Smoking Cessation Program During Pregnancy for Childhood Obesity Prevention
Trial Summary
What is the purpose of this trial?
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.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. However, it focuses on smoking cessation, so it might be best to discuss your medications with the trial coordinators.
What data supports the effectiveness of this treatment for smoking cessation during pregnancy?
Research shows that multicomponent interventions, which combine behavioral and pharmacological support, are more effective for quitting smoking than using just one type of therapy. Additionally, behavioral support has been found to help pregnant women stop smoking, although the specific techniques that work best are still being studied.12345
Is the multicomponent behavioral intervention for smoking cessation safe for humans?
The multicomponent behavioral intervention for smoking cessation, which includes education, counseling, and financial incentives, has been used safely in pregnant women to help them quit smoking. Participants in these programs have reported positive experiences, and no safety concerns have been highlighted in the studies.12467
How is the multicomponent behavioral intervention treatment for smoking cessation during pregnancy different from other treatments?
The multicomponent behavioral intervention for smoking cessation during pregnancy is unique because it combines various strategies like counseling, possibly with mobile technology support, to help pregnant women quit smoking, which is different from single-method approaches like nicotine replacement or hypnosis.1891011
Research Team
Xiaozhong Wen, MD, PhD
Principal Investigator
State University of New York at Buffalo
Eligibility Criteria
This trial is for English-speaking pregnant women aged 18-39, who smoke cigarettes, are less than 20 weeks pregnant with a single baby, and have low income or education. They must live in Erie or Niagara County and be willing to quit smoking using behavioral interventions and provide samples to confirm their smoking status. Women with major chronic diseases, blood clotting disorders, depression or other mental health conditions that could interfere with the study are not eligible.Inclusion Criteria
Exclusion Criteria
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment - Pregnancy
Participants receive a multicomponent intervention or education-only control during pregnancy to promote smoking cessation
Treatment - Lactation
Successful quitters from pregnancy phase receive continued intervention or education-only control during lactation
Follow-up
Participants are monitored for smoking abstinence and infant weight-for-length z-score gain
Treatment Details
Interventions
- Education only control (Behavioral Intervention)
- Multicomponent behavioral intervention (Behavioral Intervention)
Find a Clinic Near You
Who Is Running the Clinical Trial?
State University of New York at Buffalo
Lead Sponsor
Dr. Jonathan Slonin
State University of New York at Buffalo
Chief Medical Officer since 2020
MD from University of Miami, MBA from George Washington University
Stacy Knapper
State University of New York at Buffalo
Chief Executive Officer since 2023
BSEE from University of Puerto Rico-Mayagüez, MS in Management from Rensselaer Polytechnic Institute