Trial Outcomes & Findings for Little Cigar and Cigarillo Warnings to Reduce Tobacco-Related Cancers and Disease - Eye Tracking (NCT NCT06546618)

NCT ID: NCT06546618

Last Updated: 2026-07-02

Results Overview

Mean attention to warning areas of interest in seconds will be measured by dwell time to pre-defined areas of interest on the LCC packages. The mean amount of time in seconds that participants spend looking at the flavor area of interest for the 3 packages in each condition will be determined.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

90 participants

Primary outcome timeframe

During one time study appointment

Results posted on

2026-07-02

Participant Flow

Participants were recruited and screened for study eligibility online between July 2024 and March 2025, and invited to in the study once they were determined to be eligible.

90 participants arrived for their study appointment, began the study, and completed the study, which was a one-time appointment. All participants saw LCC pack stimuli images presented in random order, 4 package conditions were repeated with 3 warnings applied to each (12 stimuli total).

Participant milestones

Participant milestones
Measure
All Participants
All participants saw LCC pack stimuli images presented in random order, 4 package conditions were repeated with 3 warnings applied to each (12 stimuli total).
Overall Study
STARTED
90
Overall Study
Viewed All 3 LCC Packages With Pictorial Warning and No Flavor
90
Overall Study
Viewed All 3 LCC Packages With Pictorial Warnings and 'Sweet' Flavor
90
Overall Study
Viewed All 3 LCC Packages With Text-only Warnings and No Flavor
90
Overall Study
Viewed All 3 LCC Packages With Text-only Warnings and 'Sweet' Flavor
90
Overall Study
COMPLETED
90
Overall Study
NOT COMPLETED
0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Little Cigar and Cigarillo Warnings to Reduce Tobacco-Related Cancers and Disease - Eye Tracking

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
All Participants
n=90 Participants
All participants saw LCC pack stimuli images presented in random order, 4 package conditions were repeated with 3 warnings applied to each (12 stimuli total).
Age, Continuous
37.3 years
STANDARD_DEVIATION 12.8 • n=20 Participants
Sex/Gender, Customized
Man
53 Participants
n=20 Participants
Sex/Gender, Customized
Woman
35 Participants
n=20 Participants
Sex/Gender, Customized
Other
2 Participants
n=20 Participants
Race (NIH/OMB)
American Indian or Alaska Native
1 Participants
n=20 Participants
Race (NIH/OMB)
Asian
3 Participants
n=20 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants
n=20 Participants
Race (NIH/OMB)
Black or African American
48 Participants
n=20 Participants
Race (NIH/OMB)
White
25 Participants
n=20 Participants
Race (NIH/OMB)
More than one race
7 Participants
n=20 Participants
Race (NIH/OMB)
Unknown or Not Reported
6 Participants
n=20 Participants
Ethnicity (NIH/OMB)
Hispanic or Latino
9 Participants
n=20 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
80 Participants
n=20 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
1 Participants
n=20 Participants

PRIMARY outcome

Timeframe: During one time study appointment

Population: All participants, mean response to the 3 package stimuli in each condition were combined consistent with the study hypotheses examining the difference between warning type (text vs. pictorial) and flavor (no flavor vs. "SWEET" flavor).

Mean attention to warning areas of interest in seconds will be measured by dwell time to pre-defined areas of interest on the LCC packages. The mean amount of time in seconds that participants spend looking at the flavor area of interest for the 3 packages in each condition will be determined.

Outcome measures

Outcome measures
Measure
All Participants
n=90 Participants
All participants saw LCC pack stimuli images presented in random order, 4 package conditions were repeated with 3 warnings applied to each (12 stimuli total).
Attention to Warning Areas of Interest
Pictorial warning and no flavor
3.81 seconds
Standard Deviation 3.15
Attention to Warning Areas of Interest
Pictorial warning and 'sweet' flavor
3.34 seconds
Standard Deviation 3.89
Attention to Warning Areas of Interest
Text-only warning and no flavor
2.08 seconds
Standard Deviation 1.79
Attention to Warning Areas of Interest
Text-only warning and 'sweet' flavor
1.84 seconds
Standard Deviation 1.41

PRIMARY outcome

Timeframe: During one time study appointment

Population: All participants, mean response to the 3 package stimuli in each condition were combined consistent with the study hypotheses examining the difference between warning type (text vs. pictorial) and flavor (no flavor vs. "SWEET" flavor).

