Little Cigars and Cigarillos (LCC) Use
Conditions
Keywords
cigarette warnings, youth, smoke cigars, nicotine addiction, cancer prevention, Black or African American youth
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.
Interventions
BEHAVIORALFDA warnings + Image
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.
BEHAVIORALFDA Warnings Text-Only
Participants will receive messages including images in 30% size.
BEHAVIORALSurgeon General Text-Only Warnings
Participants will receive messages including Surgeon General Text-only Warnings.
Sponsors
National Cancer Institute (NCI)
Food and Drug Administration (FDA)
UNC Lineberger Comprehensive Cancer Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
15 Years to 20 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Past 7 Days Cigarillo Use | Day 8 | The number of days in the past 7 days that a participant reported using cigarillos, range 0-7. Measured by survey, 1 item. |
| Little Cigar and Cigarillos (LCCs) Susceptibility | Day 8 | 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. |
| Cognitive Elaboration About Risk of Little Cigar and Cigarillo Use | Day 2 | 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. |
| Past 7 Days Little Cigar Use | Day 8 | The number of days in the past 7 days that a participant reported using little cigars, range 0-7. Measured by survey, 1 item. |
| Knowledge of Little Cigar and Cigarillo (LCC) Harms | Day 8 | Knowledge of LCC harms will be measured by 12 items the survey. Scores can range from 0 to 12 and indicate the number of questions out of 12 about LCC harms that participants answered correctly. |
| Beliefs About Little Cigar and Cigarillo (LCC) Harms | Day 8 | The average score on beliefs about LCC harms measured with 10 items by survey, are an average of the responses to the 10 questions. Belief scoring is on a scale of 1 to 5, where 1 indicates strong disagreement with statements about the health harms of LCCs and 5 indicates strong agreement with the statements about the health harms of LCCs. |
| Warning Negative Affect/Worry | Day 2 | 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. |
Countries
United States
Participant flow
Recruitment details
Participants were recruited and screened for study eligibility online between 7/18/2024- 11/25/2024 and invited to in the study once they were determined to be eligible.
Pre-assignment details
1,039 potential participants began the baseline survey. Of those, 9 did not consent to participate in the study, and 96 did not complete the baseline questionnaire and were not randomized, and 6 did not meet quality control criteria. 928 participants were enrolled and randomized in the study.
Participants by arm
| Arm | Count |
|---|---|
| FDA Warnings + Image Participants will receive FDA-proposed LCC warnings with images | 310 |
| FDA Warnings Text-Only Warnings Participants will receive FDA-proposed text-only LCC warnings. | 309 |
| Surgeon General Text-Only Warnings Participants will receive Surgeon General text-only LCC warnings. | 309 |
| Total | 928 |
Baseline characteristics
| Characteristic | FDA Warnings + Image | Total | Surgeon General Text-Only Warnings | FDA Warnings Text-Only Warnings |
|---|---|---|---|---|
| Age, Continuous | 18.5 years STANDARD_DEVIATION 1.4 | 18.5 years STANDARD_DEVIATION 1.5 | 18.4 years STANDARD_DEVIATION 1.5 | 18.4 years STANDARD_DEVIATION 1.5 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 73 Participants | 206 Participants | 65 Participants | 68 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 236 Participants | 717 Participants | 241 Participants | 240 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 1 Participants | 5 Participants | 3 Participants | 1 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 4 Participants | 17 Participants | 6 Participants | 7 Participants |
| Race (NIH/OMB) Asian | 15 Participants | 45 Participants | 17 Participants | 13 Participants |
| Race (NIH/OMB) Black or African American | 49 Participants | 157 Participants | 56 Participants | 52 Participants |
| Race (NIH/OMB) More than one race | 22 Participants | 53 Participants | 19 Participants | 12 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 1 Participants | 3 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 25 Participants | 84 Participants | 27 Participants | 32 Participants |
| Race (NIH/OMB) White | 194 Participants | 569 Participants | 183 Participants | 192 Participants |
| Region of Enrollment United States | 310 Participants | 928 Participants | 309 Participants | 309 Participants |
