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

Hebrew University of Jerusalem

Status: Enrolling

Conditions: Secondhand Smoke Exposure

Treatments: Behavioral: 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)

Study type: Interventional

Funder types: Other

Identifiers

NCT07003282

09032025

Details and patient eligibility

About

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.

Enrollment: 160 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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160 participants in 2 patient groups

Intervention arm: testing the "First Breath" digital intervention

Experimental group

Description:

Expectant fathers receive an acess to the digital intervention "First Breath" and are asked to complete a questionnaire at baseline and after 3 months. Pregnant women receive an access to the digital intervention and are also asked to provide an urine sample (for measurement of urine cotinine concentration) and to complete a questionnaire during study visits (at Hadassah Ein Karem) at baseline, after 1 and 3 months.

Treatment:

Behavioral: 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)

Control group

No Intervention group

Description:

Instead of the "First Breath" intervention, participants (both men and women) receive a link to a website that contains uploaded standard educational material from the Israel Cancer Association website. Participants will be asked to complete a questionnaire at baseline and after 1 months (only women) and 3 months follow-up, and women are asked to provide urine samples (for measurement of cotinine concentration) at baseline, after 1 and 3 months.