Maternal Smoking Cessation and Pediatric Obesity Prevention
Pilot Study on Pediatric Obesity Prevention by Maternal Smoking Cessation in Pregnancy and Lactation
Who can join
As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.
- Age
- 18 Years to 39 Years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Compensation
- Not stated
Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.
What to expect
No one can promise a trial will help you personally — that is what the research is trying to find out.
What participation involves
Not stated in the study description — ask the study team about visits and procedures.
- Compensation
- Not stated
- Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
- Participants are monitored closely by the research team throughout the study.
- Some participants may receive access to an investigational treatment, which is still being studied.
- Your participation helps researchers learn whether this approach could help future patients.
About this study
In plain language
This study tests whether help to quit smoking during pregnancy or breastfeeding can prevent babies from gaining body fat too quickly. It is for pregnant women who smoke, and it follows mothers and babies until 6 months after birth. The study compares education alone with education plus counseling, smoking checks, money rewards, and family support.
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.
Compensation is read from the study's own description and may be missing — always confirm with the study team.
Eligibility
Who can join
- Can read, understand, and speak English.
- Are 18–39 years old, less than 20 weeks pregnant, and carrying one baby.
- Report smoking at least one cigarette a day.
- Have a urine test showing cotinine, a sign of nicotine use, above 100 ng/mL.
- Are willing to try to quit or cut down on smoking with help to change habits.
- Are willing to have smoking checks and give breath, saliva, and urine samples.
- Have household income low enough to qualify for WIC, a food support program, and/or have 12 years of schooling or less.
- Live in Erie County or Niagara County and do not plan to move outside these counties during pregnancy.
Who can't join
- Have a history of a major long-term illness or a blood-clotting disorder, such as cancer, thyroid disease, heart disease, or kidney disease.
- Have depression now or have ever been diagnosed with depression, including depression after childbirth.
- Are being treated for an Axis I mental health disorder that keeps you from following the study’s quit-smoking program.
Simplified for readability. The official criteria below are what the study team uses.
Official 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
Study sites (1)
NY
- Division of Behavioral Medicine Department of Pediatrics Jacobs School of Medicine and Biomedical Sciences State University of New York at Buffalo · Buffalo, NY 14214Xiaozhong Wen · Study contact · 7168296811 · xiaozhon@buffalo.eduXiaozhong Wen · Study contact · 7168296811Xiaozhong Wen, MD, PhD · Principal investigatorMore trials in Buffalo