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Smoking Cessation Program During Pregnancy for Childhood Obesity Prevention

N/A
Recruiting
Led By Xiaozhong Wen, MD, PhD
Research Sponsored by State University of New York at Buffalo
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Aged 18-39 years
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from birth to 12 months
Awards & highlights
No Placebo-Only Group

Study Summary

This trial is testing whether or not smoking cessation during pregnancy or lactation prevents rapid infant adiposity gain. 40 smoking pregnant women will be randomly assigned to either a multicomponent intervention group or an education-only control group. The multicomponent intervention group will receive education and counseling, monitoring and feedback, contingent financial incentives, and family support. If the woman successfully quits smoking, she will be randomized into the continuous multicomponent intervention group in lactation or the education-only control group. The key outcomes include maternal smoking abstinence confirmed by urine-cotinine and infant gain in weight-for-length z-score.

Who is the study for?
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.Check my eligibility
What is being tested?
The study tests if quitting smoking during pregnancy or lactation can prevent rapid weight gain in infants. It involves two phases: first comparing a multicomponent intervention (education, counseling, monitoring/feedback, financial incentives) against an education-only control during pregnancy; then among those who quit successfully by end of pregnancy further randomization into continuous intervention or control during lactation.See study design
What are the potential side effects?
Since this trial focuses on behavioral interventions rather than medications there may not be direct side effects like those seen with drugs. However participants might experience stress or discomfort related to attempting to change behavior such as quitting smoking.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am between 18 and 39 years old.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from birth to 12 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and from birth to 12 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Self-reported Smoking abstinence verified by urine cotinine test
Secondary outcome measures
Infant gain in weight-for-length z-score

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Multicomponent behavioral interventionExperimental Treatment1 Intervention
The multicomponent intervention group will receive education and counseling, monitoring and feedback, contingent financial incentives, and family support.
Group II: ControlActive Control1 Intervention
The control group will receive smoking cessation education only.

Find a Location

Who is running the clinical trial?

State University of New York at BuffaloLead Sponsor
244 Previous Clinical Trials
49,497 Total Patients Enrolled
Xiaozhong Wen, MD, PhD3.724 ReviewsPrincipal Investigator - State University of New York at Buffalo
State University of New York at Buffalo
1 Previous Clinical Trials
40 Total Patients Enrolled
5Patient Review
Dr. Wen is extremely knowledgeable and cares about your overall health, not just your immediate problem. She has been my primary physician for over 10 years.

Media Library

Smoking/Cigarette Smoking Research Study Groups: Multicomponent behavioral intervention, Control

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is enrollment still ongoing for this research experiment?

"According to the official record on clinicaltrials.gov, this study is actively enrolling participants and has been since July 1st 2015. The most recent update was made March 2nd 2022."

Answered by AI

Who is qualified to partake in this scientific experiment?

"This medical research project is recruiting 48 individuals aged 18-39 that have a habit of smoking cigarettes. To be considered, participants must also conform to the following criteria: disposing to attempt quitting or reducing cigarette consumption through behavioural modification; meeting federal guidelines for low income households and/or having achieved ≤12 years education level; being less than 20 weeks pregnant with a singleton pregnancy; self-reporting one or more daily cigarettes smoked. These expectant mothers are highly unlikely to cease their nicotine intake without adequate intervention."

Answered by AI

Would participants aged eighty-five and above be accepted into this research endeavor?

"In accordance with the study's requirements, only those between 18 and 39 years old are eligible for enrollment in this trial."

Answered by AI

How many people are enrolled in this clinical experimentation?

"Affirmative. Clinicaltrials.gov data shows that this clinical trial, first posted on July 1st 2015, is currently enrolling patients. 48 individuals are being accepted at a single medical centre."

Answered by AI
~4 spots leftby Dec 2024