N/A
N=40
Lung and Breast Cancer Prevention by an Integrated Intervention of Maternal Smoking Cessation and Breastfeeding
Smoking, Cigarette · Breastfeeding
Bottom Line
View on ClinicalTrials.gov: NCT05123118 ↗Enrolled (actual)
40
Serious AEs
0.0%
Results posted
Apr 2025
Primary outcome: Primary: Number of Participants With Smoking Abstinence — 8; 3 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Integrated intervention of smoking cessation and breastfeeding (Behavioral); Attention placebo control (Behavioral)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- Xiaozhong Wen
- Primary completion
- Oct 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Smoking Abstinence |
8; 3 | — |
| PRIMARY Number of Participants With Reported Intent to Breastfeed |
16; 10 | — |
| PRIMARY Number of Participants Reporting to Breastfeed |
6; 3 | — |
Summary
This pilot clinical trial aims to integrate maternal smoking cessation and breastfeeding interventions to enhance both cancer prevention behaviors. The investigators will recruit 40 daily smoking women in their early pregnancy and randomize them into the integrated intervention or control group. Main outcomes include smoking abstinence and breastfeeding rates at 6 months postpartum.
Eligibility Criteria
Inclusion Criteria
- Be 18 years or older
- At ≤28 weeks of pregnancy
- Daily smoking cigarettes and/or cigars in the past 7 days
- Be able to read, listen, and talk in English
Exclusion Criteria
- Being diagnosed with cancer
- Current heavy drinking (more than 2 drinks a day)
- Current use of illicit substances
- Medical conditions contraindicating breastfeeding such as HIV infection, active tuberculosis, and breast removal
Data sourced from ClinicalTrials.gov (NCT05123118). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.