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

Feasibility and Acceptability of a Digital Intervention Program Aiming to Reduce Secondhand Smoke Exposure in Pregnancy: a Pilot Study

This pilot tests the First Breath app with pregnant women and their smoking partners to help reduce secondhand smoke exposure at home and in the car.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 160 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Hebrew University of Jerusalem (Academic / other)
• Locations: 1 site (Jerusalem)
• Trial ID: NCT07003282 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates are pregnant, non-smoking women ≤24 weeks gestation who live with an adult partner who smokes daily and both can read Hebrew and access the internet.

Not a fit: Women with high-risk pregnancies, those without internet access, or couples whose smoking partner is already enrolled in a cessation program are unlikely to receive benefit from this intervention.

Why it matters

Potential benefit: If successful, it could lower pregnant women's exposure to secondhand smoke and reduce related risks to fetal and maternal health.

How similar studies have performed: Similar partner-inclusive digital interventions and biomarker feedback approaches have shown promising results in reducing household secondhand smoke, but evidence specifically in prenatal populations remains limited.

Eligibility criteria

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 this trial is running

Jerusalem

• 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

Conditions Secondhand Smoke Exposure; Prenatal secondhand smoke exposure; Digital behavioral intervention