NCT03514602 Maternal Smoking Cessation and Pediatric Obesity Prevention
| NCT ID | NCT03514602 |
| Status | Recruiting |
| Phase | — |
| Sponsor | State University of New York at Buffalo |
| Condition | Childhood Obesity |
| Study Type | INTERVENTIONAL |
| Enrollment | 48 participants |
| Start Date | 2015-07-01 |
| Primary Completion | 2026-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 48 participants in total. It began in 2015-07-01 with a primary completion date of 2026-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
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
Contact & Investigator
Xiaozhong Wen, MD, PhD
PRINCIPAL INVESTIGATOR
State University of New York at Buffalo
Frequently Asked Questions
Who can join the NCT03514602 clinical trial?
This trial is open to female participants only, aged 18 Years or older, up to 39 Years, studying Childhood Obesity. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT03514602 currently recruiting?
Yes, NCT03514602 is actively recruiting participants. Contact the research team at xiaozhon@buffalo.edu for enrollment information.
Where is the NCT03514602 trial being conducted?
This trial is being conducted at Buffalo, United States.
Who is sponsoring the NCT03514602 clinical trial?
NCT03514602 is sponsored by State University of New York at Buffalo. The principal investigator is Xiaozhong Wen, MD, PhD at State University of New York at Buffalo. The trial plans to enroll 48 participants.
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