- ICH GCP
- Registro de ensaios clínicos dos EUA
- Ensaio Clínico 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.
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Tipo de estudo
Inscrição (Estimado)
Estágio
- Não aplicável
Contactos e Locais
Contato de estudo
- Nome: Shivani Gaiha, PhD
- Número de telefone: 617-355-3538
- E-mail: Shivani.Gaiha@childrens.harvard.edu
Estude backup de contato
- Nome: Madison O'Connell
- Número de telefone: 617-919-6964
- E-mail: madison.oconnell@childrens.harvard.edu
Locais de estudo
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Massachusetts
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Boston, Massachusetts, Estados Unidos, 02115
- Boston Children's Hospital
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Contato:
- Shivani Gaiha, PhD
- Número de telefone: 617-355-3538
- E-mail: shivani.gaiha@childrens.harvard.edu
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-
Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Descrição
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)
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Prevenção
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Solteiro
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
|
Experimental: 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. |
|
Comparador Ativo: 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. |
|
Outro: 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. |
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Susceptibility to use e-cigarettes among those who never used
Prazo: 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).
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
E-cigarette Use
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: Day 1 (Baseline/Pre-intervention)
|
Questions to assess social media use, frequency, and platforms. |
Day 1 (Baseline/Pre-intervention)
|
|
Anti-vaping content exposure
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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)
|
Outras medidas de resultado
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Recruitment, enrollment, and attrition
Prazo: 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
Prazo: 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)
|
Colaboradores e Investigadores
Patrocinador
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Estimado)
Conclusão Primária (Estimado)
Conclusão do estudo (Estimado)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- 26-504
- R00CA267477 (Concessão/Contrato do NIH dos EUA)
Plano para dados de participantes individuais (IPD)
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