Smoking Cessation for Low-Income Pregnant Women
NCT02211430 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 277
Last updated 2014-08-07
Summary
To meet the Healthy People 2010 objective of increasing tobacco abstinence among pregnant women to 90%, new methods for treating nicotine addiction among pregnant women are needed. To this end, we propose to evaluate an innovative cognitive-behavioral smoking cessation intervention for low-income, minority women conducted in the prenatal and postpartum phases. Considering the strong link between tobacco use and cancer risk, the development of effective smoking cessation treatments has important health implications for cancer prevention and control initiatives. The aims to be addressed are:
Aim 1: To compare an enhanced Cognitive-Behavioral Counseling (CBC) smoking cessation intervention with a Best Practice control condition (BP) for reducing smoking rates (i.e., continued abstinence, 7-day point prevalence, and number of cigarettes smoked) in the short- and long-term among pregnant women. It is hypothesized that smokers receiving CBC will show reduced rates of tobacco use, versus those in the BP, over time.
Aim 2: To evaluate the impact of the CBC intervention on the hypothesized mediators of behavior change (i.e., heightened risk perceptions; enhanced self-efficacy and reduced fatalistic beliefs; high pros and low cons of quitting; reduced emotional distress). It is hypothesized that the psychosocial factors will mediate the effect of the CBC intervention on change of smoking behaviors.
Conditions
- Pregnancy
- Smoking
Interventions
- BEHAVIORAL
-
Cognitive-Behavioral Counseling (CBC)
Participants of CBC were educated about the effects of smoking on their personal health and their pregnancy during session 1 (45 minutes counseling), and were encouraged to explore their risk perceptions and emotions, for themselves and their unborn child. During session 2, the 15-minute counseling segment highlighted the cognitive and emotion barriers undermining the participant's motivation to quit and the self-regulatory techniques for resisting personal smoking triggers. Session 3 (45 minutes counseling) involved reviewing smoking status and smoking history over the course of the pregnancy, as well as the effects of smoking on both their health and the health of their infant. Booster session was held by phone for 15 min.
- BEHAVIORAL
-
Best Practice (BC) Control
For ethical considerations, and consistent with practice guidelines for treating tobacco addiction (Fiore et al., 2000) which mandates that every pregnant smoker be offered smoking cessation treatment, the control group has been designed to be comparable to the current "best practice" guidelines for smoking cessation treatments. This condition, devised from a review of the current literature, will include one brief (5-15 minutes) prenatal individual session (session 1) consisting of smoking cessation education and advice, on-site brochure pick up (session 2), and a second brief postpartum individual session (session 3) followed by receipt of a newsletter (session 4).
Sponsors & Collaborators
-
Fox Chase Cancer Center
lead OTHER
Principal Investigators
-
Suzanne Miller, Ph.D. · Fox Chase Cancer Center
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- SINGLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- FEMALE
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2002-10-31
- Primary Completion
- 2007-03-31
- Completion
- 2007-03-31
Countries
- United States
Study Locations
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