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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorHebrew University of Jerusalem

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

≤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;

Disqualifiers

women with high-risk pregnancies,

no access to internet,

her partner is currently involved in a smoking cessation process.

male,

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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)

    Behavioral

    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).

Treatment groups

160 Participants
are divided into 2 treatment groups
Group A: Intervention arm: testing the "First Breath" digital interventionExperimental treatment 1 intervention
Group B: Control groupNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

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.

Time frame
From day of recruitment of the first participant to day of recruitement of the last participant, assessed up to 3 months

Secondary outcomes

1

Overall compliance

Number of participants that completed all questionnaires at baseline, 4 weeks (only for women) and 12 weeks

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.
2

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.

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.
3

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.

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.
4

Intervention compliance

Number of minutes spent by each participant on the digital intervention platform

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.

Other outcomes

Sponsors and contacts

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