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

Not Applicable

Recruiting

• Conditions: Secondhand Smoke Exposure

• Registration Number: NCT07003282
• Lead Sponsor: Hebrew University of Jerusalem

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2025-03-30
• Status Verified: 2025-05
• Study First Submitted: 2025-05-18
• Study First Submitted QC: 2025-05-25
• Last Update Submitted: 2025-05-25
• Study First Posted: 2025-06-04
• Last Update Posted: 2025-06-04
• Primary Completion: 2025-07-01
• Study Completion: 2025-10-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 160

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Recruitment rate	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 Outcome Measures

Name	Time	Method
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.	Number of minutes spent by each participant on the digital intervention platform
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.	Number of participants that completed all questionnaires at baseline, 4 weeks (only for women) and 12 weeks
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.	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.
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.	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.
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.	Number of women who completed a urinary cotinine test at baseline.
Self-report of perceived SHS exposure	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.
Self-report of a complete smoke free home	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).
Self-report of changes in smoke-free home rules	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.
Objective SHS exposure (only for women)	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.
Self-report of smoking cessation (only for men)	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.
Self-report of changes in smoking habits (only for men)	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.
Nicotine-replacement therapy use at home (only for men)	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.
Performance of at least one follow-up cotinine test (only for women)	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

Trial Locations

Locations (1)

Braun School of Public Health and Community Medicine, Hebrew University of Jerusalem; 🇮🇱 Jerusalem, Israel