Study to Help Pregnant Women Stop Using Both Cigarettes and E-cigarettes During the First Half of Pregnancy with Different Support Approaches

What this Trial Is About

Researchers are conducting a randomized controlled trial to develop and test a cessation program for pregnant women who currently use both cigarettes and nicotine-containing e-cigarettes. The study focuses on 45 pregnant mothers at 20 weeks gestation or less, with low household incomes, to evaluate two different strategies for quitting both products during pregnancy. The main goal is to determine if these interventions can increase nicotine abstinence rates compared to a control group. Participants will be randomly assigned to one of three groups simultaneous cessation intervention, stepwise cessation intervention, or control. The simultaneous group will target quitting cigarettes and e-cigarettes at the same time, while the stepwise group will first quit cigarettes and then e-cigarettes. Both intervention groups receive behavior counseling, biomarker feedback through urine cotinine and breath carbon monoxide monitoring, and financial incentives for verified abstinence. The control group receives behavior counseling only but completes the same number of study visits. Throughout the pregnancy until delivery, mothers will be followed with regular visits to monitor progress. Assessments include nicotine abstinence at 8 weeks after randomization, the time needed to achieve abstinence, gestational weight gain, and infant birth weight adjusted for gestational age. Researchers will use statistical analyses to compare outcomes across groups, controlling for various factors. The total participation duration covers pregnancy through delivery, with close monitoring of intervention adherence and verified abstinence.

Cessation of Dual Use of Cigarettes and E-cigarettes During Pregnancy