Enhancing Source Credibility in Tobacco Regulatory Communications
20 de novembro de 2020 atualizado por: Adam Goldstein, MD, MPH, UNC Lineberger Comprehensive Cancer Center
This study will assess the impact of cigarette constituent messages with and without FDA source and quit information in a randomized controlled trial.
The investigators hypothesize that cigarette constituent messages will increase intention to quit compared to messages about littering cigarettes (the control).
The investigators also hypothesize that constituent messages that include FDA source and quit information will increase intention to quit compared to messages without that information.
Visão geral do estudo
Status
Concluído
Condições
Descrição detalhada
The Family Smoking Prevention and Tobacco Control Act delegates the U.S. Food and Drug Administration (FDA) to communicate the risks of smoking to the public, among other tobacco regulatory responsibilities. Little research exists about how FDA, as a regulatory agency, should develop and deliver these messages, and whether they should include their source information on the ads. This study will assess the impact of cigarette constituent messages with and without FDA source and quit information in a randomized controlled trial.
Recruitment: People interested in participating will complete an online screener. Study staff will invite people eligible based on the screener to enroll in the study.
Informed Consent: The consent form will be shared with people who are eligible based on the screener in the invitation email. At the beginning of the baseline survey, participants will again review the consent form and will be asked to provide consent in order to enroll in the study.
Randomization: At the end of the baseline survey, survey software will randomly assign participants to one of the three study arms. Participants will have an equal chance of being randomized to each study arm.
Assessment: Participants will complete 18 computer based surveys during the study. The first baseline survey will take around 20 minutes to complete on day 0. Participants will then receive a survey each morning for days 1-15 that will include behavior measures as well as their assigned study intervention. These surveys will take approximately 5 minutes to complete. Participants will then complete a 20-minute survey on day 16, and day 32.
Detailed description of the intervention: Participants will receive an email with a link to a survey each morning for 15 days. During that survey they will be shown one message from their condition. Each condition has 5 messages that will be repeated 3 times in a counterbalanced order. Study investigators designed the messages.
Tipo de estudo
Intervencional
Inscrição (Real)
845
Estágio
- Não aplicável
Contactos e Locais
Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.
Locais de estudo
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North Carolina
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Chapel Hill, North Carolina, Estados Unidos, 27599
- University of North Carolina At Chapel Hill
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Critérios de participação
Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.
Critérios de elegibilidade
Idades elegíveis para estudo
18 anos a 65 anos (Adulto, Adulto mais velho)
Aceita Voluntários Saudáveis
Não
Gêneros Elegíveis para o Estudo
Tudo
Descrição
Inclusion Criteria:
- Have smoked at least 100 cigarettes in his or her lifetime
- Currently smoke cigarettes every day or some days
- Work or home access to the internet
- Email account that is regularly used
- Lives in the US
- Comfortable taking a survey in English
- Able to complete a survey on a computer
- Able to complete surveys delivered via email
- Able to complete 3, 20 minute surveys during the study
- Able to complete surveys in the morning for 15 days
Exclusion Criteria:
- Currently using pharmacotherapy, a quitline, or a quit smoking program or support group for smoking cessation
- Participated in a research study about smoking cigarettes or using other tobacco products in the last 3 months
Plano de estudo
Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Prevenção
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
|
Experimental: Constituent message with FDA and quitline
Messages about the chemical constituents of cigarette smoke will include text about chemicals in cigarette smoke and health effects of the chemicals, and an image of a person related to the health effect.
This arm will also include an FDA logo, and information about the benefits of quitting smoking and the quitline.
Each condition has 5 messages that will be repeated 3 times in a counterbalanced order.
Study investigators used text developed by investigators associated with our Center for Regulatory Research on Tobacco Communication.
Design of these messages was developed by our team.
|
Messages about the chemical constituents of cigarette smoke will include text about chemicals in cigarette smoke and health effects of the chemicals, and an image of a person related to the health effect.
This arm will also include an FDA logo, and information about the benefits of quitting smoking and the quitline.
Each condition has 5 messages that will be repeated 3 times in a counterbalanced order.
Study investigators used text developed by investigators associated with our Center for Regulatory Research on Tobacco Communication.
Design of these messages was developed by our team.
|
|
Experimental: Constituent message without FDA and quitline
Messages about the chemical constituents of cigarette smoke will include text about chemicals in cigarette smoke and health effects of the chemicals, and an image of a person related to the health effect.
This arm is identical to the arm above, except that it does not include FDA source or quit information.
Each condition has 5 messages that will be repeated 3 times in a counterbalanced order.
Study investigators used text developed by investigators associated with our Center for Regulatory Research on Tobacco Communication.
