Helping pregnant women quit smoking to prevent obesity in infants

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study aims to evaluate the impact of smoking cessation during pregnancy and lactation on preventing rapid weight gain in infants. It involves a randomized controlled trial with smoking pregnant women, who will be assigned to either a multicomponent intervention group or an education-only control group. The intervention includes education, counseling, monitoring, financial incentives, and family support, while the control group receives only educational resources. Participants will be followed from their first prenatal visit through six months postpartum to assess maternal smoking cessation and infant weight gain.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Able to read, understand, and speak English.
2. Are 18-39 years old
3. Are less than 20 weeks of gestation
4. Have a singleton pregnancy
5. Currently smoking one or more cigarettes per day, based on self-report.
6. Currently smoking biochemically verified by a level of 1 or higher in urine cotinine test (i.e., \>100ng/mL cotinine concentration).
7. Willing to try to quit or reduce smoking by behavioral intervention
8. Willing to monitor smoking status by breath carbon monoxide and saliva cotinine.
9. Willing to provide breath, saliva, and urine samples to test smoking status
10. With low household income (meeting federal income eligibility guidelines for the Special Supplemental Nutrition Program for Women, Infants, and Children) and/or low education level (≤12 years). These disadvantaged pregnant women are very likely not to quit spontaneously, and thus need extra intervention most.
11. Currently living in Erie County or Niagara County; don't plan to move out of these two counties during the current pregnancy.

Exclusion Criteria:

1. Previous history of major chronic disease or blood clotting disorders such as cancer, thyroid disorders, heart disease, kidney disease
2. Depression or have been diagnosed with depression or post-partum depression at any time
3. In treatment for Axis 1 disorders that prevent them following smoking cessation interventions

Where it's running

• Division of Behavioral Medicine Department of Pediatrics Jacobs School of Medicine and Biomedical Sciences State University of New York at Buffalo
  Buffalo, New York, United States Recruiting

Study contacts

• Principal investigator: Xiaozhong Wen, MD, PhD — State University of New York at Buffalo
• Study coordinator: Xiaozhong Wen, MD, PhD
• Email: xiaozhon@buffalo.edu
• Phone: 7168296811

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.