Maternal Smoking Cessation and Pediatric Obesity Prevention
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-39
SponsorState University of New York at Buffalo
About this trial
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 criteria
This trial accepts healthy volunteersQualifiers
Able to read, understand, and speak English.
Are 18-39 years old
Are less than 20 weeks of gestation
Have a singleton pregnancy
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Multicomponent behavioral intervention
BehavioralPregnant 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.
Education only control
BehavioralThe 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.
Treatment groups
48 Participants
are divided into 2 treatment groupsGroup A: Multicomponent behavioral interventionExperimental treatment 1 intervention
Group B: ControlActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Self-reported Smoking abstinence verified by urine cotinine test
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 outcomes
1
Infant gain in weight-for-length z-score
Infant gain in weight-for-length z-score
Time frame
from birth to 12 monthsSponsors and contacts
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Source ClinicalTrials.gov