Preventing Postpartum Return to Smoking
Completed · Not applicable
Conditions studied: Smoking
In brief
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.
Key facts
- Study ID
- NCT00917943
- Run by
- Duke University
- People needed
- 386
- Starts
- 2008-04-01
- Expected to finish
- 2012-12-01
- Last updated by the study team
- 2013-04-10
Who can join
Age: 18 and older. Sex: female. Healthy volunteers: accepted.
You may qualify if…
- 18 years of age or older
- Speak English
- Registered for prenatal care
- Have a history of smoking (defined as having smoked at least 100 cigarettes in their lifetimes and at least 5 cigarettes a day prior to becoming pregnant)
- Will need to have been continuously abstinent from tobacco for at least 1 month prior to their risk assessment
- Women will be eligible if they stopped smoking upon learning of their pregnancies and have been continuously abstinent (self-initiated quitters), or if they continued to smoke during the first few months of pregnancy but have been continuously abstinent from 24 to 28 weeks.
You may not qualify if…
- Any women who stopped smoking and resumed by the 34-week risk assessment will be ineligible.
Where it is running
- Duke University Medical Center — Durham, North Carolina, United States
Full record on ClinicalTrials.gov
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