- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03514602
Maternal Smoking Cessation and Pediatric Obesity Prevention
April 10, 2023 updated by: Xiaozhong Wen, State University of New York at Buffalo
Pilot Study on Pediatric Obesity Prevention by Maternal Smoking Cessation in Pregnancy and Lactation
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.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Detailed Description
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.
Study Type
Interventional
Enrollment (Anticipated)
48
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Xiaozhong Wen, MD, PhD
- Phone Number: 7168296811
- Email: xiaozhon@buffalo.edu
Study Locations
-
-
New York
-
Buffalo, New York, United States, 14214
- Recruiting
- Division of Behavioral Medicine Department of Pediatrics Jacobs School of Medicine and Biomedical Sciences State University of New York at Buffalo
-
Contact:
- Xiaozhong Wen
- Phone Number: 716-829-6811
- Email: xiaozhon@buffalo.edu
-
Contact:
- Xiaozhong Wen
- Phone Number: 7168296811
-
Principal Investigator:
- Xiaozhong Wen, MD, PhD
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 39 years (Adult)
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- Able to read, understand, and speak English.
- Are 18-39 years old
- Are less than 20 weeks of gestation
- Have a singleton pregnancy
- Currently smoking one or more cigarettes per day, based on self-report.
- Currently smoking biochemically verified by a level of 1 or higher in urine cotinine test (i.e., >100ng/mL cotinine concentration).
- Willing to try to quit or reduce smoking by behavioral intervention
- Willing to monitor smoking status by breath carbon monoxide and saliva cotinine.
- Willing to provide breath, saliva, and urine samples to test smoking status
- 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.
- Currently living in Erie County or Niagara County; don't plan to move out of these two counties during the current pregnancy.
Exclusion Criteria:
- Previous history of major chronic disease or blood clotting disorders such as cancer, thyroid disorders, heart disease, kidney disease
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Multicomponent behavioral intervention
The multicomponent intervention group will receive education and counseling, monitoring and feedback, contingent financial incentives, and family support.
|
Pregnant patients in the intervention group will receive multicomponent interventions consisting of education, feedback, contingent financial incentives, and peer support.
At initial intervention visit, they will choose a quit date within the next 14 days and sign a no-smoking pledge and a no-smoking contract.
The contract lists the intervention components, the patient's and the counselor's responsibilities, importance of keeping scheduled visits, and rules on contingent incentives.
After the quit date, pregnant women will meet with counselors daily for 5 consecutive days (Monday to Friday) for abstinence monitoring in weeks 1-2.
The frequency of abstinence monitoring will decrease to twice a week (Monday and Thursday) in weeks 3-8, weekly in weeks 9-12, and biweekly in weeks 13 until delivery.
|
Active Comparator: Control
The control group will receive smoking cessation education only.
|
The control group will receive one 60-minute counseling mainly based on a pregnancy-tailored self-help booklet entitled "Need Help Putting Out That Cigarette?"
distributed by the American College of Obstetricians and Gynecologists.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Self-reported Smoking abstinence verified by urine cotinine test
Time Frame: At end of pregnancy (35 weeks of pregnancy; an average of 10 weeks after intervention)
|
Self-reported Smoking abstinence verified by urine cotinine test
|
At end of pregnancy (35 weeks of pregnancy; an average of 10 weeks after intervention)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Infant gain in weight-for-length z-score
Time Frame: from birth to 12 months
|
Infant gain in weight-for-length z-score
|
from birth to 12 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Xiaozhong Wen, MD, PhD, State University of New York at Buffalo
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
July 1, 2015
Primary Completion (Anticipated)
December 31, 2024
Study Completion (Anticipated)
December 31, 2024
Study Registration Dates
First Submitted
January 22, 2018
First Submitted That Met QC Criteria
April 20, 2018
First Posted (Actual)
May 2, 2018
Study Record Updates
Last Update Posted (Actual)
April 11, 2023
Last Update Submitted That Met QC Criteria
April 10, 2023
Last Verified
April 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- MODCR00001304
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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