Clinical trial NCT07003282: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Secondhand Smoke Exposure
Keywords: Prenatal secondhand smoke exposure
Digital behavioral intervention
Lead sponsor: Hebrew University of Jerusalem
Sponsor class: OTHER
First posted: 2025-06-04
Enrollment: 160
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility criteria: Pregnant women:

Inclusion criteria:

1. ≤24 gestational weeks;
2. at least 18 years old;
3. 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:

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

Expectant fathers who smoke:

Inclusion criteria:

1. male,
2. at least 18 years old,
3. able to understand Hebrew at a reasonable level,
4. smoking at least one combustible cigarette per day,
5. currently living with a pregnant spouse who does not smoke any tobacco or nicotine product and
6. 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:

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

Primary outcomes:
measure: Recruitment rate
timeFrame: From day of recruitment of the first participant to day of recruitement of the last participant, assessed up to 3 months
Secondary outcomes:
measure: Overall compliance
timeFrame: 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.
measure: Intervention completion rate
timeFrame: 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.
measure: Intervention re-enter rate
timeFrame: 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.
measure: Intervention compliance
timeFrame: 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.
measure: Performance of a cotinine baseline test (only for women)
timeFrame: 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.
measure: Performance of at least one follow-up cotinine test (only for women)
timeFrame: 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.
measure: Self-report of perceived SHS exposure
timeFrame: 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.
measure: Self-report of a complete smoke free home
timeFrame: 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.
measure: Self-report of changes in smoke-free home rules
timeFrame: 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.
measure: Objective SHS exposure (only for women)
timeFrame: 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.
measure: Self-report of smoking cessation (only for men)
timeFrame: 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.
measure: Self-report of changes in smoking habits (only for men)
timeFrame: 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.
measure: Nicotine-replacement therapy use at home (only for men)
timeFrame: 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.
Other outcomes:
Locations:
city: Jerusalem
country: Israel
facility: Braun School of Public Health and Community Medicine, Hebrew University of Jerusalem
Study officials:
affiliation: Hebrew University of Jerusalem
name: Yael Bar-Zeev, MD MPH PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.