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

NCT07003282 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 160

Last updated 2025-09-12

No results posted yet for this study

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.

Conditions

  • Secondhand Smoke Exposure

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, 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).

Sponsors & Collaborators

  • Hebrew University of Jerusalem

    lead OTHER

Principal Investigators

  • Yael Bar-Zeev, MD MPH PhD · Hebrew University of Jerusalem

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-03-30
Primary Completion
2025-10-30
Completion
2025-12-01

Countries

  • Israel

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07003282 on ClinicalTrials.gov