An interventional study of 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) in Secondhand Smoke Exposure, sponsored by Hebrew University of Jerusalem. Recruiting at 1 site in Israel. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-09-12.
Sponsored by Hebrew University of Jerusalem · Not applicable, Interventional, and Prevention
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.
Hebrew University of Jerusalem is the lead sponsor of 31 studies on the registry; 4 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Pregnant women:
Inclusion criteria:
e) currently not smoking any tobacco or nicotine product (to clarify, women who smoked in the past are eligible).
Exclusion criteria:
Expectant fathers who smoke:
Inclusion criteria:
Exclusion criteria:
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)
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.
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).
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.
Time frame: From day of recruitment of the first participant to day of recruitement of the last participant, assessed up to 3 months
Overall compliance
Number of participants that completed all questionnaires at baseline, 4 weeks (only for women) and 12 weeks
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.
Intervention completion rate
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.
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.
Intervention re-enter rate
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.
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.
Intervention compliance
Number of minutes spent by each participant on the digital intervention platform
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.
Performance of a cotinine baseline test (only for women)
Number of women who completed a urinary cotinine test at baseline.
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.
Performance of at least one follow-up cotinine test (only for women)
Number of women who completed urinary cotinine test at 4 weeks and/or 12 weeks
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.
Self-report of perceived SHS exposure
Changes in self-reported SHS exposure level from baseline to 4 weeks (only for women) and 12 weeks.
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.
Self-report of a complete smoke free home
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).
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.
Self-report of changes in smoke-free home rules
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.
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.
Objective SHS exposure (only for women)
Changes in secondhand smoke exposure by urine cotinine levels from baseline to 4 and 12 weeks.
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.
Self-report of smoking cessation (only for men)
Proportion of participants that reported to have quit smoking at three months follow up.
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.
Self-report of changes in smoking habits (only for men)
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.
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.
Nicotine-replacement therapy use at home (only for men)
Proportion of participants that reported using nicotine replacement therapy at home at three months follow up.
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.
Plan to share: Yes — Individual participant data that underlie the results after deidentification
Supporting information: Study protocol, Informed consent form
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
Started Mar 2025 (actual). Primary completion is estimated for Oct 2025, 7 months after the start.
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Hebrew University of Jerusalem