- ICH GCP
- Registre américain des essais cliniques
- Essai clinique 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.
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Type d'étude
Inscription (Estimé)
Phase
- N'est pas applicable
Contacts et emplacements
Coordonnées de l'étude
- Nom: Shivani Gaiha, PhD
- Numéro de téléphone: 617-355-3538
- E-mail: Shivani.Gaiha@childrens.harvard.edu
Sauvegarde des contacts de l'étude
- Nom: Madison O'Connell
- Numéro de téléphone: 617-919-6964
- E-mail: madison.oconnell@childrens.harvard.edu
Lieux d'étude
-
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Massachusetts
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Boston, Massachusetts, États-Unis, 02115
- Boston Children's Hospital
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Contact:
- Shivani Gaiha, PhD
- Numéro de téléphone: 617-355-3538
- E-mail: shivani.gaiha@childrens.harvard.edu
-
-
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
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)
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: La prévention
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Seul
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: 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. |
|
Comparateur actif: 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. |
|
Autre: 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. |
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Susceptibility to use e-cigarettes among those who never used
Délai: 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).
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
E-cigarette Use
Délai: 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
Délai: 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
Délai: 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
Délai: 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)
|
|
Marketing exposure on social media
Délai: Day 1 (Baseline/Pre-intervention)
|
Questions to assess social media use, frequency, and platforms. |
Day 1 (Baseline/Pre-intervention)
|
|
Anti-vaping content exposure
Délai: 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)
|
|
Knowledge of e-cigarette retail marketing
Délai: 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
Délai: 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)
|
|
Video acceptability
Délai: 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)
|
Autres mesures de résultats
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Recruitment, enrollment, and attrition
Délai: 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)
|
|
Video feasibility
Délai: 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)
|
Collaborateurs et enquêteurs
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Estimé)
Achèvement primaire (Estimé)
Achèvement de l'étude (Estimé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- 26-504
- R00CA267477 (Subvention/contrat des NIH des États-Unis)
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
Informations sur les médicaments et les dispositifs, documents d'étude
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