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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT02867241
Other study ID # 0143-16ASF
Secondary ID
Status Active, not recruiting
Phase Phase 3
First received
Last updated
Start date August 2016
Est. completion date December 2018

Study information

Verified date August 2018
Source Tel Aviv University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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


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.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 160
Est. completion date December 2018
Est. primary completion date July 2018
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group N/A to 8 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Behavioral Early
Participants will receive an intervention which includes motivational interviewing, biochemical feedback, air quality feedback, phone calls, and social media
Behavioral Late
After the close of the study, Participants will receive an intervention which includes motivational interviewing, biochemical feedback, air quality feedback, phone calls, and social media

Locations

Country Name City State
Israel Tel Aviv University Ramat Aviv

Sponsors (5)

Lead Sponsor Collaborator
Laura J. Rosen Asaf HaRofeh Hospital, Flight Attendant Medical Research Institute (FAMRI), Hebrew University, Tel Aviv University

Country where clinical trial is conducted

Israel, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change in child exposure to tobacco smoke as assessed by log hair nicotine A small amount of hair will be taken from the child's head near the scalp and sent to a laboratory for analysis Baseline and 6 months post-enrollment
Secondary Change in child exposure to tobacco smoke as assessed by parental report Frequency of child exposure to tobacco smoke as measured by a single question Baseline and 6 months post-enrollment
Secondary Change in smoking practices in the home as reported by parents Smoking practices in the home as measured by a single question Baseline and 6 months post-enrollment
Secondary Change in parental smoking Parental quit rates Baseline and 6 months post-enrollment
Secondary Change in parental perceptions of risk due to smoking, intervention and expanded control groups Measurement of risk resulting in a single composite number using a validated questionnaire Baseline and 6 months post-enrollment
Secondary Change in parental perceptions of tobacco smoke exposure, intervention and expanded control groups Measurement of exposure perceptions resulting in a single composite number using a validated questionnaire Baseline and 6 months post-enrollment
Secondary Child health Number of child illnesses related to tobacco smoke exposure 6 months post-enrollment
Secondary Child health services utilization Number of visits to physicians or emergency care services 6 months post-enrollment
Secondary Change in smoking practices in the car as reported by parents Frequency of smoking in the car (single question) Baseline and 6 months post-enrollment
Secondary Change in parentally-reported number of cigarettes smoked Reported number of cigarettes smoked by parents daily Baseline and 6 months post-enrollment
Secondary Change in parentally-reported child exposure to tobacco smoke, intervention and expanded control groups Detailed parental report on when and how often child is exposed to tobacco smoke, as summarized by composite scale Baseline and 6 months post-enrollment
Secondary Parental perceptions of risk due to smoking, intervention versus control group Measurement of risk perceptions resulting in a single composite number using a validated questionnaire 6 months post-enrollment
Secondary Parental perceptions of tobacco smoke exposure, intervention versus control group Measurement of exposure perceptions resulting in a single composite number using a validated questionnaire 6 months post-enrollement
Secondary Correlations between parentally-reported exposure and child log hair nicotine Pearson correlations baseline
Secondary Correlations between parentally-reported exposure and child log hair nicotine Pearson correlations 6 months
See also
  Status Clinical Trial Phase
Completed NCT04292548 - Salivary TAS, TOS, LL-37 and Dental Status in Passive Smoking Children
Completed NCT04298996 - Effect of Passive Smoking on Oxidative Stress and Dental Caries in Children
Not yet recruiting NCT00647413 - Prevent Exposure to Tobacco Smoke at Home [Gesunde Atemluft zu Hause] N/A
Not yet recruiting NCT05996029 - A Joint Real-World Study of Digital Smoking Cessation Interventions N/A