Feasibility and Acceptability of a Digital Intervention Program Aiming to Reduce Secondhand Smoke Exposure in Pregnancy: a Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 160
- 试验地点
- 1
- 主要终点
- Recruitment rate
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Pregnant women:
- •Inclusion criteria:
- •≤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;
- •e) currently not smoking any tobacco or nicotine product (to clarify, women who smoked in the past are eligible).
排除标准
- •women with high-risk pregnancies,
- •no access to internet,
- •her partner is currently involved in a smoking cessation process.
- •Expectant fathers who smoke:
- •Inclusion criteria:
- •at least 18 years old,
- •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.
- •Exclusion criteria:
- •currently engaged in a smoking cessation program,
- •no access to the internet.
研究组 & 干预措施
Intervention arm: testing the "First Breath" digital intervention
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.
干预措施: 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)
Control group
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.
结局指标
主要结局
Recruitment rate
时间窗: 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.
次要结局
- 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.)
- 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.)
- 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.)
- 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.)
- 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.)
- 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.)
- 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.)
- 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.)
- 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.)
- 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.)
- 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.)
- 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.)
- 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.)
研究者
Professor Yael Bar Zeev
Associate Professor
Hebrew University of Jerusalem