| Sex/Gender, Customized Female | 146 Participants | 481 Participants | 165 Participants | 170 Participants |
| Sex/Gender, Customized Male | 161 Participants | 442 Participants | 143 Participants | 138 Participants |
| Sex/Gender, Customized Unknown | 3 Participants | 5 Participants | 1 Participants | 1 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
Primary
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
Population: Participants who responded to the measures at the time point of interest, day 8
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| FDA Warnings + Image | Willingness to Use Little Cigars Cigarillos (LCCs) | 2.86 score on a scale | Standard Deviation 1.47 |
| FDA Warnings Text-Only Warnings | Willingness to Use Little Cigars Cigarillos (LCCs) | 3.08 score on a scale | Standard Deviation 1.39 |
| Surgeon General Text-Only Warnings | Willingness to Use Little Cigars Cigarillos (LCCs) | 2.99 score on a scale | Standard Deviation 1.4 |
Secondary
Beliefs About Little Cigar and Cigarillo (LCC) Harms
The average score on beliefs about LCC harms measured with 10 items by survey, are an average of the responses to the 10 questions. Belief scoring is on a scale of 1 to 5, where 1 indicates strong disagreement with statements about the health harms of LCCs and 5 indicates strong agreement with the statements about the health harms of LCCs.
Time frame: Day 8
Population: Participants who responded to the measures at the time point of interest, day 8
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| FDA Warnings + Image | Beliefs About Little Cigar and Cigarillo (LCC) Harms | 4.30 score on a scale | Standard Deviation 0.58 |
| FDA Warnings Text-Only Warnings | Beliefs About Little Cigar and Cigarillo (LCC) Harms | 4.31 score on a scale | Standard Deviation 0.54 |
| Surgeon General Text-Only Warnings | Beliefs About Little Cigar and Cigarillo (LCC) Harms | 4.24 score on a scale | Standard Deviation 0.59 |
Secondary
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 6
Population: Participants who responded to the scale at the time point of interest, day 6
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| FDA Warnings + Image | Cognitive Elaboration About Risk of Little Cigar and Cigarillo Use | 4.01 units on a scale | Standard Deviation 1.58 |
| FDA Warnings Text-Only Warnings | Cognitive Elaboration About Risk of Little Cigar and Cigarillo Use | 4.05 units on a scale | Standard Deviation 1.59 |
| Surgeon General Text-Only Warnings | Cognitive Elaboration About Risk of Little Cigar and Cigarillo Use | 3.78 units on a scale | Standard Deviation 1.67 |
Secondary
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 8
Population: Participants who responded to the scale at the time point of interest, day 8
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| FDA Warnings + Image | Cognitive Elaboration About Risk of Little Cigar and Cigarillo Use | 4.12 units on a scale | Standard Deviation 1.55 |
| FDA Warnings Text-Only Warnings | Cognitive Elaboration About Risk of Little Cigar and Cigarillo Use | 3.99 units on a scale | Standard Deviation 1.52 |
| Surgeon General Text-Only Warnings | Cognitive Elaboration About Risk of Little Cigar and Cigarillo Use | 4.00 units on a scale | Standard Deviation 1.6 |
Secondary
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 3
Population: Participants who responded to the scale at the time point of interest, day 3
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| FDA Warnings + Image | Cognitive Elaboration About Risk of Little Cigar and Cigarillo Use | 3.97 units on a scale | Standard Deviation 1.46 |
| FDA Warnings Text-Only Warnings | Cognitive Elaboration About Risk of Little Cigar and Cigarillo Use | 4.08 units on a scale | Standard Deviation 1.5 |
| Surgeon General Text-Only Warnings | Cognitive Elaboration About Risk of Little Cigar and Cigarillo Use | 3.74 units on a scale | Standard Deviation 1.64 |
Secondary
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 4
Population: Participants who responded to the scale at the time point of interest, day 4
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| FDA Warnings + Image | Cognitive Elaboration About Risk of Little Cigar and Cigarillo Use | 3.88 units on a scale | Standard Deviation 1.59 |
| FDA Warnings Text-Only Warnings | Cognitive Elaboration About Risk of Little Cigar and Cigarillo Use | 3.94 units on a scale | Standard Deviation 1.52 |
