First Breath: a digital program to reduce prenatal secondhand smoke exposure

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This pilot enrolls pregnant women up to 24 weeks who do not smoke and their smoking partners to test a digital behavioral program called First Breath. Participants use the app, receive follow-up reminders, and pregnant women receive personal urine cotinine results as biochemical feedback. The program combines education on health risks, stepwise strategies to avoid exposure in the home and car, motivation-building, and advice about using nicotine-replacement therapy in the household. Feasibility and acceptability outcomes will be collected during follow-up to refine the intervention for larger trials.

Why it matters

Who can join: the full rules

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.

Where it's running

• Braun School of Public Health and Community Medicine, Hebrew University of Jerusalem
  Jerusalem, Israel Recruiting

Study contacts

• Principal investigator: Yael Bar-Zeev, MD MPH PhD — Hebrew University of Jerusalem
• Study coordinator: Yael Bar Zeev, MD MPH PhD
• Email: Yael.Bar-Zeev@mail.huji.ac.il
• Phone: +972-58-6878941

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.