- ICH GCP
- USA klinikai vizsgálatok nyilvántartása
- Klinikai vizsgálat NCT07782879
DoubleTake: Effect of Message Exposure Via a Discrete Choice Experiment With Eye-Tracking on Quit Attempts Among Adults Who Smoke Menthol Cigarettes
The DoubleTake Study: A Randomized, Waitlist-Controlled Trial of Message Exposure Delivered Via a Discrete Choice Experiment With Eye-Tracking on Quit Attempts Among Adults Who Smoke Menthol Cigarettes
<p>The goal of this clinical trial is to learn how exposure to anti-smoking social media messages affects quitting-related behaviors. Eligible participants will be adults aged 21 or older who have used menthol cigarettes on at least 4 days during the past 30 days.</p> <br> <p>The main question this study aims to answer is: Does exposure to anti-smoking messages (in the context of a discrete choice experiment [DCE] with eye-tracking study) increase quitting-related behaviors over the following 2 weeks?</p> <br> <p>Participants will be randomly assigned to view the messages either immediately or after a 2-week waiting period, allowing researchers to compare quitting-related behaviors between the two groups. The primary outcome is whether participants report making a quit attempt in the 2 weeks following randomization.</p> <br> <p>Participants will:</p> <ul> <li>Complete eligibility screening and baseline questions about demographics and tobacco use.</li> <li>Be randomly assigned to view the messages immediately or after a 2-week waiting period.</li> <li>Attend a 1-hour in-person study visit at Georgia State University or the University of California, Santa Barbara.</li> <li>View 64 anti-smoking social media messages presented in 16 choice sets while their eye movements and pupil dilation are measured using a screen-based eye-tracking device.</li> <li>Select which messages most attract their attention, which they would be most likely to share, and which would most motivate them to quit smoking.</li> <li>Complete questions about quitting-related behaviors either during the study visit (waitlist control condition) or through an online questionnaire 2 weeks later (immediate condition).</li> </ul>
A tanulmány áttekintése
Állapot
Beavatkozás / kezelés
Részletes leírás
<p>Discrete choice experiments (DCEs) are increasingly used in tobacco research to understand which message features people perceive as most effective. However, DCE studies are typically designed to assess message preferences and are not designed to test whether exposure to these messages has any downstream effect on actual behavior. Because DCEs expose participants to a large number of messages in a single session, a much higher dose of message exposure than in typical single- or few-message studies, it is possible that this cumulative exposure itself influences quitting-related outcomes such as making a quit attempt. This study (DoubleTake) is a randomized controlled trial designed to address this gap by testing whether exposure to multiple messages in the context of a DCE with concurrent eye-tracking affects quitting-related behaviors among adults who smoke menthol cigarettes, a population disproportionately affected by tobacco-related health disparities.</p> <br> <p>The study is a two-arm, randomized, waitlist-controlled trial with a planned total enrollment of approximately 200 participants (approximately 100 per arm). After completing eligibility screening and baseline questions on demographics and tobacco use, eligible participants will be randomly assigned to one of two conditions:</p>
<ul> <li><b>Immediate condition:</b> Participants complete the in-person DCE/eye-tracking study visit right away and then complete an online questionnaire assessing quitting-related behaviors 2 weeks later.</li> <li><b>Waitlist control condition:</b> Participants wait 2 weeks and then attend an in-person visit, at the start of which they answer questions about quitting-related behaviors covering the preceding 2-week waiting period, and then complete the DCE/eye-tracking study.</li> </ul>
<p>This design allows researchers to isolate the effect of message exposure on quitting-related behaviors by comparing outcomes reported by the immediate condition (after exposure) to those reported by the waitlist condition (before exposure, over an equivalent 2-week window).</p> <br> <p>All participants will attend a 1-hour in-person study visit at one of two sites (Georgia State University or the University of California, Santa Barbara). During this visit, participants will view 64 anti-smoking social media messages, presented across 16 choice sets, while an eye-tracking device records their eye movements and pupil dilation. Within each choice set, participants will indicate which message most attracts their attention, which they would be most likely to share, and which would most motivate them to quit smoking.</p> <br> <p>The primary outcome is a self-reported quit attempt within 2 weeks following randomization. Secondary outcome is intentions to quit smoking.</p>
Tanulmány típusa
Beiratkozás (Becsült)
Fázis
- Nem alkalmazható
Kapcsolatok és helyek
Tanulmányi kapcsolat
- Név: Lyudmila Popova, Ph.D
- Telefonszám: 404-413-9338
- E-mail: lpopova1@gsu.edu
Tanulmányi helyek
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California
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Santa Barbara, California, Egyesült Államok, 93106
- Még nincs toborzás
- University of California, Santa Barbara
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Kapcsolatba lépni:
- Jiyaing Liu, Ph.D.
- Telefonszám: (805) 893-8000
- E-mail: jiaying-liu@ucsb.edu
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Georgia
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Atlanta, Georgia, Egyesült Államok, 30303
- Toborzás
- Georgia State University
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Kapcsolatba lépni:
- Lyudmila Popova, Ph.D.
