We propose a randomized controlled trial to develop and evaluate a cessation program with two different strategies for dual users during pregnancy. We plan to enroll 45 pregnant mothers (≤20 gestational weeks) with low household incomes from the Western NY region. To be eligible, they must be currently dual using CCs and nicotine-containing ECs. These mothers will be randomized into one of three groups: 1) simultaneous cessation intervention group (N=15), 2) stepwise cessation intervention group (N=15), and 3) control group (N=15). We hypothesize that nicotine abstinence rates at 8 weeks after randomization will be higher in the intervention groups than in the control group.
Less than 21 weeks pregnant to ensure adequate time for intervention;
18 years or older;
Actively using both cigarettes and electronic cigarettes (e-cigarettes);
Willing to receive cessation information;
Teen pregnancy (<18 y);
Unstable housing;
Uncontrolled mental health disorders;
Non-English speakers.
Parallel
Simultaneous cessation intervention
BehavioralThis simultaneous cessation intervention group will target CCs and ECs at the same time. Participants in this group will receive a multi-component cessation intervention, including behavior counseling, biomarker feedback via monitoring changes in levels of exposure to nicotine (urine cotinine) and CC smoke (breath carbon monoxide), and contingent financial incentives for biochemically verified abstinence.
Stepwise cessation intervention
BehavioralThis stepwise cessation intervention group will first target CCs and then target ECs after quitting CCs. Participants in this group will receive a multi-component cessation intervention, including behavior counseling, biomarker feedback via monitoring changes in levels of exposure to nicotine (urine cotinine) and CC smoke (breath carbon monoxide), and contingent financial incentives for biochemically verified abstinence.
Behavior counseling only
BehavioralParticipants assigned to the control group will receive behavior counseling only. They will complete the same number of study visits as their counterparts in the intervention groups.
Nicotine abstinence
Research staff who are blinded to the participant's group assignment will administer a timeline follow-back interview (trained by the PI, Dr. Wen) to assess the participant's recent smoking and vaping history. Based on self-reports, we will classify smoking and vaping status in the past 7 days (7-day point prevalence) prior to the outcome assessment visits at pre-test, 8 weeks after randomization, and at the end of pregnancy. To confirm self-reported complete nicotine abstinence (i.e., abstinence from both ECs and CCs), 5.0 mL of urine samples will be collected at study visits in the 8th week after randomization and at the end of pregnancy (approximately 35 weeks). An HPLC-MS/MS assay will be used as a gold standard test to determine urine cotinine levels.
The time needed to achieve nicotine abstinence
We define the time needed to achieve nicotine abstinence as the interval between the day of randomization and the first day of complete nicotine abstinence ("not even a puff") without any relapse until birth delivery.
The mother's gestational weight gain
Total gestational weight gain (GWG) will be calculated as the difference between weight right before delivery and pre-pregnancy weight. Based on 2009 the Institute of Medicine (IOM) guidelines, we will define inadequate GWG as total GWG less than 28, 25, 15, and 11 pounds for underweight (pre-pregnancy BMI\<18.5 kg/ m2), normal weight (BMI 18.5-24.9), overweight (BMI 25-29.9), and obese mothers (BMI ≥30), respectively.
The infant's birth-weight-forgestational- age z score
We will obtain the infant's gestational age, clinical measures on weight, length, and head circumference at birth from delivery records. Gestational age will be calculated as the interval between the self-reported last menstrual period and delivery date. We will calculate the infant's birth-weight-for-gestational-age z score and percentile for the same sex and gestational age. SGA will be defined as birth weight below the 10th percentile.
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State University of New York at Buffalo
Lead sponsor
National Center for Advancing Translational Sciences (NCATS)
Collaborator
