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

NCT07003282 | Recruiting

• 1 other identifier: 09032025
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Secondhand Smoke Exposure

Keywords

Prenatal secondhand smoke exposure; Digital behavioral intervention

Outcome Measures

Primary Outcomes (1)

• Recruitment rate

  Number of participants that sign the informed consent, divided by the total number of participants who were approached for recruitment. Recruitment rate will be calculated separately for pregnant women and expectant fathers' participants.

  From day of recruitment of the first participant to day of recruitement of the last participant, assessed up to 3 months

Secondary Outcomes (13)

• Overall compliance

  From day of recruitment of the first participant to day of the last follow-up meeting of the last participant, assessed up to 6 months.

• Intervention completion rate

  From day of recruitment of the first participant to day of the last follow-up meeting of the last participant, assessed up to 6 months.

• Intervention re-enter rate

  From date of the first signed inform consent form until the date of the last follow-up meeting of the last participant, assessed up to 6 months.

• Intervention compliance

  From day of recruitment of the first participant to day of the last follow-up meeting of the last participant, assessed up to 6 months.

• Performance of a cotinine baseline test (only for women)

  From date of the first signed informed consent form (woman) until date of the last signed informed consent form (women), assessed up to 3 months.

Study Arms (2)

Intervention arm: testing the "First Breath" digital intervention

EXPERIMENTAL

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.

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

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.

Interventions

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) BEHAVIORAL

The intervention focus on raising knowledge about the health consequences of prenatal secondhand smoke exposure, proposing strategies to avoid exposure at home and in the car, and raising motivation to implement a smoke-free home and car. An "exposure score" of each participant is calculated, based on his perception of secondhand smoke exposure, smoking rules within the home and strategies used to reduce exposure. Participants are guided in setting specific goals, with a detailed action plan, and receive ongoing feedback throughout follow up. In addition, for pregnant women, urine cotinine measurements at baseline, 4-weeks and 12-weeks study visit are integrated into the intervention and personalized biofeedback provided to them . Participants of the intervention arm also receive remiders (by WhatsApp) to re-use the App during all the follow-up period (3 times during the first week, 2 times/week during the 2nd, 3th and 4th weeks, and then once a week until the end of follow-up).

Intervention arm: testing the "First Breath" digital intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ≤24 gestational weeks;
• at least 18 years old;
• 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).

You may not qualify if:

• women with high-risk pregnancies,
• no access to internet,
• her partner is currently involved in a smoking cessation process.
• Expectant fathers who smoke:
• male,
• at least 18 years old,
• able to understand Hebrew at a reasonable level,
• smoking at least one combustible cigarette per day,
• currently living with a pregnant spouse who does not smoke any tobacco or nicotine product and
• 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.
• currently engaged in a smoking cessation program,
• no access to the internet.

Sponsors & Collaborators

• Hebrew University of Jerusalem: lead

Study Sites (1)

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

Jerusalem, Israel

RECRUITING

Related Publications (2)

• Rodnay M, Agbaria N, Neumark Y, Guri-Scherman AY, Bar Zeev Y. "What can I do? fight him?" Perceptions and Experiences in Reducing Secondhand Smoke Exposure During Pregnancy: A Qualitative Study Among Israeli Women. Nicotine Tob Res. 2025 May 22;27(6):962-969. doi: 10.1093/ntr/ntae291.

  PMID: 39673392 BACKGROUND

• Guri-Scherman AY, Neumark Y, Rodnay M, Bar-Zeev Y. Barriers and Enablers to Implementing a Smoke-free Home and Car During Pregnancy: A Qualitative Study Among Expectant Israeli Fathers. Nicotine Tob Res. 2024 Jan 1;26(1):94-101. doi: 10.1093/ntr/ntad149.

  PMID: 37565607 BACKGROUND

MeSH Terms

Interventions

Single Person

Intervention Hierarchy (Ancestors)

Marital Status; Family Characteristics; Demography; Population Characteristics; Socioeconomic Factors

Study Officials

• Yael Bar-Zeev, MD MPH PhD

  Hebrew University of Jerusalem

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yael Bar Zeev, MD MPH PhD

CONTACT

+972-58-6878941; Yael.Bar-Zeev@mail.huji.ac.il

Anne-Laure Yehudit Guri-Scherman, MsC MPH

CONTACT

+972-52-6698-454; anne-laure.scherman@mail.huji.ac.il

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: May 18, 2025
• First Posted: June 4, 2025
• Study Start: March 30, 2025
• Primary Completion: October 30, 2025
• Study Completion: December 1, 2025
• Last Updated: September 12, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: Immediately following publication, no end date
• Access Criteria: Researchers who provide a methodologically sound proposal, proposals should be directed to Yael.Bar-Zeev@mail.huji.ac.il. To gain access, researchers will need to sign a data access agreement

Locations

IL (1)