- Telefonszám: 404-413-9338
- E-mail: lpopova1@gsu.edu
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Részvételi kritériumok
Jogosultsági kritériumok
Tanulmányozható életkorok
Egészséges önkénteseket fogad
Tanulmányozható nemek
Leírás
Inclusion Criteria:
- Age 21+ years
- Smoked menthol cigarettes at least once a week in the past 30 days
- Can speak, read, and write in English
- Willing to participate in an in-person study
Exclusion Criteria:
- Eye conditions affecting fixation, ocular motility, or central acuity (e.g., strabismus, nystagmus, ptosis, aniridia, maculopathy, advanced cataracts, or other conditions affecting macular fixation or central visual acuity).
- Multifocal or near-infrared-blocking/heavily tinted corrective lenses: bifocal, trifocal, or progressive/varifocal lenses, or coatings that impair eye-tracking. (Single-vision glasses and contact lenses are eligible.)
Tanulási terv
Hogyan készül a tanulmány?
Tervezési részletek
- Elsődleges cél: Megelőzés
- Kiosztás: Véletlenszerűsített
- Beavatkozó modell: Párhuzamos hozzárendelés
- Maszkolás: Nincs (Open Label)
Fegyverek és beavatkozások
Résztvevő csoport / kar |
Beavatkozás / kezelés |
|---|---|
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Kísérleti: DCE exposure
Participants complete the in-person discrete choice experiment (DCE) with eye-tracking study visit immediately after randomization. During this visit, participants view 64 anti-smoking social media messages presented in 16 choice sets while their eye movements are recorded. Participants then complete an online questionnaire assessing quitting-related behaviors 2 weeks later. |
Participants will view 64 anti-smoking social media messages, presented across 16 choice sets, in a discrete choice experiment (DCE) with eye-tracking. Within each choice set, participants indicate which message most attracts their attention, which they would be most likely to share or repost, and which would most motivate them to quit smoking. |
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Nincs beavatkozás: Waitlist Control
Participants wait 2 weeks following randomization. At the start of an in-person visit conducted at the end of this waiting period, participants answer questions about quitting-related behaviors covering the preceding 2-week waiting period. Participants then complete the discrete choice experiment (DCE) with eye-tracking study. |
Mit mér a tanulmány?
Elsődleges eredményintézkedések
Eredménymérő |
Intézkedés leírása |
Időkeret |
|---|---|---|
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Quit attempts
Időkeret: 2 weeks after message exposure for the immediate intervention arm and 2 weeks before message exposure for the waitlist control arm.
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Self-reported quit attempt: Participants will be asked, "Have you made an attempt to quit smoking cigarettes in the past 2 weeks?" Response options will include yes, no, and don't know. Participants who report a quit attempt will be asked, "How long did you stop smoking?" with responses recorded as the number of days, ranging from less than 1 day to 14 days. Participants who report stopping smoking for 1 day or more will be classified as having made a quit attempt for the primary outcome analysis. |
2 weeks after message exposure for the immediate intervention arm and 2 weeks before message exposure for the waitlist control arm.
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Másodlagos eredményintézkedések
Eredménymérő |
Intézkedés leírása |
Időkeret |
|---|---|---|
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Intention to Quit
Időkeret: 2 weeks after message exposure for the immediate intervention arm and 2 weeks before message exposure for the waitlist control arm.
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Intention to quit smoking is assessed by asking participants the following questions, where 1 is not at all, and 5 is extremely: 1. How interested are you in quitting smoking in the next month? 2. How much do you plan to quit smoking in the next month and 3. How likely are you to quit smoking in the next month? |
2 weeks after message exposure for the immediate intervention arm and 2 weeks before message exposure for the waitlist control arm.
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Együttműködők és nyomozók
Szponzor
Tanulmányi rekorddátumok
Tanulmány főbb dátumok
Tanulmány kezdete (Tényleges)
Elsődleges befejezés (Becsült)
A tanulmány befejezése (Becsült)
Tanulmányi regisztráció dátumai
Először benyújtva
Először nyújtották be, amely megfelel a minőségbiztosítási kritériumoknak
Első közzététel (Tényleges)
Tanulmányi rekordok frissítései
Utolsó frissítés közzétéve (Tényleges)
Az utolsó frissítés elküldve, amely megfelel a minőségbiztosítási kritériumoknak
Utolsó ellenőrzés
Több információ
A tanulmányhoz kapcsolódó kifejezések
Kulcsszavak
További vonatkozó MeSH feltételek
Egyéb vizsgálati azonosító számok
- H26621
- R01CA289552 (Az Egyesült Államok NIH támogatása/szerződése)
Terv az egyéni résztvevői adatokhoz (IPD)
Tervezi megosztani az egyéni résztvevői adatokat (IPD)?
Gyógyszer- és eszközinformációk, tanulmányi dokumentumok
Egy amerikai FDA által szabályozott gyógyszerkészítményt tanulmányoz
Egy amerikai FDA által szabályozott eszközterméket tanulmányoz
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