Evaluation of Pregnant Women's Smoking Cessation Outcomes Using the Application

JRCT ID: jRCT1050230183

Registered date:16/02/2024

Basic Information

• Recruitment status: Pending
• Health condition(s) or Problem(s) studied: Smoking in pregnant women
• Date of first enrollment: 20/01/2024
• Target sample size: 56
• Study type: Interventional

Intervention(s)

The study is aimed at pregnant women with a gestational age of 20 weeks or less, with the intervention group receiving smoking cessation support through cognitive-behavioral therapy in the Pregnant Women Smoking Cessation App continuously from the gestational age to one year postpartum.
The content of the Pregnant women's smoking cessation app is based on the Standard Procedures for Smoking Cessation Support of the Ministry of Health, Labor and Welfare, with the addition of pregnant women's characteristics.
Individual consultations in the app are used according to needs, with no set number of sessions.
The control group receives existing smoking cessation support.
Both intervention and control groups will be surveyed at the time of obtaining research consent, at 35 weeks' gestation, one month postpartum and one year postpartum for smoking volume and behavior change stage.

Outcome(s)

• Primary Outcome: carbon monoxide breathalyzer concentration

Secondary Outcome

Evaluation of the association between smoking cessation outcomes and health literacy, self-efficacy, and health concern.
Evaluation of the association between smoking cessation outcomes and parenting burden and depression will be assessed in the long-term evaluation.

Key inclusion & exclusion criteria

• Age minimum: >= 16age old
• Age maximum: Not applicable
• Gender: Female

Include criteria

1. Pregnant women who are 16 years of age or older at the time consent is obtained.
2. Pregnant women who are in the "indifference," "interest," "preparation," and "implementation" stages of the Smoking Cessation Behavior Change Stage Model at the time consent is obtained.
3. Pregnant women who have fully understood the explanation provided on the web screen and have given their consent to participate in this study of their own free will.
3. Pregnant women who have fully understood the explanation provided on the web screen and have given their voluntary consent to participate in this study.
4. Pregnant women who are able to use smartphone applications.
5. Pregnant women who are less than 20 weeks pregnant and have come for an antenatal health checkup.

Exclude criteria

1. Pregnant women who are deemed inappropriate by the principal investigator, a research associate, or a physician in charge of the patient's care
2. Pregnant women who are judged to have difficulty participating in the study due to severe mental illness, etc.
3. Pregnant women who are deemed to be difficult to follow up for one year after childbirth
4. Pregnant women who plan to use other smoking cessation support materials or participate in smoking cessation activities during the study period
5. Pregnant women who are unable to use smartphone applications
6. Pregnant women who come for antenatal health checkups at 21 weeks of gestation or more.

Related Information

• Primary Sponsor: Sakai Hiroko
• Secondary Sponsor: Kawasaki Yuki