Smoking, Cigar
Conditions
Keywords
Current cigarillo user, Cigar/cigarillo quit intentions, Pictorial warning format, Surgeon General text warning format, FDA text warning format
Brief summary
The goal of this study is to examine the impact of repeated exposure to cigarillo warnings on cigarillo users' intentions and behaviors for cigarillo smoking. Eligible participants will be randomized to one of three experimental conditions that will vary based on cigarillo warning format. For 4 weeks, participants will participate in an image-sorting task where they will be asked to sort a set of \ 18 cigarillo packages into flavor categories determined a priori by the research team (e.g., Mint, Fruit, Dessert). At the end of the study, participants will be notified of the purpose of the study and provided links to resources with information about the harms of cigarillo smoking and cessation. The study will be conducted in an online survey, working with Qualtrics research company, who will program the survey, recruit and screen participants, and administer the survey.
Interventions
OTHERPackage image sorting with pictorial warnings
Weekly for four weeks participants will complete an image-sorting task based on sorting cigarillos by flavor categories \[fruit (e.g., Grape), alcohol (e.g., Wine) desserts/candy (e.g., Sticky Sweets), mint (e.g., Menthol), color (e.g., Blue Crush), and other\]. Participants will sort 18 images of cigarillo packages from various brands with pictorial warnings on each pack.
OTHERPackage image sorting with Surgeon General text-only warnings
Weekly for four weeks participants will complete an image-sorting task based on sorting cigarillos by flavor categories \[fruit (e.g., Grape), alcohol (e.g., Wine) desserts/candy (e.g., Sticky Sweets), mint (e.g., Menthol), color (e.g., Blue Crush), and other\]. Participants will sort 18 images of cigarillo packages from various brands with Surgeon General text-only warnings on each pack.
OTHERPackage image sorting with FDA text-only warnings
Weekly for four weeks participants will complete an image-sorting task based on sorting cigarillos by flavor categories \[fruit (e.g., Grape), alcohol (e.g., Wine) desserts/candy (e.g., Sticky Sweets), mint (e.g., Menthol), color (e.g., Blue Crush), and other\]. Participants will sort 18 images of cigarillo packages from various brands with FDA text-only warnings on each pack.
Sponsors
Boston University
National Cancer Institute (NCI)
Wake Forest University Health Sciences
Brown University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
21 Years to 35 Years
Healthy volunteers
Yes
Inclusion criteria
* Current cigarillo user-used cigarillos at least one time per week in the past month * Recruited through Qualtrics Research Services
Exclusion criteria
* Not recruited through Qualtrics Research Services * Non-English speaking
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Intention to Quit Smoking Cigarillos in the Next 30 Days at Weeks 2-4 | Weeks 2-4 | Assessed by the score for 3 survey items: 1) how interested participants are in quitting cigarillo smoking in the next 30 days; 2) how likely they are to quit smoking cigarillos in the next 30 days; and 3) how much they plan to quit smoking cigarillos in the next 30 days. Each survey item has a 5-pt response scale (1=Not at all to 5= Extremely). All items are averaged to create a composite quit intentions score which can range from 1 to 5. Higher scores are associated with a greater intention to quit. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Interest Cutting Smoking | Weeks 2-4 | Assessed by a single survey item asking how interested participants are in cutting back or reducing the number of cigarillos they smoke in the next 30 days. The survey item has a 5-pt response scale (1=Not at all to 5= Extremely). Higher numbers are associated with greater interest in cutting back or reducing the number of cigarillos smoked in the next 30 days |
| Number of Participants in Week 2 Who Reported Specific Behaviors to Reduce Cigarillo Smoking for the Past Week | Week 2 | Assessed by 4 survey items with response options of yes/no: in the past week, have you: 1) butted out a cigarillo before you finished because you wanted to smoke less? 2) stopped yourself from smoking a cigarillo because you wanted to smoke less? 3) tried to quit cigarillos completely; 4) tried cutting back on your cigarillo smoking? |
| Number of Participants in Week 3 Who Reported Specific Behaviors to Reduce Cigarillo Smoking for the Past Week | Week 3 | Assessed by 4 survey items with response options of yes/no: in the past week, have you: 1) butted out a cigarillo before you finished because you wanted to smoke less? 2) stopped yourself from smoking a cigarillo because you wanted to smoke less? 3) tried to quit cigarillos completely; 4) tried cutting back on your cigarillo smoking? |
| Number of Participants in Week 4 Who Reported Specific Behaviors to Reduce Cigarillo Smoking for the Past Week | week 4 | Assessed by 4 survey items with response options of yes/no: in the past week, have you: 1) butted out a cigarillo before you finished because you wanted to smoke less? 2) stopped yourself from smoking a cigarillo because you wanted to smoke less? 3) tried to quit cigarillos completely; 4) tried cutting back on your cigarillo smoking? |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORJennifer Ross, PhD
School of Public Health - Health Law Policy & Management Dept
Participant flow
Recruitment details
Participants were recruited and screened for study eligibility online between January 6 and February 24, 2025, and invited to participate in the study once they were determined to be eligible.
Pre-assignment details
1020 potential participants began the baseline survey. Of those, 46 did not consent to participate in the study, and 193 did not complete the baseline questionnaire and were not randomized. 764 participants were enrolled and randomized in the study. 764 participants were included in the analysis. During the end of study de-briefing at the end of Week 4, 17 participants stated they did not want their data used, and thus were removed from the dataset.
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 29.1 years STANDARD_DEVIATION 4 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 66 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 184 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 1 Participants |
| Intention to Quit Smoking Cigarillos in the Next 30 Days | 2.35 scores on a scale STANDARD_DEVIATION 1.13 |
| Race (NIH/OMB) American Indian or Alaska Native | 7 Participants |
| Race (NIH/OMB) Asian | 8 Participants |
| Race (NIH/OMB) Black or African American | 271 Participants |
| Race (NIH/OMB) More than one race | 13 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 1 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 64 Participants |
| Race (NIH/OMB) White | 121 Participants |
| Region of Enrollment United States | 251 participants |
| Sex/Gender, Customized Man | 110 Participants |
| Sex/Gender, Customized Unknown | 10 Participants |
| Sex/Gender, Customized Woman | 137 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 0 | 0 / 0 | 0 / 0 |
| other Total, other adverse events | 0 / 0 | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 | 0 / 0 | 0 / 0 |
Outcome results
None listed