean | Standard Deviation | number of LCCs | day 8 |
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| Secondary | Number of LCCs Smoked in Past Day | The mean number of little cigars and cigarillos (LCCs) smoked in the past day reported by participant | Participants who responded to the measures at the time point of interest, day 9 | Posted | Mean | Standard Deviation | number of LCCs | day 9 |
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| Secondary | Number of LCCs Smoked in Past Day | The mean number of little cigars and cigarillos (LCCs) smoked in the past day reported by participant | Participants who responded to the measures at the time point of interest, day 10 | Posted | Mean | Standard Deviation | number of LCCs | day 10 |
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| Secondary | Number of LCCs Smoked in Past Day | The mean number of little cigars and cigarillos (LCCs) smoked in the past day reported by participant | Participants who responded to the measures at the time point of interest, day 11 | Posted | Mean | Standard Deviation | number of LCCs | day 11 |
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| Secondary | Number of LCCs Smoked in Past Day | The mean number of little cigars and cigarillos (LCCs) smoked in the past day reported by participant | Participants who responded to the measures at the time point of interest, day 12 | Posted | Mean | Standard Deviation | number of LCCs | day 12 |
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| Secondary | Number of LCCs Smoked in Past Day | The mean number of little cigars and cigarillos (LCCs) smoked in the past day reported by participant | Participants who responded to the measures at the time point of interest, day 13 | Posted | Mean | Standard Deviation | number of LCCs | day 13 |
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| Secondary | Number of LCCs Smoked in Past Day | The mean number of little cigars and cigarillos (LCCs) smoked in the past day reported by participant | Participants who responded to the measures at the time point of interest, day 14 | Posted | Mean | Standard Deviation | number of LCCs | day 14 |
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| Secondary | Number of LCCs Smoked in Past Day | The mean number of little cigars and cigarillos (LCCs) smoked in the past day reported by participant | Participants who responded to the measures at the time point of interest, day 15 | Posted | Mean | Standard Deviation | number of LCCs | day 15 |
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| Secondary | Number of LCCs Smoked in Past Day | The mean number of little cigars and cigarillos (LCCs) smoked in the past day reported by participant | Participants who responded to the measures at the time point of interest, day 16 | Posted | Mean | Standard Deviation | number of LCCs | day 16 |
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| Secondary | Number of LCCs Smoked in Past Day | The mean number of little cigars and cigarillos (LCCs) smoked in the past day reported by participant | Participants who responded to the measures at the time point of interest, day 17 | Posted | Mean | Standard Deviation | number of LCCs | day 17 |
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| Secondary | Number of LCCs Smoked in Past Day | The mean number of little cigars and cigarillos (LCCs) smoked in the past day reported by participant | Participants who responded to the measures at the time point of interest, day 18 | Posted | Mean | Standard Deviation | number of LCCs | day 18 |
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| Secondary | Number of LCCs Smoked in Past Day | The mean number of little cigars and cigarillos (LCCs) smoked in the past day reported by participant | Participants who responded to the measures at the time point of interest, day 19 | Posted | Mean | Standard Deviation | number of LCCs | day 19 |
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| Secondary | Number of LCCs Smoked in Past Day | The mean number of little cigars and cigarillos (LCCs) smoked in the past day reported by participant | Participants who responded to the measures at the time point of interest, day 20 | Posted | Mean | Standard Deviation | number of LCCs | day 20 |
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| Secondary | Number of LCCs Smoked in Past Day | The mean number of little cigars and cigarillos (LCCs) smoked in the past day reported by participant | Participants who responded to the measures at the time point of interest, day 21 (post test) | Posted | Mean | Standard Deviation | number of LCCs | day 21 (post test) |
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| Secondary | Number of Days Smoked LCCs in Past Week | The mean number days that a participant reported smoking little cigars and cigarillos (LCCs) smoked in the past week | Participants who responded to the measures at the time point of interest, day 7 | Posted | Mean | Standard Deviation | number of days | day 7 |
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| Secondary | Number of Days Smoked LCCs in Past Week | The mean number days that a participant reported smoking little cigars and cigarillos (LCCs) smoked in the past week | Participants who responded to the measures at the time point of interest, day 14 | Posted | Mean | Standard Deviation | number of days | day 14 |
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| Secondary | Number of Days Smoked LCCs in Past Week | The mean number days that a participant reported smoking little cigars and cigarillos (LCCs) smoked in the past week | Participants who responded to the measures at the time point of interest, day 21 (post test) | Posted | Mean | Standard Deviation | number of days | day 21 (post test) |
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| Secondary | Number of LCCs Smoked in the Past Week | The mean number of little cigars and cigarillos (LCCs) smoked in the past week reported by participant | Participants who responded to the measures at the time point of interest, day 7 | Posted | Mean | Standard Deviation | number of LCCs | day 7 |
