- ICH GCP
- Registr klinických studií v USA
- Klinická studie NCT07934875
Understanding Vape Counter-Marketing Study
Countering E-Cigarette Marketing in the Retail Environment Among Adolescents and Young Adults
The goal of this interventional study is to test whether short videos of electronic-cigarette (e-cigarette) counter-marketing lessons work to decrease people's intent to use and smoke e-cigarettes. Using short videos, the investigators hope to inform participants about the marketing strategies that e-cigarette companies use to try to get people to purchase and use e-cigarettes. The investigators hope to find that, after watching the short videos, people will be able to point out when e-cigarette companies are trying to sell their products, and hopefully they will have a lower interest in buying and using e-cigarettes. The investigators also hope participants will learn more about the addictiveness and harmfulness of using e-cigarettes by watching the short videos.
Přehled studie
Postavení
Podmínky
Typ studie
Zápis (Odhadovaný)
Fáze
- Nelze použít
Kontakty a umístění
Studijní kontakt
- Jméno: Shivani Gaiha, PhD
- Telefonní číslo: 617-355-3538
- E-mail: Shivani.Gaiha@childrens.harvard.edu
Studijní záloha kontaktů
- Jméno: Madison O'Connell
- Telefonní číslo: 617-919-6964
- E-mail: madison.oconnell@childrens.harvard.edu
Studijní místa
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Massachusetts
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Boston, Massachusetts, Spojené státy, 02115
- Boston Children's Hospital
-
Kontakt:
- Shivani Gaiha, PhD
- Telefonní číslo: 617-355-3538
- E-mail: shivani.gaiha@childrens.harvard.edu
-
-
Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
Přijímá zdravé dobrovolníky
Pohlaví způsobilá ke studiu
Popis
Inclusion Criteria:
- 13-21 years old
- Fluent in English
- Owns a smartphone or other device that can be used to complete study activities (e.g., watching videos, responding to electronic surveys)
- Meets sampling ratio to match the US Census for sex assigned at birth, race, and ethnicity
Exclusion Criteria:
- Fails survey validation checks (e.g., completing the survey too quickly, providing the same answer to every question)
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Prevence
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Singl
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
|---|---|
|
Experimentální: New Intervention Group
Participants in this arm will receive a novel intervention developed by the study team. |
Participants will view 4 short-form videos filmed by influencers. Influencers convey messaging designed to counter e-cigarette marketing in retail stores. |
|
Aktivní komparátor: Pre-existing Intervention
Participants will receive a comparable, pre-existing intervention not developed by the study team. |
Participants will view 1 video in the public domain with messaging on e-cigarette marketing tactics. |
|
Jiný: Control Condition
Participants will receive a control condition that was not developed by the study team. |
Participants will view 4 short-form influencer-generated videos on topics that are unrelated to counter e-cigarette marketing in retail stores. |
Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Susceptibility to use e-cigarettes among those who never used
Časové okno: From Day 1 (Baseline/Pre-intervention) to Day 31 (One-month follow-up after the treatment).
|
Susceptibility to use e-cigarettes among those who never used [Susceptibility scores are calculated based on the following 4 items:
O'Brien EK, Baig SA, Persoskie A. Developing and Validating Measures of Absolute and Relative E-Cigarette Product Risk Perceptions: Single Items Can Be Surprisingly Comprehensive. Nicotine Tob Res. 2022;24(3):316-323. doi:10.1093/ntr/n |
From Day 1 (Baseline/Pre-intervention) to Day 31 (One-month follow-up after the treatment).
|
Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
E-cigarette Use
Časové okno: From Day 1 (Baseline/Pre-intervention) to Day 31 (One-month follow-up after the treatment).
|
|
From Day 1 (Baseline/Pre-intervention) to Day 31 (One-month follow-up after the treatment).
