- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT01335178
A Program to Protect Young Children From Tobacco Smoke Exposure
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
Goals The primary goal of this research is to develop and test a theory-based intervention which will reduce tobacco smoke exposure (TSE) of young children. A secondary goal is to increase knowledge of measurement of TSE in young children, and explore the relationship between early TSE, illness, and health care utilization. The study is being conducted in several stages: Developmental (Phase I), Pilot (Phase II), and Trial (Phase III). This registration pertains to Phase II of this trial.
Developmental Stage (Phase I)
This stage includes the following: Systematic reviews of the literature on the topics of encouraging i. parental cessation, ii.reducing child tobacco smoke exposure (TSE), and iii.reducing tobacco smoke air pollution in homes; consultations with experts worldwide; conduct of interviews with parents (n=65) and professionals (n=15) to understand parental perceptions of tobacco smoke exposure, and barriers to protection of children from TSE; and development of an initial intervention program. This stage draws on a social marketing approach and employs in-depth interviews to identify barriers to behavior change and relevant behavior-change recommendations, tailored to the intervention population, and to test the acceptability of program components.
Intervention Program
The intervention consisted of the following elements: (a) Three motivational interviews, scheduled for baseline, one month, and three months; (b) Feedback on air quality in the home (from a Sidepak and/or a Dylos monitoring device, and from passive air nicotine dosimeters); (c) Feedback on child's exposure via hair samples analyzed for nicotine; (d) a website designed especially for the project [22];and (e) various self-help materials, including a booklet, a magnet about TSE, and air fresheners.
Pilot (Phase II) A pilot of the planned intervention was conducted with 29 families. A before - and - after design was used, without a control group. The main endpoint was child exposure to tobacco smoke as measured by hair nicotine. Secondary endpoints included child exposure to tobacco smoke as measured by parental reports, family smoking in home or car, home air nicotine, child illnesses, and use of health services.
[Randomized Controlled Trial (Phase III) (Note: a separate registration number is being sought for this phase) The investigators plan to implement and evaluate the intervention using a randomized controlled trial with an estimated 120 participants. The primary response variable will be child tobacco smoke exposure as measured by hair nicotine. The control group will be offered the intervention at the end of the study (eg, a randomize-to-wait-list design). ]
An effective program for child tobacco smoke exposure reduction could serve as a prototype for reducing child tobacco smoke exposure.
Tipo de estudio
Inscripción (Actual)
Fase
- Fase 2
Contactos y Ubicaciones
Ubicaciones de estudio
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Ramat Aviv, Israel, 69978
- Tel Aviv University
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
At least one parent was a current smoker. The child was of the appropriate age (<8 years of age). The child had sufficient hair growth for hair samples. A parent gave consent for participation in the research. The parent can communicate in Hebrew.
Exclusion Criteria:
- One of above conditions not met
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Prevención
- Asignación: N / A
- Modelo Intervencionista: Asignación de un solo grupo
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Experimental: Intervention
Participants received the behavioral intervention, which was designed to motivate parents to protect their children from tobacco smoke exposure
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The intervention consisted of the following elements: (a) Three motivational interviews, scheduled for baseline, one month, and three months; (b) Feedback on air quality in the home (PM2.5 was measured using a Sidepak and/or a Dylos monitoring device, and air nicotine was measured using passive air nicotine dosimeters); (c) Feedback on child's exposure via hair nicotine; (d) a website designed especially for the project [parents.org.il];and
(e) various self-help materials, including a booklet, a magnet about TSE, and air fresheners.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Child exposure to tobacco smoke - hair nicotine
Periodo de tiempo: Baseline, 6 months post-intervention
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Child exposure to tobacco smoke as assessed by hair nicotine level
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Baseline, 6 months post-intervention
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Child exposure to tobacco smoke - parental report
Periodo de tiempo: Baseline, 6 months post-intervention
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Child exposure to tobacco smoke as measured by parental report
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Baseline, 6 months post-intervention
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Child health status
Periodo de tiempo: Baseline, 6 months post-intervention (continuous)
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Incidence of respiratory events as reported by parents
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Baseline, 6 months post-intervention (continuous)
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Respirable Small Particle (RSPs - PM2.5) level in home
Periodo de tiempo: Baseline, 1 month post-intervention
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Measurement of RSPs in the home over a 24-hour period
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Baseline, 1 month post-intervention
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Air nicotine
Periodo de tiempo: Baseline, 6 months post-intervention
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Passive nicotine dosimeters were used for 1 7-day period in the home
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Baseline, 6 months post-intervention
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Laura J Rosen, PhD, Tel Aviv University
Publicaciones y enlaces útiles
Publicaciones Generales
- Rosen LJ, Noach MB, Winickoff JP, Hovell MF. Parental smoking cessation to protect young children: a systematic review and meta-analysis. Pediatrics. 2012 Jan;129(1):141-52. doi: 10.1542/peds.2010-3209. Epub 2011 Dec 26.
- Rosen LJ, Guttman N, Hovell MF, Noach MB, Winickoff JP, Tchernokovski S, Rosenblum JK, Rubenstein U, Seidmann V, Vardavas CI, Klepeis NE, Zucker DM. Development, design, and conceptual issues of project zero exposure: A program to protect young children from tobacco smoke exposure. BMC Public Health. 2011 Jun 28;11:508. doi: 10.1186/1471-2458-11-508.
- Rosen LJ, Myers V, Hovell M, Zucker D, Ben Noach M. Meta-analysis of parental protection of children from tobacco smoke exposure. Pediatrics. 2014 Apr;133(4):698-714. doi: 10.1542/peds.2013-0958. Epub 2014 Mar 24.
- Rosen LJ, Tillinger E, Guttman N, Rosenblat S, Zucker DM, Stillman F, Myers V. Parental receptivity to child biomarker testing for tobacco smoke exposure: A qualitative study. Patient Educ Couns. 2015 Nov;98(11):1439-45. doi: 10.1016/j.pec.2015.05.023. Epub 2015 Jun 9.
- Rosen L, Zucker D, Hovell M, Brown N, Ram A, Myers V. Feasibility of Measuring Tobacco Smoke Air Pollution in Homes: Report from a Pilot Study. Int J Environ Res Public Health. 2015 Nov 30;12(12):15129-42. doi: 10.3390/ijerph121214970.
- Rosen L, Guttman N, Myers V, Brown N, Ram A, Hovell M, Breysse P, Rule A, Berkovitch M, Zucker D. Protecting Young Children From Tobacco Smoke Exposure: A Pilot Study of Project Zero Exposure. Pediatrics. 2018 Jan;141(Suppl 1):S107-S117. doi: 10.1542/peds.2017-1026N.
- Rosen LJ, Lev E, Guttman N, Tillinger E, Rosenblat S, Zucker DM, Myers V. Parental Perceptions and Misconceptions of Child Tobacco Smoke Exposure. Nicotine Tob Res. 2018 Sep 25;20(11):1369-1377. doi: 10.1093/ntr/ntx169.
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 (Estimar)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Otros números de identificación del estudio
- FAMRI-072086_YCSA
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