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Preventing Postpartum Return to Smoking

Duke University · 2008
ClinicalTrials.gov · Datasets · License: Public Domain · 2008
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counselingpregnancypreventionwomen
STUDY PURPOSE: Aim 1. To assess the efficacy of an intervention in preventing or delaying postpartum smoking resumption among women who stop smoking during pregnancy. Aim 2. To determine the association of baseline risk assessment variables (dependence, motivation, self-efficacy, concerns for the fetus, changes in sensory response to tobacco, depression, weight concerns, and partner/household smoking and support) with time to resumption. A two-arm randomized controlled trial will be conducted. Women's risk for resumption will be assessed at 4 time-points. 1. Between 28 and 34 weeks of pregnancy 2. 6-weeks postpartum 3. 6-months postpartum 4. 12-months postpartum Women who report not smoking at any of the assessment points will be asked to provide a saliva sample for analysis of tobacco constituents and a breath sample to assess carbon monoxide. Bio-behavioral and pregnancy-specific factors will be used to triage women to one of four levels of stepped-care that includes: 1. One in-person counseling session and at least one telephone session during pregnancy and from 6 to 11 telephone sessions over the first 9-months postpartum. 2. Risk profiles will be used to match the intervention to each woman's needs. 3. Women randomized to the control arm will receive the booklet, Forever Free for Baby and Me and usual prenatal and postpartum care. We are recruiting 400 women for this study from 11 sites in the Durham/ Raleigh/ Chapel Hill NC area and Fayetteville NC.
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