Maternal Smoking Cessation and Pediatric Obesity Prevention
Primary Purpose
Childhood Obesity, Smoking, Cigarette, Pregnancy
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Multicomponent behavioral intervention
Education only control
Sponsored by
About this trial
This is an interventional prevention trial for Childhood Obesity
Eligibility Criteria
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
Sites / Locations
- Division of Behavioral Medicine Department of Pediatrics Jacobs School of Medicine and Biomedical Sciences State University of New York at BuffaloRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Multicomponent behavioral intervention
Control
Arm Description
The multicomponent intervention group will receive education and counseling, monitoring and feedback, contingent financial incentives, and family support.
The control group will receive smoking cessation education only.
Outcomes
Primary Outcome Measures
Self-reported Smoking abstinence verified by urine cotinine test
Self-reported Smoking abstinence verified by urine cotinine test
Secondary Outcome Measures
Infant gain in weight-for-length z-score
Infant gain in weight-for-length z-score
Full Information
NCT ID
NCT03514602
First Posted
January 22, 2018
Last Updated
April 10, 2023
Sponsor
State University of New York at Buffalo
1. Study Identification
Unique Protocol Identification Number
NCT03514602
Brief Title
Maternal Smoking Cessation and Pediatric Obesity Prevention
Official Title
Pilot Study on Pediatric Obesity Prevention by Maternal Smoking Cessation in Pregnancy and Lactation
Study Type
Interventional
2. Study Status
Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 1, 2015 (Actual)
Primary Completion Date
December 31, 2024 (Anticipated)
Study Completion Date
December 31, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
State University of New York at Buffalo
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Childhood Obesity, Smoking, Cigarette, Pregnancy
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Multicomponent behavioral intervention
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
48 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Multicomponent behavioral intervention
Arm Type
Experimental
Arm Description
The multicomponent intervention group will receive education and counseling, monitoring and feedback, contingent financial incentives, and family support.
Arm Title
Control
Arm Type
Active Comparator
Arm Description
The control group will receive smoking cessation education only.
Intervention Type
Behavioral
Intervention Name(s)
Multicomponent behavioral intervention
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Education only control
Intervention Description
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.
Primary Outcome Measure Information:
Title
Self-reported Smoking abstinence verified by urine cotinine test
Description
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)
Secondary Outcome Measure Information:
Title
Infant gain in weight-for-length z-score
Description
Infant gain in weight-for-length z-score
Time Frame
from birth to 12 months
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
39 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Xiaozhong Wen, MD, PhD
Phone
7168296811
Email
xiaozhon@buffalo.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Xiaozhong Wen, MD, PhD
Organizational Affiliation
State University of New York at Buffalo
Official's Role
Principal Investigator
Facility Information:
Facility Name
Division of Behavioral Medicine Department of Pediatrics Jacobs School of Medicine and Biomedical Sciences State University of New York at Buffalo
City
Buffalo
State/Province
New York
ZIP/Postal Code
14214
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xiaozhong Wen
Phone
716-829-6811
Email
xiaozhon@buffalo.edu
First Name & Middle Initial & Last Name & Degree
Xiaozhong Wen
Phone
7168296811
First Name & Middle Initial & Last Name & Degree
Xiaozhong Wen, MD, PhD
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Maternal Smoking Cessation and Pediatric Obesity Prevention
We'll reach out to this number within 24 hrs