Little Cigar and Cigarillo Warnings for Youth

UNC Lineberger Comprehensive Cancer Center928 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Enrollment

928

Conditions

Little Cigars and Cigarillos (LCC) Use

Interventions

FDA warnings + ImageBEHAVIORAL

For six days (days 2-7) participants will be contacted and asked to complete a daily survey. As part of the survey, participants will view FDA-proposed LCC warnings with images at 30% size on a cigarillo package. Participants will be contacted each day to be invited to complete the survey for that day of the study protocol.

FDA Warnings Text-OnlyBEHAVIORAL

Participants will receive messages including images in 30% size.

Surgeon General Text-Only WarningsBEHAVIORAL

Participants will receive messages including Surgeon General Text-only Warnings.

Eligibility

Sex: ALLMin age: 15 YearsMax age: 20 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: 1. Members of the recruitment panel (we are partnering with a panel provider for the recruitment of all participants) 2. Agree to provide their honest answers 3. 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 4. Age 15 - 20 years old 5. Currently living in US or US territory 6. Able to complete 2 surveys that take approximately 15 minutes 7. Able to complete a 2-minute survey each day for 6 days 8. Able to verify they are not a bot using CAPTCHA 9. Able to answer a simple, random math question Exclusion Criteria: * 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.

Locations (1)

Lineberger Comprehensive Cancer Center at University of North Carolina

Chapel Hill, North Carolina, United States

Outcomes

Primary Outcomes

Willingness to Use Little Cigars Cigarillos (LCCs)

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.

Time frame: Day 8

Secondary Outcomes

Past 7 Days Little Cigar Use

The number of days in the past 7 days that a participant reported using little cigars, range 0-7. Measured by survey, 1 item.

Time frame: Day 8

Past 7 Days Cigarillo Use

The number of days in the past 7 days that a participant reported using cigarillos, range 0-7. Measured by survey, 1 item.

Time frame: Day 8

Little Cigar and Cigarillos (LCCs) Susceptibility

The average susceptibility to little cigar and cigarillo (LCC) use measured with the average of 3 survey item scores. Question scoring is on a scale of 1 to 4, where 1 indicates high susceptibility and 4 indicates low susceptibility to LCCs.

Time frame: Day 8

Cognitive Elaboration About Risk of Little Cigar and Cigarillo Use

The cognitive elaboration score is measured by survey with 1 item. Question scoring is on a scale of 1 to 6, where 1 indicates that the participant has low cognitive elaboration about the health risks of LCCs and 6 indicates that a participant has high cognitive elaboration about smoking LCCs.

Time frame: Day 2

Warning Negative Affect/Worry

Warning negative affect/worry is measured by survey with 1 item. Question scoring is on a scale of 1 to 5, where 1 indicates low worry due to the warning and 5 indicates high worry due to the warning.

Data from ClinicalTrials.gov

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