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| ID | Type | Description | Link |
|---|---|---|---|
| 4R00CA260718-02 | U.S. NIH Grant/Contract | View source | |
| NCI-2024-05891 | Other Identifier | NCI |
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| Name | Class |
|---|---|
| National Institutes of Health (NIH) | NIH |
| National Cancer Institute (NCI) | NIH |
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This trial refines and evaluates how cultural targeting influences the effectiveness of anti-tobacco messages among lesbian, gay, bisexual, and transgender (LGBT) young adults at risk for the use of more than one tobacco product (polytobacco use). Polytobacco use is associated with nicotine dependence and tobacco use into adulthood, and is disproportionately high among LGBT young adults. This trial seeks to determine how cultural targeting can be applied to communicate polytobacco use risk to at-risk LGBT young adults.
The goal of this study is to identify if culturally targeted (CT) or non-targeted (NT) anti-polytobacco messages are most effective for engaging LGBT consumers. Using the most effective NT messages from Aim 1, investigators will create a set of CT messages. Message framing will remain consistent between CT and NT messages; however, CT messages will include language and graphics representing LGBT values formative research and the existing peer-reviewed literature. Participants will be randomized to view CT or NT messages in a virtual lab where investigators will assess eye-tracking, self-reported perceived effectiveness, risk perceptions, and behavioral intentions. Participants will also complete a 1-week follow-up. The study aims to determine the effects of cultural targeting on attention to anti-polytobacco messages and perceived effectiveness among LGBT young adults susceptible to polytobacco use.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Culturally targeted messages | Experimental | Participants will view 8 nicotine and tobacco health messages with LGBT culturally targeted messages and imagery |
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| Non-targeted messages | Other | Participants will view 8 nicotine and tobacco health messages with universal messages and imagery |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Health communications | Behavioral | Participants will view eight culturally targeted or non-targeted health communications about the health risks of nicotine and tobacco use. |
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| Measure | Description | Time Frame |
|---|---|---|
| Visual Attention - Dwell Time | 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 (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. | During intervention on Day 1, on average 3 minutes. |
| Perceived Message Effectiveness - Message Perceptions | 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 | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Reactance | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Joanne G Patterson, PhD | The Ohio State University College of Public Health | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Ohio State University | Columbus | Ohio | 43210 | United States |
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| Label | URL |
|---|---|
| The Jamesline | View source |
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Participants who consented to the study but did not complete the activity in REDCap that triggered randomization to an arm, were excluded from the rest of the study.
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| ID | Title | Description |
|---|---|---|
| FG000 | Culturally Targeted Messages | Participants will view 8 nicotine and tobacco health messages with lesbian, gay, bisexual, and transgender (LGBT) culturally targeted messages and imagery |
| FG001 | Non-targeted Messages | Participants will view 8 nicotine and tobacco health messages with universal messages and imagery |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Culturally Targeted Messages | Participants will view 8 nicotine and tobacco health messages with LGBT culturally targeted messages and imagery Health communications: Participants will view eight culturally targeted or non-targeted health communications about the health risks of nicotine and tobacco use. |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Visual Attention - Dwell Time | 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. | Participants were included for analysis if they completed the eye-tracking experiment and were not missing dwell time data. | Posted | Mean | 95% Confidence Interval | milliseconds | During intervention on Day 1, on average 3 minutes |
|
One week
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Culturally Targeted Messages | Participants will view 8 nicotine and tobacco health messages with LGBT culturally targeted messages and imagery Health communications: Participants will view eight culturally targeted or non-targeted health communications about the health risks of nicotine and tobacco use. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Joanne G. Patterson | The Ohio State University College of Public Health | 614-247-1780 | patterson.1191@osu.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Nov 20, 2023 | May 29, 2025 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D058015 | Health Communication |
| ID | Term |
|---|---|
| D005159 | Health Care Facilities Workforce and Services |
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| Immediately post-exposure to intervention |
| Change in Behavioral Intentions | 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 |
| Behavioral Intentions: Quitting Smoking | Number of participants who answer "Yes" to the following: Do you plan to quit smoking cigarettes in the next 30 days? (Yes/No) | Difference between conditions in behavioral intentions to quit smoking at 1-week follow-up after intervention exposure |
| Behavioral Intentions to Quit Vaping | Number of participants who answer "Yes" to the following: "Do you plan to quit vaping nicotine in the next 30 days?" (Yes/No) | Difference between conditions in behavioral intentions to quit vaping at 1-week follow-up after intervention exposure |
| Ad Relevance | 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 |
| Liking | Single item; 5-point Likert scale where 1 = Strongly disagree and 5 = Strongly agree I like these messages. | Immediately post-exposure to intervention |
| Attitudes | 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 |
| Response Efficacy | 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 |
| Qualitative Recall of Health Messages | 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. | 1-week follow-up after intervention exposure |
| Non-targeted Messages |
Participants will view 8 nicotine and tobacco health messages with universal messages and imagery Health communications: Participants will view eight culturally targeted or non-targeted health communications about the health risks of nicotine and tobacco use. |
