Secondhand Smoke ExposureFirst BreathNCT07003282
A Study to Test Feasibility and Acceptability of an Intervention Program Aiming to Reduce Prenatal Secondhand Smoke Exposure
A study testing 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 people with Secondhand Smoke Exposure, run by Hebrew University of Jerusalem at 1 site in Israel.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Secondhand Smoke Exposure
- What is being tested?
- 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)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- 1 siteIsrael
- Study dates
- 30 Mar 2025to 1 Dec 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ≤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;
- currently not smoking any tobacco or nicotine product (to clarify, women who smoked in the past are eligible).
- male,
- at least 18 years old,
Show all 10Show fewer
- 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.
Who cannot join
- women with high-risk pregnancies,
- no access to internet,
- her partner is currently involved in a smoking cessation process.
- Expectant fathers who smoke:
- currently engaged in a smoking cessation program,
- no access to the internet.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Anne-Laure Yehudit Guri-Scherman, MsC MPH contact
Israel1 site, 1 recruiting
- Recruiting
Braun School of Public Health and Community Medicine, Hebrew University of Jerusalem
Jerusalem
Yael Bar Zeev, MD MPH PhD, +972-58-6878941, Yael.Bar-Zeev@mail.huji.ac.il
Yael Bar-Zeev, MD MPH PhD
About this study
Official title: Feasibility and Acceptability of a Digital Intervention Program Aiming to Reduce Secondhand Smoke Exposure in Pregnancy: a Pilot Study
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.
- Conditions
- Secondhand Smoke Exposure
- Being tested
- 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)
- Keywords
- Prenatal secondhand smoke exposure, Digital behavioral intervention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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)Behavioural
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).
| Study group | Role | What they receive |
|---|---|---|
| Intervention arm: testing the "First Breath" digital intervention | Experimental | 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. Receives: 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) |
| Control group | No intervention | 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From day of recruitment of the first participant to day of recruitement of the last participant, assessed up to 3 months
Secondary outcomes (13)
Overall compliance
Number of participants that completed all questionnaires at baseline, 4 weeks (only for women) and 12 weeks
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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.
Measured: 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
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2025
- Study start30 Mar 2025
- Primary completion30 Oct 2025 (estimated)
- Study completion1 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Secondhand Smoke ExposureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hebrew University of Jerusalem
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Professor Yael Bar Zeev, Hebrew University of Jerusalem
- Investigators
- Yael Bar-Zeev, MD MPH PhD, Principal investigator, Hebrew University of Jerusalem
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07003282
- Sponsor's protocol ID
- 09032025
- Acronym
- First Breath
- Status last verified
- May 2025
- First submitted
- 18 May 2025
- Last updated
- 12 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data that underlie the results after deidentification
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.
PubMed 39673392Guri-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.
PubMed 37565607
Study at a glance
From the registry record, last updated by the sponsor on 12 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility and Acceptability of a Digital Intervention Program Aiming to Reduce Secondhand Smoke Exposure in Pregnancy: a Pilot Study
- ClinicalTrials.gov ID
- NCT07003282
- Acronym / sponsor ID
- First Breath / 09032025
- Conditions
- Secondhand Smoke Exposure
- Keywords
- Prenatal secondhand smoke exposure, Digital behavioral intervention
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- Hebrew University of JerusalemUniversity, hospital or other
- Study start
- 30 Mar 2025 (actual)
- Primary completion
- 30 Oct 2025 (estimated)
- Study completion
- 1 Dec 2025 (estimated)
- First posted
- 4 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention arm: testing the "First Breath" digital intervention | Experimental | 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)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. |
| Control group | No intervention | –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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- ≤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;
- currently not smoking any tobacco or nicotine product (to clarify, women who smoked in the past are eligible).
- male,
Key exclusion criteria (6 listed)
- women with high-risk pregnancies,
- no access to internet,
- her partner is currently involved in a smoking cessation process.
- currently engaged in a smoking cessation program,
- no access to the internet.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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, 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). | Behavioural | Intervention arm: testing the "First Breath" digital intervention |
Primary outcome
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.
13 secondary outcomes
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.
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Sep 2025.
- Background: PubMed 39673392Rodnay 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.
- Background: PubMed 37565607Guri-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.
- Individual participant dataSharing planned: Yes. Individual participant data that underlie the results after deidentification
Related trials for Secondhand Smoke Exposure
Not yet recruitingObservational study
Postoperative Residual Neuromuscular Block and Passive Smoke Exposure in Pediatric Dental Patients
Postoperative Residual Curarization, Neuromuscular Block Prolonged
RecruitingPhase 4
Secondhand Tobacco Smoke and Cardiovascular Disease
Cardiovascular Diseases, Hypertension
RecruitingPhase 4
Modifying Progesterone and Estradiol Levels to Prevent Postpartum Cigarette Smoking Relapse and Reduce Secondhand Smoke Exposure in Infants and Children
Smoking, Smoking Cessation
Recruiting
Implementing an Adapted Smoke-free Homes Intervention in Spain
Secondhand Tobacco Smoke Exposure Reduction, Smoking Prevention
Recruiting
Measuring Environmental Tobacco and Cannabis: Pollutants and Exposures
Healthy
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Anne-Laure Yehudit Guri-Scherman, MsC MPH contact
Yael Bar-Zeev, MD MPH PhD principal investigator
Hebrew University of Jerusalem
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 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 people with Secondhand Smoke Exposure, run by Hebrew University of Jerusalem at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 12 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yael Bar Zeev, MD MPH PhD (+972-58-6878941, Yael.Bar-Zeev@mail.huji.ac.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07003282, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Sep 2025.