| Surgeon General Text-Only Warnings | Cognitive Elaboration About Risk of Little Cigar and Cigarillo Use | 3.74 units on a scale | Standard Deviation 1.65 |
Secondary
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 5
Population: Participants who responded to the scale at the time point of interest, day 5
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| FDA Warnings + Image | Cognitive Elaboration About Risk of Little Cigar and Cigarillo Use | 4.00 units on a scale | Standard Deviation 1.53 |
| FDA Warnings Text-Only Warnings | Cognitive Elaboration About Risk of Little Cigar and Cigarillo Use | 4.08 units on a scale | Standard Deviation 1.54 |
| Surgeon General Text-Only Warnings | Cognitive Elaboration About Risk of Little Cigar and Cigarillo Use | 3.88 units on a scale | Standard Deviation 1.64 |
Secondary
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 7
Population: Participants who responded to the scale at the time point of interest, day 7
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| FDA Warnings + Image | Cognitive Elaboration About Risk of Little Cigar and Cigarillo Use | 3.98 units on a scale | Standard Deviation 1.54 |
| FDA Warnings Text-Only Warnings | Cognitive Elaboration About Risk of Little Cigar and Cigarillo Use | 4.11 units on a scale | Standard Deviation 1.5 |
| Surgeon General Text-Only Warnings | Cognitive Elaboration About Risk of Little Cigar and Cigarillo Use | 3.83 units on a scale | Standard Deviation 1.7 |
Secondary
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
Population: Participants who responded to the scale at the time point of interest, day 2
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| FDA Warnings + Image | Cognitive Elaboration About Risk of Little Cigar and Cigarillo Use | 3.78 units on a scale | Standard Deviation 1.6 |
| FDA Warnings Text-Only Warnings | Cognitive Elaboration About Risk of Little Cigar and Cigarillo Use | 3.90 units on a scale | Standard Deviation 1.64 |
| Surgeon General Text-Only Warnings | Cognitive Elaboration About Risk of Little Cigar and Cigarillo Use | 3.91 units on a scale | Standard Deviation 1.6 |
Secondary
Knowledge of Little Cigar and Cigarillo (LCC) Harms
Knowledge of LCC harms will be measured by 12 items the survey. Scores can range from 0 to 12 and indicate the number of questions out of 12 about LCC harms that participants answered correctly.
Time frame: Day 8
Population: Participants who responded to the measures at the time point of interest, day 8
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| FDA Warnings + Image | Knowledge of Little Cigar and Cigarillo (LCC) Harms | 10.06 score on a scale | Standard Deviation 2.63 |
| FDA Warnings Text-Only Warnings | Knowledge of Little Cigar and Cigarillo (LCC) Harms | 10.12 score on a scale | Standard Deviation 2.46 |
| Surgeon General Text-Only Warnings | Knowledge of Little Cigar and Cigarillo (LCC) Harms | 9.71 score on a scale | Standard Deviation 2.82 |
Secondary
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
Population: Participants who responded to the measures at the time point of interest, day 8
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| FDA Warnings + Image | Little Cigar and Cigarillos (LCCs) Susceptibility | 2.33 score on a scale | Standard Deviation 0.97 |
| FDA Warnings Text-Only Warnings | Little Cigar and Cigarillos (LCCs) Susceptibility | 2.49 score on a scale | Standard Deviation 0.91 |
| Surgeon General Text-Only Warnings | Little Cigar and Cigarillos (LCCs) Susceptibility | 2.46 score on a scale | Standard Deviation 0.95 |
Secondary
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| FDA Warnings + Image | Past 7 Days Cigarillo Use | 1.93 number of days | Standard Deviation 2.57 |
| FDA Warnings Text-Only Warnings | Past 7 Days Cigarillo Use | 1.86 number of days | Standard Deviation 2.41 |
| Surgeon General Text-Only Warnings | Past 7 Days Cigarillo Use | 1.82 number of days | Standard Deviation 2.33 |
Secondary
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
Population: Participants who responded to the measures at the time point of interest, day 8
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| FDA Warnings + Image | Past 7 Days Little Cigar Use | 1.92 number of days | Standard Deviation 2.62 |
| FDA Warnings Text-Only Warnings | Past 7 Days Little Cigar Use | 1.86 number of days | Standard Deviation 2.6 |
| Surgeon General Text-Only Warnings | Past 7 Days Little Cigar Use | 1.88 number of days | Standard Deviation 2.59 |
Secondary
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.
