A Program to Protect Young Children From Tobacco Smoke Exposure

NCT01335178 | Completed Phase 2

• 1 other identifier: FAMRI-072086_YCSA
• Study Type: interventional
• Target: 29
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this research project is to develop and evaluate an intervention to reduce young child tobacco smoke exposure

Conditions

Child Exposure to Tobacco Smoke

Keywords

Tobacco smoke exposure; Secondhand smoke exposure; Passive smoking; Child health; Prevention; Tobacco control; Motivational Interviewing; Air quality; Pilot Study

Outcome Measures

Primary Outcomes (1)

• Child exposure to tobacco smoke - hair nicotine

  Child exposure to tobacco smoke as assessed by hair nicotine level

  Baseline, 6 months post-intervention

Secondary Outcomes (4)

• Child exposure to tobacco smoke - parental report

  Baseline, 6 months post-intervention

• Child health status

  Baseline, 6 months post-intervention (continuous)

• Respirable Small Particle (RSPs - PM2.5) level in home

  Baseline, 1 month post-intervention

• Air nicotine

  Baseline, 6 months post-intervention

Study Arms (1)

Intervention

EXPERIMENTAL

Participants received the behavioral intervention, which was designed to motivate parents to protect their children from tobacco smoke exposure

Behavioral: Intervention

Interventions

Intervention BEHAVIORAL

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.

Intervention

Eligibility Criteria

• Age: Up to 8 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• One of above conditions not met

Sponsors & Collaborators

• Tel Aviv University: lead

Study Sites (1)

Tel Aviv University

Ramat Aviv, Israel, 69978, Israel

Location

Related Publications (7)

• 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.

  PMID: 21711530 BACKGROUND

• 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.

  PMID: 22201152 RESULT

• 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.

  PMID: 24664094 RESULT

• 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.

  PMID: 26160037 RESULT

• 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.

  PMID: 26633440 RESULT

• 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.

  PMID: 29292311 DERIVED

• 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.

  PMID: 29059387 DERIVED

MeSH Terms

Interventions

Methods

Intervention Hierarchy (Ancestors)

Investigative Techniques

Study Officials

• Laura J Rosen, PhD

  Tel Aviv University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chair, Dept. of Health Promotion, School of Public Health, Sackler Faculty of Medicine

Study Record Dates

• First Submitted: April 12, 2011
• First Posted: April 14, 2011
• Study Start: January 1, 2013
• Primary Completion: September 1, 2015
• Study Completion: September 1, 2015
• Last Updated: December 9, 2015

Record last verified: 2015-11

Locations

IL (1)