RecruitingNot ApplicableNCT03514602

Maternal Smoking Cessation and Pediatric Obesity Prevention

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


Sponsor

State University of New York at Buffalo

Enrollment

48 participants

Start Date

Jul 1, 2015

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Sex: FEMALEMin Age: 18 YearsMax Age: 39 Years

Plain Language Summary

Simplified for easier understanding

This study investigates whether supporting pregnant women who smoke to quit during pregnancy — and then continuing that support through breastfeeding — reduces the risk of their babies gaining excess weight (fat) in the first 6 months of life, which is an early risk factor for childhood obesity. The program combines counseling, financial incentives, monitoring, and family support to help women quit smoking. Women aged 18 to 39 who are less than 20 weeks pregnant, currently smoke, have low income or education levels, and live in Erie or Niagara County, New York may be eligible, while those with major chronic illnesses, depression history, or psychiatric conditions are excluded. Participation involves being randomly assigned to an intensive smoking cessation program or an education-only group, with follow-up of both mother and infant through 6 months postpartum. This summary was generated with AI assistance to help patients understand the study in plain language.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BEHAVIORALMulticomponent 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.

BEHAVIORALEducation 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.


Locations(1)

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

Buffalo, New York, United States

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NCT03514602


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