- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo 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
Descripción general del estudio
Estado
Condiciones
Descripción detallada
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 estudio
Inscripción (Actual)
Fase
- Fase 2
Contactos y Ubicaciones
Ubicaciones de estudio
-
-
Alaska
-
Anchorage, Alaska, Estados Unidos, 99577
- Alaska Native Tribal Health Consortium
-
-
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
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.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Comparador activo: Control condition
Control behavioral phone-based smoking cessation intervention
|
phone-based behavioral smoking cessation counseling
|
|
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
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
smoking abstinence in late pregnancy (self-reported abstinence verified with cotinine)
Periodo de tiempo: at week 36 gestation or greater up to the time of delivery
|
self-reported abstinence verified with cotinine
|
at week 36 gestation or greater up to the time of delivery
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Self-efficacy (Self-reported confidence scale)
Periodo de tiempo: 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
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Estimar)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 11-001144-02
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
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