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A Study to Test Feasibility and Acceptability of an Intervention Program Aiming to Reduce Prenatal Secondhand Smoke Exposure

RecruitingNAAges 18 Years - anyAllHebrew University of Jerusalem
NCT07003282 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

This pilot study assess the feasibility and acceptability of the "First Breath" digital behavioral intervention aiming to reduce prenatal SHS exposure. By involving both the pregnant women and partners (who smoke) of pregnant women, our intervention encourages reducing secondhand smoke exposure at home and in the car, through a gradual, capacity and self-efficacy building, structured plan. "First Breath" focus on raising knowledge about the health consequences of prenatal secondhand exposure, proposing strategies to avoid exposure, and raising motivation to implement a smoke free home and car. Our intervention also includes personal biochemical feedback to the pregnant women using urine cotinine (a marker of secondhand smoke exposure), and advice on using nicotine-replacemnt therapy within the home setting to avoid smoking.

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📋 Eligibility rules (as published)
Pregnant women: Inclusion criteria: 1. ≤24 gestational weeks; 2. at least 18 years old; 3. living with a partner who smokes (at least one combustible cigarette a day); d) ability to understand Hebrew at a reasonable level; e) currently not smoking any tobacco or nicotine product (to clarify, women who smoked in the past are eligible). Exclusion criteria: 1. women with high-risk pregnancies, 2. no access to internet, 3. her partner is currently involved in a smoking cessation process. Expectant fathers who smoke: Inclusion criteria: 1. male, 2. at least 18 years old, 3. able to understand Hebrew at a reasonable level, 4. smoking at least one combustible cigarette per day, 5. currently living with a pregnant spouse who does not smoke any tobacco or nicotine product and 6. the spouse is ≤24 gestational weeks . Note: expectant father who are current users of other tobacco products (such as electronic cigarettes) are also eligible as long as they smoke at least one combustible cigarette a day. Exclusion criteria: 1. currently engaged in a smoking cessation program, 2. no access to the internet.
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What it tests

  • The intervention includes 1) the "First Breath" app, 2) reminders during the follow-up period and 3) only for women- cotinine concentration measurement (a biomarker of secondhand smoke exposure)
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Where

1 site
Braun School of Public Health and Community Medicine, Hebrew University of Jerusalem
Jerusalem, Israel
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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