Mean attention to flavor areas of interest in seconds will be measured by dwell time to pre-defined areas of interest on the LCC packages. The mean amount of time in seconds that participants spend looking at the flavor area of interest for the 3 packages in each condition will be determined.

Outcome measures

Outcome measures
Measure
All Participants
n=90 Participants
All participants saw LCC pack stimuli images presented in random order, 4 package conditions were repeated with 3 warnings applied to each (12 stimuli total).
Attention to Flavor Areas of Interest
Pictorial warning and 'sweet' flavor
0.49 seconds
Standard Deviation 0.67
Attention to Flavor Areas of Interest
Text-only warning and no flavor
0.16 seconds
Standard Deviation 0.25
Attention to Flavor Areas of Interest
Pictorial warning and no flavor
0.17 seconds
Standard Deviation 0.26
Attention to Flavor Areas of Interest
Text-only warning and 'sweet' flavor
0.69 seconds
Standard Deviation 0.93

SECONDARY outcome

Timeframe: During one time study appointment

Population: All participants, mean response to the 3 package stimuli in each condition were combined consistent with the study hypotheses examining the difference between warning type (text vs. pictorial) and flavor (no flavor vs. "SWEET" flavor).

Mean positive affect response to warnings will be measured using an adaptation of the Discrete Emotions Questionnaire. The positive affect questionnaire will include 6 different emotions to measure participant's emotional responses to the cigarillo packages. Participants will rate to what extent they experienced each emotion while viewing the LCC package on a scale of 1 to 7, where 1=not at all and 7=an extreme amount. Higher affective responses indicate stronger positive emotional reactions to the LCC package. The mean positive affect will reflect the mean positive affect rating for the 3 packages in each condition.

Outcome measures

Outcome measures
Measure
All Participants
n=90 Participants
All participants saw LCC pack stimuli images presented in random order, 4 package conditions were repeated with 3 warnings applied to each (12 stimuli total).
Positive Affect
Pictorial warning and no flavor
1.39 units on a scale
Standard Deviation 0.85
Positive Affect
Pictorial warning and 'sweet' flavor
1.42 units on a scale
Standard Deviation 0.82
Positive Affect
Text-only warning and no flavor
1.90 units on a scale
Standard Deviation 1.08
Positive Affect
Text-only warning and 'sweet' flavor
2.07 units on a scale
Standard Deviation 1.21

SECONDARY outcome

Timeframe: During one time study appointment

Population: All participants, mean response to the 3 package stimuli in each condition were combined consistent with the study hypotheses examining the difference between warning type (text vs. pictorial) and flavor (no flavor vs. "SWEET" flavor).

Mean negative affect response to warnings will be measured using an adaptation of the Discrete Emotions Questionnaire. The negative affect questionnaire will include 6 different emotions to measure participant's emotional responses to the cigarillo packages. Participants will rate to what extent they experienced each emotion while viewing the LCC package on a scale of 1 to 7, where 1=not at all and 7=an extreme amount. Higher affective responses indicate stronger negative emotional reactions to the LCC package. The mean negative affect will reflect the mean negative affect rating for the 3 packages in each condition.

Outcome measures

Outcome measures
Measure
All Participants
n=90 Participants
All participants saw LCC pack stimuli images presented in random order, 4 package conditions were repeated with 3 warnings applied to each (12 stimuli total).
Negative Affect
Pictorial warning and no flavor
3.11 units on a scale
Standard Deviation 1.79
Negative Affect
Pictorial warning and 'sweet' flavor
3.09 units on a scale
Standard Deviation 1.82
Negative Affect
Text-only warning and no flavor
1.68 units on a scale
Standard Deviation 1.17
Negative Affect
Text-only warning and 'sweet' flavor
1.57 units on a scale
Standard Deviation 1.06

Adverse Events

All Participants

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Adam O Goldstein

UNC Lineberger Comprehensive Cancer Center

Phone: 919-270-6491

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place