|
|
Intent to use e-cigarettes and cigarettes
Časové okno: From Day 1 (Baseline/Pre-intervention); Day 1 (Immediately Post-intervention); and Day 31 (One-month follow-up after the treatment)
|
Do participants plan to use e-cigarettes and cigarettes? |
From Day 1 (Baseline/Pre-intervention); Day 1 (Immediately Post-intervention); and Day 31 (One-month follow-up after the treatment)
|
|
Vaping attitudes and norms
Časové okno: From Day 1 (Baseline/Pre-intervention); Day 1 (Immediately Post-intervention); and Day 31 (One-month follow-up after the treatment)
|
We will measure people's attitudes and acceptance towards vaping using: Vaping Attitudes Scale (5-point Likert-type; high score: positive attitude) and Mean Vaping Injunctive Norms Scale (3-item) |
From Day 1 (Baseline/Pre-intervention); Day 1 (Immediately Post-intervention); and Day 31 (One-month follow-up after the treatment)
|
|
Pro-vaping marketing exposure (focused on retail), including marketing receptivity
Časové okno: From Day 1 (Baseline/Pre-intervention) Day 31 (One-month follow-up after the treatment)
|
Can people understand and recognize e-cigarette marketing? Does it have an effect on them? |
From Day 1 (Baseline/Pre-intervention) Day 31 (One-month follow-up after the treatment)
|
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Marketing exposure on social media
Časové okno: Day 1 (Baseline/Pre-intervention)
|
Questions to assess social media use, frequency, and platforms. |
Day 1 (Baseline/Pre-intervention)
|
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Anti-vaping content exposure
Časové okno: Day 1 (Baseline/Pre-intervention)
|
Prior exposure to having seen content that dissuades people from using vapes and locations where they saw it. |
Day 1 (Baseline/Pre-intervention)
|
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Knowledge of e-cigarette retail marketing
Časové okno: From Day 1 (Baseline/Pre-intervention); Day 1 (Immediately Post-intervention); and Day 31 (One-month follow-up after the treatment)
|
How much do people know about e-cigarette retail marketing (based on key messages and facts shown in video content)? |
From Day 1 (Baseline/Pre-intervention); Day 1 (Immediately Post-intervention); and Day 31 (One-month follow-up after the treatment)
|
|
Perceived message effectiveness
Časové okno: Day 1 (Immediately post-intervention)
|
We will test the effectiveness of the videos using two scales, the Message Assessment Scale for Tobacco Prevention Campaigns, and the Perceived Message Effectiveness Scale (6-item). |
Day 1 (Immediately post-intervention)
|
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Video acceptability
Časové okno: Day 1 (Immediately post-treatment)
|
We will test how much people enjoyed and connected with the videos based on a quality rating scale and a question on alternative ways to receive content. |
Day 1 (Immediately post-treatment)
|
Další výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Recruitment, enrollment, and attrition
Časové okno: From Day 1 (Baseline/Pre-intervention); Day 1 (Immediately Post-intervention); and Day 31 (One-month follow-up after the treatment)
|
We want to measure recruitment and enrollment success, and how many people complete the study. |
From Day 1 (Baseline/Pre-intervention); Day 1 (Immediately Post-intervention); and Day 31 (One-month follow-up after the treatment)
|
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Video feasibility
Časové okno: Day 1 (Immediately post-intervention)
|
We want to test whether people were able to watch the videos, how many of them they watched and for how long, and what devices they used to watch them. |
Day 1 (Immediately post-intervention)
|
Spolupracovníci a vyšetřovatelé
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Odhadovaný)
Primární dokončení (Odhadovaný)
Dokončení studie (Odhadovaný)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Klíčová slova
Další relevantní podmínky MeSH
Další identifikační čísla studie
- 26-504
- R00CA267477 (Grant/smlouva NIH USA)
Plán pro data jednotlivých účastníků (IPD)
Plánujete sdílet data jednotlivých účastníků (IPD)?
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