Design of these messages was developed by our team.
|
Messages about the chemical constituents of cigarette smoke will include text about chemicals in cigarette smoke and health effects of the chemicals, and an image of a person related to the health effect.
This arm is identical to the arm above, except that it does not include FDA source or quit information.
Each condition has 5 messages that will be repeated 3 times in a counterbalanced order.
Study investigators used text developed by investigators associated with our Center for Regulatory Research on Tobacco Communication.
Design of these messages was developed by our team.
|
|
Outro: Littering message (Control)
Messages about littering cigarettes will include text designed to discourage people from littering their cigarette butts, and an image related to the message.
Each condition has 5 messages that will be repeated 3 times in a counterbalanced order.
Study investigators used text developed by investigators associated with our Center for Regulatory Research on Tobacco Communication.
Design of these messages was developed by our team.
|
Messages about littering cigarettes will include text designed to discourage people from littering their cigarette butts, and an image related to the message.
Each condition has 5 messages that will be repeated 3 times in a counterbalanced order.
Study investigators used text developed by investigators associated with our Center for Regulatory Research on Tobacco Communication.
Design of these messages was developed by our team.
|
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Quit Intentions
Prazo: day 16
|
Average quit intention score measured at 16 days by survey.
Quit intention measured with 3 questions, the final quit intention score is a mean of the response to the 3 questions, on a scale of 1 to 4, where 1 indicates low intention to quit, and 4 indicates a high intention to quit.
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day 16
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Number of Cigarettes Smoked Each Day
Prazo: days 1-15
|
Measured daily by survey
|
days 1-15
|
|
Number of Cigarettes Forgone Each Day
Prazo: days 1-15
|
Measured daily by survey
|
days 1-15
|
|
Number of Cigarettes Butted Out Each Day
Prazo: days 1-15
|
Measured daily by survey
|
days 1-15
|
|
Quit Attempts During the Study
Prazo: days 16 and 32
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Measured by survey
|
days 16 and 32
|
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Awareness of Quitline
Prazo: day 16
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Measured by survey
|
day 16
|
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Recall of Quitline Phone Number
Prazo: day 16
|
Measured by survey
|
day 16
|
|
Use of Quitline During the Study
Prazo: days 16 and 32
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Measured by survey
|
days 16 and 32
|
|
Intention to Use the Quitline
Prazo: days 16 and 32
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Measured by survey.
Intention to use the quitline was measured with one item on a 1 to 4 scale, where 1 indicates a low likelihood of calling the quitline, and 4 indicates a high likelihood of calling the quitline.
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days 16 and 32
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Quit Intentions
Prazo: day 32
|
Average quit intention score measured at 32 days by survey.
Quit intention measured with 3 questions, the final quit intention score is a mean of the response to the 3 questions, on a scale of 1 to 4, where 1 indicates low intention to quit, and 4 indicates a high intention to quit.
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day 32
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Self Efficacy
Prazo: days 16 and 32
|
Measured by survey.
Self efficacy measured with 1 question, on a scale of 1 to 5, where 1 indicates low self efficacy to quit, and 5 indicates a high self efficacy to quit smoking cigarettes.
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days 16 and 32
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Response Efficacy
Prazo: days 16 and 32
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Measured by survey.
Response efficacy measured with 1 question, on a scale of 1 to 5, where 1 indicates low response efficacy of quitting, and 5 indicates a high response efficacy of quitting smoking cigarettes.
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days 16 and 32
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Colaboradores e Investigadores
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
Colaboradores
Publicações e links úteis
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Datas de registro do estudo
Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.
Datas Principais do Estudo
Início do estudo (Real)
10 de outubro de 2017
Conclusão Primária (Real)
6 de maio de 2018
Conclusão do estudo (Real)
23 de maio de 2018
Datas de inscrição no estudo
Enviado pela primeira vez
7 de novembro de 2017
Enviado pela primeira vez que atendeu aos critérios de CQ
7 de novembro de 2017
Primeira postagem (Real)
13 de novembro de 2017
Atualizações de registro de estudo
Última Atualização Postada (Real)
24 de novembro de 2020
Última atualização enviada que atendeu aos critérios de controle de qualidade
20 de novembro de 2020
Última verificação
1 de novembro de 2020
Mais Informações
Termos relacionados a este estudo
Outros números de identificação do estudo
- 17-0610
- P50CA180907 (Concessão/Contrato do NIH dos EUA)
Informações sobre medicamentos e dispositivos, documentos de estudo
Estuda um medicamento regulamentado pela FDA dos EUA
Não
Estuda um produto de dispositivo regulamentado pela FDA dos EUA
Não
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