Time frame: Day 7
Population: Participants who responded to the scale at the time point of interest, day 7
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| FDA Warnings + Image | Warning Negative Affect/Worry | 3.90 units on a scale | Standard Deviation 1.13 |
| FDA Warnings Text-Only Warnings | Warning Negative Affect/Worry | 3.79 units on a scale | Standard Deviation 1.15 |
| Surgeon General Text-Only Warnings | Warning Negative Affect/Worry | 3.79 units on a scale | Standard Deviation 1.16 |
Secondary
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.
Time frame: Day 2
Population: Participants who responded to the scale at the time point of interest, day 2
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| FDA Warnings + Image | Warning Negative Affect/Worry | 3.79 units on a scale | Standard Deviation 1.16 |
| FDA Warnings Text-Only Warnings | Warning Negative Affect/Worry | 3.85 units on a scale | Standard Deviation 1.23 |
| Surgeon General Text-Only Warnings | Warning Negative Affect/Worry | 3.61 units on a scale | Standard Deviation 1.26 |
Secondary
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.
Time frame: Day 3
Population: Participants who responded to the scale at the time point of interest, day 3
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| FDA Warnings + Image | Warning Negative Affect/Worry | 4.02 units on a scale | Standard Deviation 1.04 |
| FDA Warnings Text-Only Warnings | Warning Negative Affect/Worry | 3.42 units on a scale | Standard Deviation 1.24 |
| Surgeon General Text-Only Warnings | Warning Negative Affect/Worry | 3.48 units on a scale | Standard Deviation 1.26 |
Secondary
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.
Time frame: Day 4
Population: Participants who responded to the scale at the time point of interest, day 4
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| FDA Warnings + Image | Warning Negative Affect/Worry | 4.03 units on a scale | Standard Deviation 1.15 |
| FDA Warnings Text-Only Warnings | Warning Negative Affect/Worry | 3.55 units on a scale | Standard Deviation 1.25 |
| Surgeon General Text-Only Warnings | Warning Negative Affect/Worry | 3.65 units on a scale | Standard Deviation 1.2 |
Secondary
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.
Time frame: Day 5
Population: Participants who responded to the scale at the time point of interest, day 5
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| FDA Warnings + Image | Warning Negative Affect/Worry | 4.00 units on a scale | Standard Deviation 1.13 |
| FDA Warnings Text-Only Warnings | Warning Negative Affect/Worry | 3.52 units on a scale | Standard Deviation 1.38 |
| Surgeon General Text-Only Warnings | Warning Negative Affect/Worry | 3.36 units on a scale | Standard Deviation 1.29 |
Secondary
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.
Time frame: Day 6
Population: Participants who responded to the scale at the time point of interest, day 6
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| FDA Warnings + Image | Warning Negative Affect/Worry | 4.02 units on a scale | Standard Deviation 1.08 |
| FDA Warnings Text-Only Warnings | Warning Negative Affect/Worry | 3.72 units on a scale | Standard Deviation 1.23 |
| Surgeon General Text-Only Warnings | Warning Negative Affect/Worry | 3.71 units on a scale | Standard Deviation 1.23 |