- ICH GCP
- Registro de ensaios clínicos dos EUA
- Ensaio Clínico NCT02431611
Biomarker Feedback to Motivate Cessation in Pregnancy (MAW Phase 3)
Biomarker Feedback to Motivate Tobacco Cessation in Pregnant Alaska Native Women (MAW) - Phase 3 Pilot Clinical Trial
Visão geral do estudo
Status
Condições
Descrição detalhada
Developing effective tobacco cessation interventions during pregnancy for American Indian and Alaska Native people is a national priority and will contribute to the U.S. public health objective of reducing tobacco-related cancer health disparities. The proposed project builds on the investigators' successful partnership with the Alaska Native community and previous work with Alaska Native pregnant women. The investigators propose to develop and test a novel biomarker feedback intervention relating cotinine levels in the urine of pregnant women with the woman and infant's likely exposure to the tobacco specific nitrosamine and carcinogen 4-(methylnitrosamino)-1-(3-pyridyl)-1-butanone) (NNK). This 5-year project will be conducted in three phases. In Phase 1 the investigators will utilize a non-randomized, clinical observational trial to examine biomarkers of nicotine and carcinogen exposure (urine cotinine and total NNAL [a metabolite of NNK], respectively) among 150 maternal-infant pairs with assessments conducted during pregnancy and at delivery. In Phase 2, the investigators will obtain qualitative feedback on the findings from Phase 1 through individual interviews conducted with 32 women who use tobacco to develop the biomarker feedback intervention messages. Phase 3 will consist of a formative evaluation of the biomarker feedback intervention with 60 pregnant women using a two-group randomized design to assess the intervention's feasibility and acceptability, and the biochemically confirmed abstinence rate at the end of pregnancy. All phases of the project will be guided by a Community Advisory Committee. Each phase is an important step to advance the investigators' understanding of the potential for biomarker feedback as a strategy to help Alaska Native pregnant women quit tobacco use. The potential reach of the intervention is significant from a public health perspective as over 600 tobacco users deliver each year at the Alaska Native Medical Center in Anchorage where the proposed project will take place. Developing effective interventions for tobacco cessation during pregnancy is important to reduce adverse health consequences for the mother and neonate and future risk of tobacco-caused cancers.
This is the third and final phase of the project.
Tipo de estudo
Inscrição (Real)
Estágio
- Fase 2
Contactos e Locais
Locais de estudo
-
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Alaska
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Anchorage, Alaska, Estados Unidos, 99577
- Alaska Native Tribal Health Consortium
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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:
- Alaska Native
- 18 years or older
- provide written informed consent
- be currently pregnant and at <24 weeks gestation
- reside in Anchorage and plan to deliver at the ANMC
- current tobacco user defined as any use of Iqmik, commercial ST, and/or cigarettes during the past 7 days.
Exclusion Criteria:
- use of using nicotine replacement therapy or medications for tobacco cessation or participation in a behavioral cessation program within the past 30 days
- another woman from the same household has enrolled.
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
|
Comparador Ativo: Control condition
Control behavioral phone-based smoking cessation intervention
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phone-based behavioral smoking cessation counseling
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Experimental: Biomarker Feedback Intervention
Biomarker feedback plus behavioral phone-based smoking cessation intervention
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Feedback on maternal cotinine and likely infant NNAL Phone based behavioral smoking cessation counseling
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
smoking abstinence in late pregnancy (self-reported abstinence verified with cotinine)
Prazo: at week 36 gestation or greater up to the time of delivery
|
self-reported abstinence verified with cotinine
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at week 36 gestation or greater up to the time of delivery
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Self-efficacy (Self-reported confidence scale)
Prazo: at week 36 gestation or greater up to the time of delivery
|
Self-reported confidence scale
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at week 36 gestation or greater up to the time of delivery
|
Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Christi A Patten, PhD, Mayo Clinic
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo
Conclusão Primária (Real)
Conclusão do estudo (Real)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Estimativa)
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
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- 11-001144-02
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
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