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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05972941
Other study ID # OSU-23020
Secondary ID 4R00CA260718-02
Status Completed
Phase N/A
First received
Last updated
Start date June 19, 2023
Est. completion date February 6, 2024

Study information

Verified date April 2024
Source Ohio State University Comprehensive Cancer Center
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Description:

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.


Recruitment information / eligibility

Status Completed
Enrollment 252
Est. completion date February 6, 2024
Est. primary completion date January 29, 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 35 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Health communications
Participants will view eight culturally targeted or non-targeted health communications about the health risks of nicotine and tobacco use.

Locations

Country Name City State
United States The Ohio State University Columbus Ohio

Sponsors (3)

Lead Sponsor Collaborator
Ohio State University Comprehensive Cancer Center National Cancer Institute (NCI), National Institutes of Health (NIH)

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Visual attention - dwell time Visual attention measured by dwell time (milliseconds) on areas of interest (text, graphic) measured via eye-tracking During intervention
Primary Visual attention - time to first fixation Time (milliseconds) to first fixation on areas of interest (text, graphic) measured via eye-tracking During intervention
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.
Immediately post-exposure to intervention
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. 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.
Immediately post-exposure to intervention
Primary Change in harm perceptions 3-items; 4-point scale 1=No harm to 4 = A lot of harm How harmful are nicotine vapes to your health? Compared to combustible cigarettes, how harmful are nicotine vapes to your health? How harmful are combustible cigarettes to your health? Change from Baseline in harm perceptions immediately post-exposure to intervention
Primary Change in harm perceptions 3-items; 4-point scale 1=No harm to 4 = A lot of harm How harmful are nicotine vapes to your health? Compared to combustible cigarettes, how harmful are nicotine vapes to your health? How harmful are combustible cigarettes to your health? Change from Baseline in harm perceptions at 1-week follow-up after intervention exposure
Primary Change in behavioral intentions 8 items total. 4-point scale 1 = Definitely not to 4 = Definitely will.
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?
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 vape?
Change from Baseline in behavioral intentions immediately post-exposure to intervention
Primary Change in behavioral intentions Do you plan to quit smoking cigarettes in the next 30 days (Yes/No) Do you plan to quit vaping in the next 30 days (Yes/No) Change from Baseline in behavioral intentions at 1-week follow-up after intervention exposure
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.
Immediately post-exposure to intervention
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. Immediately post-exposure to intervention
Secondary Liking Single item; 5-point Likert scale where 1 = Strongly disagree and 5 = Strongly agree
I like these messages.
Immediately post-exposure to intervention
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?
Immediately post-exposure to intervention
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.
Immediately post-exposure to intervention
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?" 1-week follow-up after intervention exposure
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