RECRUITING

Maternal Smoking Cessation and Pediatric Obesity Prevention

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Conditions

Childhood ObesitySmoking, CigarettePregnancy

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

Pilot Study on Pediatric Obesity Prevention by Maternal Smoking Cessation in Pregnancy and Lactation

Quick Facts

Study Start:2015-07-01
Study Completion:2025-12-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT03514602

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.

Ages Eligible for Study:18 Years to 39 Years
Sexes Eligible for Study:FEMALE
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. Able to read, understand, and speak English.
  2. 2. Are 18-39 years old
  3. 3. Are less than 20 weeks of gestation
  4. 4. Have a singleton pregnancy
  5. 5. Currently smoking one or more cigarettes per day, based on self-report.
  6. 6. Currently smoking biochemically verified by a level of 1 or higher in urine cotinine test (i.e., \>100ng/mL cotinine concentration).
  7. 7. Willing to try to quit or reduce smoking by behavioral intervention
  8. 8. Willing to monitor smoking status by breath carbon monoxide and saliva cotinine.
  9. 9. Willing to provide breath, saliva, and urine samples to test smoking status
  10. 10. 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.
  11. 11. Currently living in Erie County or Niagara County; don't plan to move out of these two counties during the current pregnancy.
  1. 1. Previous history of major chronic disease or blood clotting disorders such as cancer, thyroid disorders, heart disease, kidney disease
  2. 2. Depression or have been diagnosed with depression or post-partum depression at any time
  3. 3. In treatment for Axis 1 disorders that prevent them following smoking cessation interventions

Contacts and Locations

Study Contact

Xiaozhong Wen, MD, PhD
CONTACT
7168296811
xiaozhon@buffalo.edu

Principal Investigator

Xiaozhong Wen, MD, PhD
PRINCIPAL_INVESTIGATOR
State University of New York at Buffalo

Study Locations (Sites)

Division of Behavioral Medicine Department of Pediatrics Jacobs School of Medicine and Biomedical Sciences State University of New York at Buffalo
Buffalo, New York, 14214
United States

Collaborators and Investigators

Sponsor: State University of New York at Buffalo

  • Xiaozhong Wen, MD, PhD, PRINCIPAL_INVESTIGATOR, 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 Registration Dates

Study Start Date2015-07-01
Study Completion Date2025-12-31

Study Record Updates

Study Start Date2015-07-01
Study Completion Date2025-12-31

Terms related to this study

Additional Relevant MeSH Terms

  • Childhood Obesity
  • Smoking, Cigarette
  • Pregnancy