Smoking Cessation for Low-Income Pregnant Women
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 277
- 试验地点
- 2
- 主要终点
- Smoking Cessation Status
研究概览
简要总结
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.
详细描述
Rates of Smoking Among Pregnant and Postpartum Women.
Despite the well-established health risks of prenatal and postpartum smoking, a sizable number of pregnant women and new mothers smoke. About 30% of US women who become pregnant smoke. Only 20-40% of these women spontaneously quit upon learning of their pregnancy. Although an additional 3-16% of pregnant smokers may quit later in pregnancy, the majority continue to smoke throughout, with 15-30% relapsing. Research has also indicated that smoking cessation rates are lower among low-income pregnant women (6-14%) versus more affluent populations. Less educated, lower SES, unemployed women who have a higher addiction to nicotine are at greatest risk for smoking throughout their pregnancy, while pregnant women with higher levels of education and income are more likely to quit. These differential smoking rates result in elevated rates of high-risk pregnancies for low SES and less educated women, vs. higher SES and educated women. While some research has demonstrated moderate success with prenatal smoking cessation interventions, relapse remains a prominent concern. Indeed, more than a quarter of women who quit spontaneously relapse by 6-weeks postpartum, with relapse rates reported as high as 60-80% by 6-months postpartum. The highest relapse rates have been found among women with low income and little education.
Smoking Cessation Interventions for Prenatal and Postpartum Women.
To date, the efficacy of available smoking cessation interventions has been disappointing. The current literature on tobacco control indicates that cognitive-affective factors (including perceived risk, self-efficacy, fatalism, decisional balance, and affect) need to be considered when designing smoking cessation protocols. Yet, the behavioral treatments that have been tested for pregnant smokers focus on the use of self-help guides, basic skills training, and education, neglecting the individual's cognitive-affective profile of barriers. This limitation is paralleled by a similar void in the broader smoking cessation literature. When these characteristics are addressed, they have been considered in isolation, without attention to the full spectrum of cognitive-affective barriers to quitting (i.e., the interventions focus on only 1 barrier such as perceived risk or depression). Not surprisingly, among intervention studies with pregnant women, only 3 produced quit rates above 20%.
Thus, research now needs to build upon these guidelines to develop more potent smoking cessation interventions. The design of our intervention is directly responsive to the call for the development of more creative and powerful behavioral interventions to replace the current best available programs. Guided by the Cognitive-Social Health Information Processing (C-SHIP) model and based on our related behavior change protocols for low-income populations, our approach is tailored to the woman's cognitive-affective profile of barriers to initial, and sustained, uptake of smoking cessation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —(Adult, Older Adult)
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Being pregnant
- •Having smoked one puff of a cigarette in the 30 days prior to recruitment (1- 25 weeks post-gestation)
- •Being 18 years or older
- •Being reachable by a telephone.
排除标准
- •An inability to communicate readily in English
- •Receiving substance abuse treatment and/or evidence of drug and alcohol abuse
研究组 & 干预措施
Cognitive-Behavioral Counseling (CBC)
Cognitive-Behavioral Counseling (CBC) consists of two 45-minute on-site intervention sessions (session 1 and 3), one 15 minute on-site session (session 2), and one 15-minutes phone session (booster session).
干预措施: Cognitive-Behavioral Counseling (CBC) (Behavioral)
Best Practice (BP) Control
Best Practice (BP) Control Condition consists of two 10-15 min, on-site intervention sessions (session 1 and 3), one brochure pick-up (session 2), and receipt of a newsletter by mail (booster session).
干预措施: Best Practice (BC) Control (Behavioral)
结局指标
主要结局
Smoking Cessation Status
时间窗: 3-month post intervention follow up (20-22 weeks postpartum)
Self-reported quit status will be assessed using continuous abstinence and 7-day point prevalence. Assessment of continuous abstinence consists of interviewing the participant to record their smoking practices on each day from the preceding data point to the current interview date (e.g., duration between the quit date and the end of treatment). In addition, saliva cotinine level will be examined to validate self-report smoking status. Participants with a cotinine level of 10mg or above will be considered smokers. In the case of discrepancies between self-report and biochemical verification from saliva samples, the cotinine level will be used as the criterion.
次要结局
- Average Number of Cigarettes Smoked Per Day in Past 7 Days(3-month post intervention follow up (20-22 weeks postpartum))
