Smoking Cessation for Young Adult Pacific Islanders: Motivating Pacifika Against Cigarettes and Tobacco (MPACT)
2 de agosto de 2017 atualizado por: Claremont Graduate University
Weaving an Islander Network for Cancer Awareness, Research and Training (WINCART): Technology & Smoking Cessation for Late Adolescent/Young Adult Pacific Islanders
The current study aimed to test a culturally tailored program designed to help Pacific Islanders (PIs) between the ages of 18 and 30 quit smoking cigarettes by using a randomized controlled trial design with one intervention group and one control group.
Visão geral do estudo
Status
Concluído
Intervenção / Tratamento
Descrição detalhada
This randomized control trial (RCT) consisted of a baseline assessment (Wave 0) and three follow-up assessments (Waves 1-3). Follow-up assessments were conducted at 2 months, 5 months, and 8 months after the baseline assessment. The objective of the study was to test a culturally-tailored online program designed to help PI young adults quit smoking cigarettes. The online program contained (1) personalized, automated text messages, (2) interactive, online educational modules, and (3) an online forum.
Hypotheses for this study include:
- Participants in the intervention program tailored to PIs would have significantly higher rates of abstinence, lower rates of relapse, and lower smoking frequency and intensity at each follow-up time point than those in the standard intervention program.
- Participants with impaired affective decision capacity (low scores on Iowa Gambling Task (IGT)) would benefit more from the tailored intervention program than participants with normal affective decision capacity (high IGT scores).
- Effects from the tailored intervention program would be more pronounced among participants with particular dispositional phenotypes (depression, hostility, impulsivity) and baseline severity of tobacco addiction (nicotine dependence).
- High-intensity users of the tailored intervention program would be more successful than low intensity users in reducing the frequency and intensity of cigarettes smoked.
- The tailored intervention program would have greater success at engaging and retaining participants than the standard intervention program.
Tipo de estudo
Intervencional
Inscrição (Real)
278
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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California
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Claremont, California, Estados Unidos, 91711
- Claremont Graduate University
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Fullerton, California, Estados Unidos, 92831
- California State University Fullerton
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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 30 anos (Adulto)
Aceita Voluntários Saudáveis
Sim
Gêneros Elegíveis para o Estudo
Tudo
Descrição
Inclusion Criteria:
- Self-identified as Native Hawaiian or Pacific Islander
- Between the ages 18 and 30
- Lived in Southern California
- Would be living in Southern California for the next year
- Owned a cell phone with a text messaging plan
- Had access to a computer with internet for at least 2 hours per week
- Smoked daily or most days of the week (>3 days)
- Smoked at least 100 cigarettes in lifetime
Exclusion Criteria:
• Was currently using another smoking cessation method
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 |
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Experimental: Intervention
The intervention entitled Motivating Pacifika Against Cigarettes and Tobacco (MPACT) was implemented for eight weeks starting on the quit date that the participant chose with their assigned coach during the baseline assessment.
At the baseline assessment, each participant watched an introductory video that described the online smoking cessation program.
The online program was accessed through the participant's Facebook account.
The program included eight education modules and a forum.
Participants also received automated daily text messages to provide support and encouragement during the quitting process.
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Participants received one encouraging text message per day prior to their quit date. During the intervention, they received daily text messages with decreasing frequency per week. Participants were also able to craft personal text messages. On-demand text messages were optional and could be requested by texting key words to the program hotline. The online MPACT program allowed participants to access eight educational modules and a forum where they could communicate with other participants. The modules focused on different aspects of quitting smoking, such as how to deal with withdrawal symptoms, triggers of tobacco use, and stress. Participants were limited to one module per day in order to increase the duration of exposure to the program. Upon completion, participants no longer received text messages but they were still able to access the educational modules, forum, and on-demand text messages.
Outros nomes:
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Sem intervenção: Control
Participants in the control group set a quit date within two weeks of their baseline assessment and watched an introductory video that described the smoking cessation program.
They received one text message every other week over a period of eight weeks following the quit date.
The messages were delivered by a web-based system not connected to the online intervention program.
Participants were also given a handout listing local tobacco cessation and education resources, a link to a generic online smoking cessation program, a fact sheet on smoking and tobacco use among PI young adults, and a quit kit containing chewing gum and a stress ball.
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Number of cigarettes smoked in last 30 days
Prazo: 8 months
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How many cigarettes has the participant smoked in the last 30 days?
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8 months
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Cigarette smoked in past 7 days
Prazo: 8 months
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Has the participant smoked a cigarette in the past 7 days?
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8 months
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Cigarette smoked in past 24 hours
Prazo: 8 months
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Has the participant smoked a cigarette in the past 24 hours?
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8 months
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Expired carbon monoxide (CO)
Prazo: 8 months
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Biomarker validation (expired CO) of self-reported tobacco use
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8 months
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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Number of cigarettes smoked in last 30 days
Prazo: 2 months
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How many cigarettes has the participant smoked in the last 30 days?
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2 months
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Number of cigarettes smoked in last 30 days
Prazo: 5 months
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How many cigarettes has the participant smoked in the last 30 days?
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5 months
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Cigarette smoked in past 7 days
Prazo: 2 months
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Has the participant smoked a cigarette in the past 7 days?
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2 months
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Cigarette smoked in past 7 days
Prazo: 5 months
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Has the participant smoked a cigarette in the past 7 days?
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5 months
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Cigarette smoked in past 24 hours
Prazo: 2 months
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Has the participant smoked a cigarette in the past 24 hours?
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2 months
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Cigarette smoked in past 24 hours
Prazo: 5 months
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Has the participant smoked a cigarette in the past 24 hours?
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5 months
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Expired carbon monoxide (CO)
Prazo: 2 months
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Biomarker validation (expired CO) of self-reported tobacco use
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2 months
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Expired carbon monoxide (CO)
Prazo: 5 months
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Biomarker validation (expired CO) of self-reported tobacco use
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5 months
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Colaboradores e Investigadores
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
Colaboradores
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)
11 de julho de 2013
Conclusão Primária (Real)
3 de dezembro de 2014
Conclusão do estudo (Real)
31 de maio de 2015
Datas de inscrição no estudo
Enviado pela primeira vez
21 de julho de 2017
Enviado pela primeira vez que atendeu aos critérios de CQ
1 de agosto de 2017
Primeira postagem (Real)
3 de agosto de 2017
Atualizações de registro de estudo
Última Atualização Postada (Real)
4 de agosto de 2017
Última atualização enviada que atendeu aos critérios de controle de qualidade
2 de agosto de 2017
Última verificação
1 de agosto de 2017
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Outros números de identificação do estudo
- U54CA153458 (Concessão/Contrato do NIH dos EUA)
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
SIM
Descrição do plano IPD
De-identified datasets with individual participant data will be provided by the Principal Investigator upon request.
All data sharing requests will be reviewed and approved by the Office of Research and Sponsored Programs at Claremont Graduate University and the WINCART2 Center Steering Committee.
Informações sobre medicamentos e dispositivos, documentos de estudo
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Não
Estuda um produto de dispositivo regulamentado pela FDA dos EUA
Não
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