Little Cigar and Cigarillo Warnings Among US Adults Who Use LCCs

Not Applicable

Completed

Conditions: Tobacco Use

Interventions: Behavioral: Newly developed warnings with images at 30% size
Behavioral: FDA proposed text-only warnings at 30% size

Registration Number: NCT05849051

Lead Sponsor: UNC Lineberger Comprehensive Cancer Center

Brief Summary: The goal of this research is to assess whether little Cigars and cigarillos (LCC) warnings developed by the study team are more effective than the current warnings proposed by FDA for LCC products. A 3-week web-based randomized controlled trial will be conducted in the United States. Participants are adult persons who currently use LCCs.

Detailed Description: In this study, LCC warnings on packs will be electronically presented to participants over time to determine if newly developed LCC warnings increase quit intentions compared to FDA-proposed text-only warnings and a control condition (in which participants do not see LCC packs or warnings.) A daily diary methodology will be employed to present LCC warnings on packs to participants over time. Qualtrics will contact, screen, consent, and administer the survey. To enroll participants, Qualtrics will screen participants using the inclusion criteria and measures and invite eligible participants to enroll in the study.

At the beginning of the baseline survey (day 0), participants will first consent to participate in the study and then complete a questionnaire about their tobacco use and behaviors (e.g., intentions and quit attempts) and other measures of interest. At the end of the baseline questionnaire, survey software will randomly assign participants to one of the 3 study conditions. The three study conditions are 1) Newly developed warnings with images (the six most effective warnings developed by the study team), 2) FDA-proposed text-only warnings, or 3) control condition in which participants will not receive an intervention (no warnings). Participants will be contacted via email each day (at approximately 6 am) to invite them to complete the survey for that day of the study protocol.

For subsequent days (days 1-6, 8-13, 15-20) participants will be contacted and asked to complete a daily survey which will assess their previous day use of LCCs, as well as cigarettes and e-cigarettes. During these daily surveys, participants assigned to condition 1 or 2 (i.e., the warning conditions) will view an image of a little cigar and cigarillo package with a warning according to the participant's condition. Participants within each warning condition will view a total of 6 different warnings over the course of 6 days each week, this will be repeated 3 times during the study, resulting in a total of 18 exposures. Participants will be required to view the warning for at least 5 seconds before answering questions.

On days 7 and 14 participants will be asked to complete a slightly longer survey with questions about their LCC behaviors including the number of LCCs used in the past week, the number of LCCs butted out because they wanted to smoke less, the number of LCCs forgone, other tobacco use, blunt use, and quit intentions and attempts.

For the post-test on day 21, participants will be asked to complete a longer questionnaire about their current tobacco use and behaviors including current LCC smoking behavior, LCC nicotine dependence, other tobacco product (OTP) use, LCC and OTP quit intentions, and LCC and O

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 1029

Inclusion Criteria

Members of the recruitment panel (the investigators are partnering with a panel provider for recruitment of all participants)
Agree to provide their honest answers
Current little cigar and/or cigarillo every day or some day users
Over 21 years old
Currently living in US
Feel comfortable taking a survey in English without help
Feel comfortable taking an online survey without help
Have an email address that they check regularly
Have access to the internet at work or home
Able to read and respond to surveys delivered to their email
Able to complete 2 surveys that take approximately 20 minutes
Able to complete a 5 minute survey each day for 20 days
Able to verify they are not a bot using CAPTCHA
Able to answer a simple, random math question

Exclusion Criteria

None

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Newly developed warnings with images	Newly developed warnings with images at 30% size	Participants receive newly developed warnings intervention
FDA proposed text-only warnings	FDA proposed text-only warnings at 30% size	Participants receive FDA proposed text only warning intervention

Primary Outcome Measures

Name	Time	Method
LCC Quit Intentions	day 21 (post test)	Average quit intention score measured by survey. Quit intention measured with 3 questions, the final quit intention score is a mean of the response to the 3 questions, on a scale of 1 to 4, where 1 indicates low intention to quit, and 4 indicates a high intention to quit.

Secondary Outcome Measures

Name	Time	Method
Number of LCCs Forgone in the Past Week	day 21 (post test)	The mean number of little cigars and cigarillos (LCCs) that participants reported forgoing in the past week
Number of LCCs Smoked in Past Day	day 21 (post test)	The mean number of little cigars and cigarillos (LCCs) smoked in the past day reported by participant
Number of Days Smoked LCCs in Past Week	day 21 (post test)	The mean number days that a participant reported smoking little cigars and cigarillos (LCCs) smoked in the past week
Number of LCCs Smoked in the Past Week	day 21 (post test)	The mean number of little cigars and cigarillos (LCCs) smoked in the past week reported by participant
Number of LCCs Butted Out in the Past Week	day 21 (post test)	The mean number of little cigars and cigarillos (LCCs) that participants reported butting out in the past week
LCC Quit Attempts in Past Week	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
LCC Quit Intentions	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.
Self Reported Learning	day 21 (post test)	Mean self-reported learning reported by participants. Self-reported learning measured with one item on a 1 to 5 scale, where 1 indicates no learning, and 5 indicates a great deal of learning from the warnings in the study. Self reported learning is only measured in conditions 1 and 2, the conditions that receive warnings.