Clinical trial NCT02867241: An Intervention to Protect Young Children From Tobacco Smoke Exposure
Official title: An Intervention to Protect Young Children From Tobacco Smoke Exposure
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Passive Smoking
Lead sponsor: Tel Aviv University
Sponsor class: OTHER
Collaborators: name: Flight Attendant Medical Research Institute (FAMRI)
name: Hebrew University
name: Assaf-Harofeh Medical Center
name: Tel Aviv University
First posted: 2016-08-15
Enrollment: 160
Sex: ALL
Maximum age (years): 8
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The primary goal of this research is to evaluate the effectiveness of an intervention for parents to reduce tobacco smoke exposure of young children

Detailed description: The primary aim of this intervention is to reduce exposure of children to tobacco smoke, through an intervention program designed to help parents better perceive exposure and its harms, and to provide tools for assisting them in protecting children. Secondary aims are to understand the relationships between parentally-reported and objectively measured child tobacco smoke exposure, to assess the relationship between tobacco smoke exposure and health and health care utilization, and to better understand parental perceptions of tobacco smoke exposure (PPE) and parental perceptions of risk (PPR) from tobacco smoke exposure. The effectiveness of the intervention will be evaluated using a randomized controlled trial.

This RCT is a continuation of previous work. Originally the entire research project, which included a Pilot Study and a Randomized Controlled Trial (RCT) was registered as NCT01335178. Upon completion of the Pilot Study, we closed NCT01335178 and opened a new one for the RCT with the current registration number.

Eligibility criteria: Inclusion Criteria for RCT :

1. - Families in which at least one parent smokes, and both parents combined smoke a minimum of 10 cigarettes per week
2. - Parents willing to provide child hair samples
3. - Hebrew speaking participants
4. - Parents are willing to participate from time of entry for the coming 8 months .

Exclusion Criteria:

There are no additional exclusion criteria

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Primary outcomes:
measure: Change in child exposure to tobacco smoke as assessed by log hair nicotine
timeFrame: Baseline and 6 months post-enrollment
Secondary outcomes:
measure: Change in child exposure to tobacco smoke as assessed by parental report
timeFrame: Baseline and 6 months post-enrollment
measure: Change in smoking practices in the home as reported by parents
timeFrame: Baseline and 6 months post-enrollment
measure: Change in parental smoking
timeFrame: Baseline and 6 months post-enrollment
measure: Change in parental perceptions of risk due to smoking, intervention and expanded control groups
timeFrame: Baseline and 6 months post-enrollment
measure: Change in parental perceptions of tobacco smoke exposure, intervention and expanded control groups
timeFrame: Baseline and 6 months post-enrollment
measure: Child health
timeFrame: 6 months post-enrollment
measure: Child health services utilization
timeFrame: 6 months post-enrollment
measure: Change in smoking practices in the car as reported by parents
timeFrame: Baseline and 6 months post-enrollment
measure: Change in parentally-reported number of cigarettes smoked
timeFrame: Baseline and 6 months post-enrollment
measure: Change in parentally-reported child exposure to tobacco smoke, intervention and expanded control groups
timeFrame: Baseline and 6 months post-enrollment
measure: Parental perceptions of risk due to smoking, intervention versus control group
timeFrame: 6 months post-enrollment
measure: Parental perceptions of tobacco smoke exposure, intervention versus control group
timeFrame: 6 months post-enrollement
measure: Correlations between parentally-reported exposure and child log hair nicotine
timeFrame: baseline
measure: Correlations between parentally-reported exposure and child log hair nicotine
timeFrame: 6 months
Other outcomes:
Locations:
city: Ramat Aviv
country: Israel
facility: Tel Aviv University
Study officials:
affiliation: Tel Aviv University
name: Laura J Rosen, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hebrew University
name: David M Zucker, PhD
role: STUDY_DIRECTOR
References:
citation: Rosen L, Zucker D, Guttman N, Brown N, Bitan M, Rule A, Berkovitch M, Myers V. Protecting Children From Tobacco Smoke Exposure: A Randomized Controlled Trial of Project Zero Exposure. Nicotine Tob Res. 2021 Nov 5;23(12):2003-2012. doi: 10.1093/ntr/ntab106.
citation: Myers V, Shiloh S, Zucker DM, Rosen LJ. Changing Exposure Perceptions: A Randomized Controlled Trial of an Intervention with Smoking Parents. Int J Environ Res Public Health. 2020 May 12;17(10):3349. doi: 10.3390/ijerph17103349.