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NCT Number: NCT07003282

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

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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Key information

Conditions

Secondhand Smoke Exposure

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Jerusalem, Israel

Location status: Recruiting

Location contact

Yael Bar Zeev, MD MPH PhD

CONTACT

[email protected]

+972-58-6878941

Yael Bar-Zeev, MD MPH PhD

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Pregnant women:

Inclusion criteria

  • ≤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).

Exclusion criteria

  • women with high-risk pregnancies,
  • no access to internet,
  • her partner is currently involved in a smoking cessation process.

Expectant fathers who smoke:

Inclusion criteria

  • 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.

Exclusion criteria

  • currently engaged in a smoking cessation program,
  • no access to the internet.

Treatment and study plan

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).

Primary outcomes

  1. Recruitment rate

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

    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.

Secondary outcomes

  1. Overall compliance

    Time frame: 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.

    Number of participants that completed all questionnaires at baseline, 4 weeks (only for women) and 12 weeks

  2. Intervention completion rate

    Time frame: 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.

    Number of participants who completed at least one full cycle of the digital intervention components (including the "exposure score" and action plan), divided by the number of participants that had signed an informed consent to participate.

  3. Intervention re-enter rate

    Time frame: 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.

    Number of participants who re-entered the digital intervention within 1,2 and 3 months, divided by the number of participants that had signed an informed consent to participate.

  4. Intervention compliance

    Time frame: 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.

    Number of minutes spent by each participant on the digital intervention platform

  5. Performance of a cotinine baseline test (only for women)

    Time frame: 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.

    Number of women who completed a urinary cotinine test at baseline.

  6. Performance of at least one follow-up cotinine test (only for women)

    Time frame: From date of the first follow-up meeting of the first participant (woman) until the date of the second follow-up meeting to the last participant (woman) of the study, assessed up to 5 months.

    Number of women who completed urinary cotinine test at 4 weeks and/or 12 weeks

  7. Self-report of perceived SHS exposure

    Time frame: 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.

    Changes in self-reported SHS exposure level from baseline to 4 weeks (only for women) and 12 weeks.

  8. Self-report of a complete smoke free home

    Time frame: From date of the last follow-up meeting of the first participant until the date of the last follow-up meeting to the last participant of the study, assessed up 3 months.

    Proportion of participants reported that smoking is not allowed at all at home (and near the home, such as in the balcony or staircase) post-intervention (12 weeks after starting the intervention).

  9. Self-report of changes in smoke-free home rules

    Time frame: From date of the second follow-up meeting of the first participant until the date of the last follow-up meeting to the last participant of the study, assessed up 3 months.

    Proportion of participants reported that they (or their partner) made any change in home smoking rules (even if they do not have a complete SFH) 12 weeks after starting the intervention.

  10. Objective SHS exposure (only for women)

    Time frame: From date of the first signed inform consent form (woman) until the date of the third follow-up meeting of the last participant (woman) of the study, assessed up to 6 months.

    Changes in secondhand smoke exposure by urine cotinine levels from baseline to 4 and 12 weeks.

  11. Self-report of smoking cessation (only for men)

    Time frame: From date of the second follow-up meeting of the first participant (man) until the date of the second follow-up meeting to the last participant (man) of the study, assessed up 3 months.

    Proportion of participants that reported to have quit smoking at three months follow up.

  12. Self-report of changes in smoking habits (only for men)

    Time frame: From date of the first signed inform consent form (man) until the date of the second follow-up meeting of the last participant (man) of the study, assessed up to 6 months.

    The difference in the average number of cigarettes smoked per day on a typical day, at home, between the baseline and three months follow up.

  13. Nicotine-replacement therapy use at home (only for men)

    Time frame: From date of the second follow-up meeting of the first participant (man) until the date of the second follow-up meeting to the last participant (man) of the study, assessed up 3 months.

    Proportion of participants that reported using nicotine replacement therapy at home at three months follow up.

Study contacts

Contact information is provided by the study sponsor or research team.

Anne-Laure Yehudit Guri-Scherman, MsC MPH

CONTACT

[email protected]

+972-52-6698-454

Yael Bar Zeev, MD MPH PhD

CONTACT

[email protected]

+972-58-6878941

Sponsors and collaborators

Lead sponsor

Hebrew University of Jerusalem

Other

Registry information

Official study title

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

Acronym: First Breath

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Jun 4, 2025
Registry last updated
Sep 12, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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