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Maternal Smoking Cessation and Pediatric Obesity Prevention

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03514602
Recruitment Status : Recruiting
First Posted : May 2, 2018
Last Update Posted : September 18, 2019
Sponsor:
Information provided by (Responsible Party):
Xiaozhong Wen, State University of New York at Buffalo

Tracking Information
First Submitted Date  ICMJE January 22, 2018
First Posted Date  ICMJE May 2, 2018
Last Update Posted Date September 18, 2019
Actual Study Start Date  ICMJE July 1, 2015
Estimated Primary Completion Date December 31, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 20, 2018)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03514602 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: April 20, 2018)
Infant gain in weight-for-length z-score [ Time Frame: from birth to 12 months ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Maternal Smoking Cessation and Pediatric Obesity Prevention
Official Title  ICMJE Pilot Study on Pediatric Obesity Prevention by Maternal Smoking Cessation in Pregnancy and Lactation
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 Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
Multicomponent behavioral intervention
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE
  • Childhood Obesity
  • Smoking, Cigarette
  • Pregnancy
Intervention  ICMJE
  • Behavioral: Multicomponent behavioral intervention
    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.
  • Behavioral: Education only control
    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.
Study Arms  ICMJE
  • Experimental: Multicomponent behavioral intervention
    The multicomponent intervention group will receive education and counseling, monitoring and feedback, contingent financial incentives, and family support.
    Intervention: Behavioral: Multicomponent behavioral intervention
  • Active Comparator: Control
    The control group will receive smoking cessation education only.
    Intervention: Behavioral: Education only control
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: April 20, 2018)
48
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 31, 2021
Estimated Primary Completion Date December 31, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Able to read, understand, and speak English.
  2. Are 18-39 years old
  3. Are less than 20 weeks of gestation
  4. Have a singleton pregnancy
  5. Currently smoking one or more cigarettes per day, based on self-report.
  6. Currently smoking biochemically verified by a level of 1 or higher in urine cotinine test (i.e., >100ng/mL cotinine concentration).
  7. Willing to try to quit or reduce smoking by behavioral intervention
  8. Willing to monitor smoking status by breath carbon monoxide and saliva cotinine.
  9. Willing to provide breath, saliva, and urine samples to test smoking status
  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. Currently living in Erie County or Niagara County; don't plan to move out of these two counties during the current pregnancy.

Exclusion Criteria:

  1. Previous history of major chronic disease or blood clotting disorders such as cancer, thyroid disorders, heart disease, kidney disease
  2. Depression or have been diagnosed with depression or post-partum depression at any time
  3. In treatment for Axis 1 disorders that prevent them following smoking cessation interventions
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years to 39 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Xiaozhong Wen, MD, PhD 7168296811 xiaozhon@buffalo.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03514602
Other Study ID Numbers  ICMJE MODCR00001304
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Xiaozhong Wen, State University of New York at Buffalo
Study Sponsor  ICMJE State University of New York at Buffalo
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Xiaozhong Wen, MD, PhD State University of New York at Buffalo
PRS Account State University of New York at Buffalo
Verification Date September 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP