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

Official title

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

Overview

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.

Interventions

• 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)
  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, an

Primary outcome measures

• 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]

Secondary outcome measures (12)

• 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.]
• 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.]
• 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.]
• 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.]
• 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.]
• 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.]
• 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.]
• 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.]
• 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.]
• 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.]
• 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.]
• 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.]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Single blind

Primary purpose

Prevention

Study locations

Israel · 1 center

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

Publications

• 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
• 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

Identifiers

NCT: NCT07003282 · 09032025

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