Little Cigar and Cigarillo Warnings for Youth
- Conditions
- Little Cigars and Cigarillos (LCC) Use
- Interventions
- Behavioral: FDA Warnings Text-OnlyBehavioral: Surgeon General Text-Only WarningsBehavioral: FDA warnings + Image
- Registration Number
- NCT06413797
- Lead Sponsor
- UNC Lineberger Comprehensive Cancer Center
- Brief Summary
This study explores the effect of the little cigars and cigarillos (LCC) warnings on youth who currently use, have ever used, or are susceptible to using LCCs. This study will inform the Food and Drug Administration (FDA) implementation of LCC warnings, which can reduce LCC use and lessen tobacco health disparities among youth.
- Detailed Description
Cigar use exposes youth to the addictive effects of nicotine during a critical developmental period and increases the risk of multiple cancers and premature death. Recent data indicate that cigars are the second most commonly used tobacco product by youth and that past 30-day cigar use is 7.6%, which translates into 1.1 million high school students. Of the three major types of cigars-large cigars, little cigars, and cigarillos-little cigars and cigarillos (LCCs) are the most commonly used in the US, particularly among younger people. LCC use also contributes to tobacco health disparities, as Black or African American youth use cigars more frequently than other youth. In 2016, the Food and Drug Administration (FDA) deemed LCCs subject to FDA regulation, requiring six rotating text-only warning statements to be on LCC packaging. Previous research has examined the effectiveness of LCC warnings in reducing youth willingness to use LCCs.
Research from studies of cigarette warnings suggests that effective LCC warnings should employ images that illustrate negative health effects associated with use and a larger warning label prominently displayed on the pack. Among youth, health warnings on cigarette packs that contain both text statements and images are more effective and engaging than text-only warnings. However, evidence for cigarette warning labels cannot adequately inform implementation of improved LCC warnings for three reasons: 1) there is no evidence on the effectiveness of the FDA-mandated text-only LCC warnings on behavioral intentions or other outcomes among youth 2)courts have ruled that effective tobacco warnings on one type of tobacco product cannot be used to justify warnings on other types of tobacco, and 3) LCC users have different demographic and consumption profiles than cigarette users include more Black/African Americans and use LCCs on fewer days per month.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 928
- Members of the recruitment panel (we are partnering with a panel provider for the recruitment of all participants)
- Agree to provide their honest answers
- Susceptible to using LCCs, or have ever used little cigars and/or cigarillos, or currently use little cigar and/or cigarillos in the past 30 days
- Age 15 - 20 years old
- Currently living in US or US territory
- Able to complete 2 surveys that take approximately 15 minutes
- Able to complete a 2-minute survey each day for 6 days
- Able to verify they are not a bot using CAPTCHA
- Able to answer a simple, random math question
- Not able to verify they are not a bot using Completely Automated Public Turing test to tell Computers and Humans Apart (CAPTCHA).
- Not able to answer a simple, random math question.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description FDA Warnings Text-Only Warnings FDA Warnings Text-Only Participants will receive FDA-proposed text-only LCC warnings. Surgeon General Text-Only Warnings Surgeon General Text-Only Warnings Participants will receive Surgeon General text-only LCC warnings. FDA warnings + Image FDA warnings + Image Participants will receive FDA-proposed LCC warnings with images
- Primary Outcome Measures
Name Time Method Willingness to use little cigars cigarillos (LCCs) Day 8 The average willingness to use score will be measured by the average of the responses to the 2 survey questions scores. Question Scoring is on a scale of 1 to 5, where 1 indicates low willingness to use LCCs, and 5 indicates a willingness to use LCCs score.
- Secondary Outcome Measures
Name Time Method Cognitive elaboration about risk of little cigar and cigarillo use Days 2,3,4,5,6,7,8 Measured by survey, 1 item
Past 7 days little cigar use Day 8 Measured by survey, 1 item.
Past 7 days cigarillo use Day 8 Past 7 days cigarillos use will be measured with separate items for cigarillo and little cigar use by survey.
Little cigar and cigarillos (LCCs) susceptibility Day 8 little cigar and cigarillo (LCC) susceptibility will be measured with 3 items by survey.
Warning negative affect/worry Days 2,3,4,5,6,7,8 Warning negative affect/worry will be measured by the survey.
Knowledge of little cigar and cigarillo (LCC) harms Day 8 Knowledge of LCC harms will be measured by 12 items the survey.
Beliefs about little cigar and cigarillo (LCC) harms Day 8 Beliefs about little cigar and cigarillo (LCC) harms will be measured with 10 items by survey.
Trial Locations
- Locations (1)
Lineberger Comprehensive Cancer Center at University of North Carolina
🇺🇸Chapel Hill, North Carolina, United States