| BG002 | Total | Total of all reporting groups |
| Participants |
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| Sex/Gender, Customized | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Behavioral Intentions | Subscale 1: How likely is it that in the next 3 months, you will refrain from smoking cigarettes...completely and permanently? when you get lonely? when you are with your friends who use them? when someone hands you a cigarette? Subscale 2: How likely is it that in the next 3 months, you will refrain from vaping nicotine...completely and permanently? when you get lonely? when you are with your friends who use them? when someone hands you a vape? Subscale items were summed & averaged; final scores ranged from 1 (worse outcome) to 4 (better outcome). | Mean | Standard Deviation | units on a scale |
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| OG001 | Non-targeted Messages | Participants will view 8 nicotine and tobacco health messages with universal messages and imagery Health communications: Participants will view eight culturally targeted or non-targeted health communications about the health risks of nicotine and tobacco use. |
|
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| Primary | Visual Attention - Time to First Fixation | 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. | Participants were included for analysis if they completed eye-tracking and did not have missing data capturing time to first fixation. | Posted | Mean | 95% Confidence Interval | milliseconds | During intervention on Day 1, on average 3 minutes. |
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| Primary | Perceived Message Effectiveness - Message Perceptions | 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. | Analytic sample includes all participants for whom baseline and post-exposure data is available. | Posted | Mean | 95% Confidence Interval | score on a scale | Immediately post-exposure to intervention |
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| Primary | Perceived Message Effectiveness - Effects Perceptions | 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. | Analytic sample includes all participants for whom baseline and post-exposure data is available. | Posted | Mean | 95% Confidence Interval | score on a scale | Immediately post-exposure to intervention |
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| Primary | Change in Behavioral Intentions | 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) | Analytic sample includes all participants for whom baseline and post-exposure data is available. | Posted | Mean | 95% Confidence Interval | score on a scale | Change from Baseline in behavioral intentions immediately post-exposure to intervention |
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| Primary | Behavioral Intentions: Quitting Smoking | Number of participants who answer "Yes" to the following: Do you plan to quit smoking cigarettes in the next 30 days? (Yes/No) | Participants who reported current cigarette smoking at 1-week follow-up | Posted | Count of Participants | Participants | Difference between conditions in behavioral intentions to quit smoking at 1-week follow-up after intervention exposure |
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| Primary | Behavioral Intentions to Quit Vaping | Number of participants who answer "Yes" to the following: "Do you plan to quit vaping nicotine in the next 30 days?" (Yes/No) | Participants reporting nicotine vaping at follow-up | Posted | Count of Participants | Participants | Difference between conditions in behavioral intentions to quit vaping at 1-week follow-up after intervention exposure |
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| Secondary | Reactance | 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. | Analysis includes all participants for whom baseline and post-exposure data is available. | Posted | Mean | 95% Confidence Interval | score on a scale | Immediately post-exposure to intervention |
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| Secondary | Ad Relevance | 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. | Analysis includes all participants for whom baseline and post-exposure data is available. | Posted | Mean | 95% Confidence Interval | score on a scale | Immediately post-exposure to intervention |
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| Secondary | Liking | Single item; 5-point Likert scale where 1 = Strongly disagree and 5 = Strongly agree I like these messages. | Analysis includes all participants for whom baseline and post-exposure data is available. | Posted | Mean | 95% Confidence Interval | score on a scale | Immediately post-exposure to intervention |
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| Secondary | Attitudes | 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. | Analysis includes all participants for whom baseline and post-exposure data is available. | Posted | Mean | 95% Confidence Interval | score on a scale | Immediately post-exposure to intervention |
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| Secondary | Response Efficacy | 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. | Analysis includes all participants for whom baseline and post-exposure data is available. | Posted | Mean | 95% Confidence Interval | score on a scale | Immediately post-exposure to intervention |
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| Secondary | Qualitative Recall of Health Messages | 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. | Number of participants who reported recalling something about the health messages. | Posted | Count of Participants | Participants | 1-week follow-up after intervention exposure |
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| 0 |
| 129 |
| 0 |
| 129 |
| 0 |
| 129 |
| EG001 | Non-targeted Messages | Participants will view 8 nicotine and tobacco health messages with universal messages and imagery Health communications: Participants will view eight culturally targeted or non-targeted health communications about the health risks of nicotine and tobacco use. | 0 | 122 | 0 | 122 | 0 | 122 |
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| Textual AOI: Quit Resources |
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| Image AOI: Central Image |
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| Image AOI: Logo |
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| These messages will motivate NON-USERS to start vaping. |
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| These messages will motivate NON-USERS to start smoking cigarettes. |
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| These messages will motivate CIGARETTE SMOKERS to quit. |
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| These messages will motivate VAPERS to quit. |
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