Actively Recruiting
Maternal Smoking Cessation and Pediatric Obesity Prevention
Led by State University of New York at Buffalo · Updated on 2025-07-30
48
Participants Needed
1
Research Sites
600 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The objective of this study is to test the effect of smoking cessation in pregnancy or in lactation on preventing rapid infant adiposity gain. Investigators propose a randomized, controlled experiment among smoking pregnant women from 1st prenatal care visit through 6 months of postpartum period. Two-phase randomization will be applied to separate the effects of smoking cessation in two different critical periods (i.e., pregnancy and lactation) on infant adiposity gain. Investigators will first randomly assign 40 smoking pregnant women into either the multicomponent intervention (N=30) or the education-only control group (N=10). The multicomponent intervention group will receive education and counseling, monitoring and feedback, contingent financial incentives, and family support, while the control group will receive education only. At the end of pregnancy, investigators will further randomize successful quitters (estimated N=20) from the multi-component intervention group into either the continuous multi-component intervention group in lactation (N=10) or the education-only control group (N=10). All women and their newborns will be followed from enrollment to 6 months postpartum. The key outcomes include maternal smoking abstinence confirmed by urine-cotinine and infant gain in weight-for-length z-score. Specific Aim 1 is to examine the effects of maternal smoking cessation intervention in pregnancy on infant gain in weight-for-length z-score from birth to 6 months. Specific Aim 2 is to examine the effect of maternal smoking abstinence intervention in lactation and infant post-weaning gain in weight-for-length z-score among the women who have successfully quit smoking in pregnancy.
CONDITIONS
Official Title
Maternal Smoking Cessation and Pediatric Obesity Prevention
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Able to read, understand, and speak English.
- Age between 18 and 39 years.
- Less than 20 weeks pregnant.
- Pregnant with a single baby.
- Currently smoking one or more cigarettes daily by self-report.
- Smoking confirmed by urine cotinine level above 100 ng/mL.
- Willing to try quitting or reducing smoking through behavioral intervention.
- Willing to monitor smoking status using breath carbon monoxide and saliva cotinine.
- Willing to provide breath, saliva, and urine samples for smoking tests.
- Low household income as defined by federal guidelines and/or education level of 12 years or less.
- Living in Erie County or Niagara County and not planning to move during pregnancy.
You will not qualify if you...
- History of major chronic diseases or blood clotting disorders like cancer, thyroid, heart, or kidney disease.
- Diagnosed with depression or postpartum depression at any time.
- Currently in treatment for Axis 1 disorders that interfere with following smoking cessation interventions.
AI-Screening
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Trial Site Locations
Total: 1 location
1
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, 14214
Actively Recruiting
Research Team
X
Xiaozhong Wen, MD, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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