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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

Must not have

Depression or have been diagnosed with depression or post-partum depression at any time

In treatment for Axis 1 disorders that prevent them following smoking cessation interventions

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from birth to 12 months

Awards & highlights

No Placebo-Only Group

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.

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.

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

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I am between 18 and 39 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have been diagnosed with depression, including post-partum depression.

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I am receiving treatment for a mental health disorder that makes it hard for me to quit smoking.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from birth to 12 months

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Self-reported Smoking abstinence verified by urine cotinine test

Secondary study objectives

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.

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

State University of New York at BuffaloLead Sponsor

268 Previous Clinical Trials

51,593 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.