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| Secondary | Number of LCCs Smoked in the Past Week | The mean number of little cigars and cigarillos (LCCs) smoked in the past week reported by participant | Participants who responded to the measures at the time point of interest, day 14 | Posted | Mean | Standard Deviation | number of LCCs | day 14 |
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| Secondary | Number of LCCs Smoked in the Past Week | The mean number of little cigars and cigarillos (LCCs) smoked in the past week reported by participant | Participants who responded to the measures at the time point of interest, day 21 (post test) | Posted | Mean | Standard Deviation | number of LCCs | day 21 (post test) |
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| Secondary | Number of LCCs Butted Out in the Past Week | The mean number of little cigars and cigarillos (LCCs) that participants reported butting out in the past week | Participants who responded to the measures at the time point of interest, day 7 | Posted | Mean | Standard Deviation | number of LCCs | day 7 |
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| Secondary | Number of LCCs Butted Out in the Past Week | The mean number of little cigars and cigarillos (LCCs) that participants reported butting out in the past week | Participants who responded to the measures at the time point of interest, day 14 | Posted | Mean | Standard Deviation | number of LCCs | day 14 |
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| Secondary | Number of LCCs Butted Out in the Past Week | The mean number of little cigars and cigarillos (LCCs) that participants reported butting out in the past week | Participants who responded to the measures at the time point of interest, day 21 (post test) | Posted | Mean | Standard Deviation | number of LCCs | day 21 (post test) |
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| Secondary | Number of LCCs Forgone in the Past Week | The mean number of little cigars and cigarillos (LCCs) that participants reported forgoing in the past week | Participants who responded to the measures at the time point of interest, day 7 | Posted | Mean | Standard Deviation | number of LCCs | day 7 |
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| Secondary | Number of LCCs Forgone in the Past Week | The mean number of little cigars and cigarillos (LCCs) that participants reported forgoing in the past week | Participants who responded to the measures at the time point of interest, day 14 | Posted | Mean | Standard Deviation | number of LCCs | day 14 |
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| Secondary | Number of LCCs Forgone in the Past Week | The mean number of little cigars and cigarillos (LCCs) that participants reported forgoing in the past week | Participants who responded to the measures at the time point of interest, day 21 (post test) | Posted | Mean | Standard Deviation | number of LCCs | day 21 (post test) |
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| Secondary | LCC Quit Attempts in Past Week | The number and percent of participants who reported trying to quit smoking little cigars and cigarillos (LCCs) in the past week | Participants who responded to the measures at the time point of interest, day 7 | Posted | Count of Participants | Participants | day 7 |
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| Secondary | LCC Quit Attempts in Past Week | The number and percent of participants who reported trying to quit smoking little cigars and cigarillos (LCCs) in the past week | Participants who responded to the measures at the time point of interest, day 14 | Posted | Count of Participants | Participants | day 14 |
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| Secondary | LCC Quit Attempts in Past Week | The number and percent of participants who reported trying to quit smoking little cigars and cigarillos (LCCs) in the past week | Participants who responded to the measures at the time point of interest, day 21 (post test) | Posted | Count of Participants | Participants | day 21 (post test) |
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| Secondary | LCC Quit Intentions | Average quit intention score measured by survey. Quit intention measured with 3 questions, the final quit intention score is a mean of the response to the 3 questions, on a scale of 1 to 4, where 1 indicates low intention to quit, and 4 indicates a high intention to quit. | Participants who responded to the scale at the time point of interest, day 7 | Posted | Mean | Standard Deviation | score on a scale | day 7 |
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| Secondary | LCC Quit Intentions | Average quit intention score measured by survey. Quit intention measured with 3 questions, the final quit intention score is a mean of the response to the 3 questions, on a scale of 1 to 4, where 1 indicates low intention to quit, and 4 indicates a high intention to quit. | Participants who responded to the scale at the time point of interest, day 14 | Posted | Mean | Standard Deviation | score on a scale | day 14 |
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| Secondary | Self Reported Learning | Mean self-reported learning reported by participants. Self-reported learning measured with one item on a 1 to 5 scale, where 1 indicates no learning, and 5 indicates a great deal of learning from the warnings in the study. Self reported learning is only measured in conditions 1 and 2, the conditions that receive warnings. | 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) | Posted | Mean | Standard Deviation | units on a scale | day 21 (post test) |
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| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| EG001 | 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. | 0 | 0 | 0 | 0 | 0 | 0 |
| EG002 | Control Group, no Intervention | Participants do not receive an intervention | 0 | 0 | 0 | 0 | 0 | 0 |
Not provided
Not provided