- ICH GCP
- US-Register für klinische Studien
- Klinische Studie NCT01335178
A Program to Protect Young Children From Tobacco Smoke Exposure
Studienübersicht
Status
Bedingungen
Intervention / Behandlung
Detaillierte Beschreibung
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.
Studientyp
Einschreibung (Tatsächlich)
Phase
- Phase 2
Kontakte und Standorte
Studienorte
-
-
-
Ramat Aviv, Israel, 69978
- Tel Aviv University
-
-
Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Beschreibung
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
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Verhütung
- Zuteilung: N / A
- Interventionsmodell: Einzelgruppenzuweisung
- Maskierung: Keine (Offenes Etikett)
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
|---|---|
|
Experimental: Intervention
Participants received the behavioral intervention, which was designed to motivate parents to protect their children from tobacco smoke exposure
|
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.
|
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Child exposure to tobacco smoke - hair nicotine
Zeitfenster: Baseline, 6 months post-intervention
|
Child exposure to tobacco smoke as assessed by hair nicotine level
|
Baseline, 6 months post-intervention
|
Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Child exposure to tobacco smoke - parental report
Zeitfenster: Baseline, 6 months post-intervention
|
Child exposure to tobacco smoke as measured by parental report
|
Baseline, 6 months post-intervention
|
|
Child health status
Zeitfenster: Baseline, 6 months post-intervention (continuous)
|
Incidence of respiratory events as reported by parents
|
Baseline, 6 months post-intervention (continuous)
|
|
Respirable Small Particle (RSPs - PM2.5) level in home
Zeitfenster: Baseline, 1 month post-intervention
|
Measurement of RSPs in the home over a 24-hour period
|
Baseline, 1 month post-intervention
|
|
Air nicotine
Zeitfenster: Baseline, 6 months post-intervention
|
Passive nicotine dosimeters were used for 1 7-day period in the home
|
Baseline, 6 months post-intervention
|
Mitarbeiter und Ermittler
Sponsor
Ermittler
- Hauptermittler: Laura J Rosen, PhD, Tel Aviv University
Publikationen und hilfreiche Links
Allgemeine Veröffentlichungen
- 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.
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn
Primärer Abschluss (Tatsächlich)
Studienabschluss (Tatsächlich)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Schätzen)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Schätzen)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Andere Studien-ID-Nummern
- FAMRI-072086_YCSA
Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .
Klinische Studien zur Intervention
-
University of FloridaAbgeschlossenEmpfindlichkeitVereinigte Staaten
-
Universidad de ExtremaduraDiputación Provincial de BadajozRekrutierungGesundheitserziehung | Gamification in der GesundheitserziehungSpanien
-
Case Western Reserve UniversityAktiv, nicht rekrutierend
-
Faculdade de Motricidade HumanaFundação para a Ciência e a Tecnologia (FCT)Noch keine Rekrutierung
-
University of WashingtonNational Cancer Institute (NCI)AbgeschlossenMelanom | Lymphom | Gebärmutterhalskrebs | Leukämie | Brustkrebs | Darmkrebs | Darmkrebs | Bösartige NeubildungVereinigte Staaten
-
Rabin Medical CenterAcademic College of Tel Aviv-Jaffa; Israel Cancer AssociationUnbekanntEierstockkrebs | Krebs des Gebärmutterhalses | Krebs des EndometriumsIsrael
-
University of Kansas Medical CenterAbgeschlossen
-
Cairo UniversityNoch keine RekrutierungGenauigkeit verschiedener Scantechniken
-
Biolux Research Holdings, Inc.BeendetKieferorthopädische ZahnbewegungKanada
-
University MariborAbgeschlossenHerzkrankheiten | Herz-Kreislauf-Erkrankungen | Koronare Herzkrankheit | Koronare Herzerkrankung | Lebensstil | Kontinuierliche Glukoseüberwachung | Verhaltensänderung | CGM | Visuelle AnalyseSlowenien