Clinical Trial

Maternal Smoking Cessation and Pediatric Obesity Prevention

Study Description

Maternal Smoking Cessation and Pediatric Obesity Prevention

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.

Location

Locations Selected Location

Methods

No pharmaceutical medication involved No pharmaceutical medication involved
Patients and healthy individuals accepted Patients and healthy individuals accepted

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 qu ...read more on ClinicalTrials.org

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.

Additional Information

Official Study Title

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

Clinical Trial ID

NCT03514602

ParticipAid ID

vbmA3b