- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05972941
Nicotine and Tobacco Message Framing Among LGBT Young Adults
The Effect of Nicotine and Tobacco Message Framing on Use Among Diverse Groups of Young Adults
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Ohio
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Columbus, Ohio, United States, 43210
- The Ohio State University
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Speaks English fluently
- Self-identifies as lesbian, gay, bisexual, transgender, queer, or another non- heterosexual orientation or non-binary gender identity
- Ever used e-cigarettes AND combustible cigarettes
- Currently uses e-cigarettes, combustible cigarettes, or both e-cigarettes and combustible cigarettes
- Resides in the United States
- Access to a laptop or desktop computer with a camera for virtual eye-tracking
Exclusion Criteria:
- Glaucoma
- Cataracts
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Culturally targeted messages
Participants will view 8 nicotine and tobacco health messages with LGBT culturally targeted messages and imagery
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Participants will view eight culturally targeted or non-targeted health communications about the health risks of nicotine and tobacco use.
|
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Other: Non-targeted messages
Participants will view 8 nicotine and tobacco health messages with universal messages and imagery
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Participants will view eight culturally targeted or non-targeted health communications about the health risks of nicotine and tobacco use.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Visual Attention - Dwell Time
Time Frame: During intervention on Day 1, on average 3 minutes
|
Visual attention measured by dwell time (milliseconds) on areas of interest (AOI; e.g., text, graphic) within a stimuli was assessed via eye-tracking for each message (n=8).
Dwell times on AOIs were summed for all stimuli viewed by each participant and averaged.
Scores represent total average dwell time on AOIs across stimuli.
|
During intervention on Day 1, on average 3 minutes
|
|
Visual Attention - Time to First Fixation
Time Frame: During intervention on Day 1, on average 3 minutes.
|
Time (milliseconds) to first fixation on areas of interest (text, graphic) within a stimuli was assessed via eye-tracking for each message (n=8).
Time to first fixation on a specific AOI was summed for all stimuli viewed by each participant and averaged.
Scores represent total average time to first fixation on AOIs across stimuli.
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During intervention on Day 1, on average 3 minutes.
|
|
Perceived Message Effectiveness - Message Perceptions
Time Frame: Immediately post-exposure to intervention
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6-items on a 5-point scale where 1 = Not at all and 5 = Very much. Please rate each statement from 1 (not at all) to 5 (very much). These message are worth remembering. These messages grabbed my attention. These messages are powerful. These messages are convincing. These messages are meaningful. These messages are informative. Individual items are summed and averaged for a total score ranging from 1 to 5. Higher scores indicate a better outcome. |
Immediately post-exposure to intervention
|
|
Perceived Message Effectiveness - Effects Perceptions
Time Frame: Immediately post-exposure to intervention
|
6-items. 5-point scale where 1 = Strongly disagree to 5 = Strongly agree These messages discourage me from smoking cigarettes. These messages make me concerned about the negative effects of smoking cigarettes These messages make smoking cigarettes seem unpleasant to me. 3-items above are summed and averaged. Higher scores indicate better outcome. These messages discourage me from vaping nicotine. These messages make me concerned about the negative effects of vaping nicotine. These messages make vaping nicotine seem unpleasant to me. 3-items above are summed and averaged for a total score ranging from 1 to 5. Higher scores indicate a better outcome. |
Immediately post-exposure to intervention
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Change in Behavioral Intentions
Time Frame: Change from Baseline in behavioral intentions immediately post-exposure to intervention
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8 items total. 4-point scale 1 = Definitely not to 4 = Definitely will. The following items were asked at baseline and post-exposure. How likely is it that in the next 3 months, you will refrain from vaping nicotine....
How likely is it that in the next 3 months, you will refrain from smoking cigarettes...
For each subscale, pre-test and post-test items were summed and averaged. Change scores were calculated for each subscale by subtracting pre-test scores from post-test scores. Change scores could range from 0 to 3. Higher change scores indicate a better outcome (i.e. greater change in intentions to refrain from smoking or vaping) |
Change from Baseline in behavioral intentions immediately post-exposure to intervention
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Behavioral Intentions: Quitting Smoking
Time Frame: Difference between conditions in behavioral intentions to quit smoking at 1-week follow-up after intervention exposure
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Number of participants who answer "Yes" to the following: Do you plan to quit smoking cigarettes in the next 30 days?
(Yes/No)
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Difference between conditions in behavioral intentions to quit smoking at 1-week follow-up after intervention exposure
|
|
Behavioral Intentions to Quit Vaping
Time Frame: Difference between conditions in behavioral intentions to quit vaping at 1-week follow-up after intervention exposure
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Number of participants who answer "Yes" to the following: "Do you plan to quit vaping nicotine in the next 30 days?" (Yes/No)
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Difference between conditions in behavioral intentions to quit vaping at 1-week follow-up after intervention exposure
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Liking
Time Frame: Immediately post-exposure to intervention
|
Single item; 5-point Likert scale where 1 = Strongly disagree and 5 = Strongly agree I like these messages. |
Immediately post-exposure to intervention
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Reactance
Time Frame: Immediately post-exposure to intervention
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3-items; 5-point Likert scale where 1 = Strongly disagree and 5 = Strongly agree These messages are trying to manipulate me. These messages annoy me. The health effects of these messages are overblown. Items are summed and averaged for a total score ranging from 1 to 5. Higher scores indicate a worse outcome. |
Immediately post-exposure to intervention
|
|
Ad Relevance
Time Frame: Immediately post-exposure to intervention
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5 items; 7-point Likert scale where 1 = Strongly Disagree and 7 = Strongly agree These ads were created just for me. These ads were created for people like me. These ads were relevant to me. These ads were of value to me. These ads were important to me. Items were summed and averaged for a total score ranging from 1 to 7. Higher scores indicate a better outcome. |
Immediately post-exposure to intervention
|
|
Attitudes
Time Frame: Immediately post-exposure to intervention
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Two items; 7-point Likert scale where 1 = These message made me feel much worse and 7 = These message made me feel much better. Did these messages change how you feel about smoking combustible cigarettes? Did these messages change how you feel about vaping nicotine? Higher scores mean a worse outcome. |
Immediately post-exposure to intervention
|
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Response Efficacy
Time Frame: Immediately post-exposure to intervention
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6-items; 5 point Likert scale where 1 = Strongly disagree and 5 = Strongly agree These messages will motivate CIGARETTE SMOKERS to switch to vaping. These messages will motivate people to quit ALL smoking and vaping. These messages will motivate NON-USERS to start vaping. These messages will motivate NON-USERS to start smoking cigarettes. These messages will motivate CIGARETTE SMOKERS to quit. These messages will motivate VAPERS to quit. Higher scores mean a better outcome. |
Immediately post-exposure to intervention
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Qualitative Recall of Health Messages
Time Frame: 1-week follow-up after intervention exposure
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Participants will be asked the following question: "The images that you viewed included health messages.
What do you remember about the health messages?"
Outcome indicates then number of participants who qualitatively reported recalling something about the health message.
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1-week follow-up after intervention exposure
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Collaborators and Investigators
Investigators
- Principal Investigator: Joanne G Patterson, PhD, The Ohio State University College of Public Health
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- OSU-23020
- 4R00CA260718-02 (U.S. NIH Grant/Contract)
- NCI-2024-05891 (Other Identifier: NCI)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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