Helping pregnant women quit smoking to prevent obesity in infants

Pilot Study on Pediatric Obesity Prevention by Maternal Smoking Cessation in Pregnancy and Lactation

This study is testing if helping pregnant women quit smoking can prevent their babies from gaining weight too quickly after birth.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 48 (estimated)
• Ages: 18 Years to 39 Years
• Sex: Female
• Sponsor: State University of New York at Buffalo (Academic / other)
• Locations: 1 site (Buffalo, New York)
• Trial ID: NCT03514602 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates for this study are pregnant women aged 18-39 who smoke and are less than 20 weeks gestation.

Not a fit: Patients who are not currently smoking or who are outside the specified age and gestational criteria may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved strategies for reducing childhood obesity by promoting smoking cessation among pregnant women.

How similar studies have performed: Other studies have shown that interventions targeting smoking cessation during pregnancy can be effective, suggesting potential success for this approach.

Eligibility criteria

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 this trial is running

Buffalo, New York

• 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

Conditions Childhood Obesity; Smoking, Cigarette; Pregnancy