Financial Incentives for Smoking Cessation Among Disadvantaged Mothers With Young Children
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 198
- 试验地点
- 1
- 主要终点
- 7-day Point Prevalence Smoking Abstinence Levels
研究概览
简要总结
Investigators will examine whether adding financial incentives and nicotine replacement dual therapy to current best practices for smoking cessation (i.e. referral to counseling using a telephone quit line) increases cessation rates in mothers and reduces second-hand smoke exposure in children. While perhaps more expensive upfront compared to best practices alone, the investigators hypothesize that this treatment approach will be a more cost-effective cessation intervention.
详细描述
Smoking prevalence among disadvantaged mothers remains at strikingly high levels (40-60%). Disadvantaged women are more likely to begin smoking at an earlier age, be heavier smokers, be nicotine dependent, and fail in their efforts to quit smoking (Kandel et al., 2009). These women and their children also suffer higher rates of smoking-related adverse health consequences.
Despite widespread knowledge of the harmful effects of secondhand smoke exposure (SHSe), estimates are that 85% of children from low-income U.S. families experience chronic exposure. Children exposed to SHS are at increased risk for numerous serious health problems, including sudden infant death syndrome, more severe asthma, lower respiratory infections, and chronic middle ear disease, and maternal smoking is a particularly significant contributor to this increased morbidity and mortality. SHSe is also a substantial economic burden on the U.S. healthcare system, being estimated to increase direct medical and life-lost costs by > $5 billion annually.
Interventions developed to reduce children's SHSe have aimed to (1) decrease parental smoking around their children, (2) increase parental smoking cessation, or (3) both. Since smoking by a child's mother is a particularly significant contributor to SHSe, interventions have typically targeted smoking mothers. Regarding efforts to decrease smoking around children, studies testing relatively low-intensity interventions (e.g., written materials, brief advice) have failed to change exposure levels, while those testing more intensive interventions have had more success decreasing children's SHSe, with at least some instances of biochemically-verified changes.
Clearly, more effective smoking-cessation interventions for mothers are needed to meet the public health priority of reducing SHSe among children. The investigators recognize that maternal smoking cessation will not eliminate SHSe among children since many (~40%) live with more than one smoker. However, the evidence is clear that smoking mothers are the primary contributors to their children's SHSe, making them the obvious first target. The overarching goal of this project is to develop an efficacious, cost-effective incentive-based smoking cessation intervention that is combined with state-of-the-art smoking-cessation pharmacotherapy practices to optimize outcomes.
Participants will be 250 mothers (10 pilot and 80 per treatment condition) recruited from our university-affiliated hospital's pediatric practice, other pediatric and family medicine practices throughout the county in which our clinic is located, local offices for Women, Infants, and Children (WIC), and other recruitment strategies (e.g., ads on Facebook). Participants will be randomly assigned to one of three treatment conditions: (1) usual care for smoking cessation and protecting children from SHSe, (2) usual care combined with incentives for objectively verified smoking abstinence, and (3) usual care combined with incentives and pharmacotherapy using innovative procedures to enhance its efficacy.
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
- None
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
- •Expresses interest in quitting smoking
- •Express willingness to initiate NRT
- •Mother is ≥ 18 years of age
- •Self-reported smoking ≥ 10 cigarettes per day for ≥ 1 year, biochemically verified
- •Mother has a child < 12 years of age
- •Child resides with mother full-time
- •Not currently using any other tobacco cessation medications (e.g. Chantix) or NRT, or willing to stop use prior to participation in the study
- •Lives in Chittenden County, Vermont or surrounding counties
- •Plans on remaining in the geographical area for the next 12 months
- •English-speaking
- •Willing to let child participate in the study
排除标准
- •Failing to meet any of the above criteria
- •Has medical contraindications to NRT products
- •Meeting Diagnostic and Statistical Manual of Mental Disorders (DSM-IV) criteria for moderate or severe alcohol or drug dependence other than nicotine in the prior 12 months (those on opioid substitution therapy are allowed)
- •Current/past psychotic disorder
- •Being suicidal
- •Currently pregnant or trying to become pregnant in the next 12 months
- •Incarceration
- •Refusal to participate in study
研究组 & 干预措施
Best practices
Participants will receive the Five As plus a referral to a quit line.
干预措施: Best Practices (Behavioral)
Best practices and financial incentives
Participants will receive the Five As, a referral to a quit line, and financial incentives contingent on biochemically confirmed smoking abstinence
干预措施: Best Practices (Behavioral)
Best practices and financial incentives
Participants will receive the Five As, a referral to a quit line, and financial incentives contingent on biochemically confirmed smoking abstinence
干预措施: Financial Incentives (Behavioral)
Best practices, financial incentives, and NRT
Participants will receive the Five As, a referral to a quit line, financial incentives contingent on biochemically confirmed smoking abstinence, and nicotine replacement therapy (NRT) provided in the form of both nicotine patches and gum/lozenge for dual therapy.
干预措施: Best Practices (Behavioral)
Best practices, financial incentives, and NRT
Participants will receive the Five As, a referral to a quit line, financial incentives contingent on biochemically confirmed smoking abstinence, and nicotine replacement therapy (NRT) provided in the form of both nicotine patches and gum/lozenge for dual therapy.
干预措施: Financial Incentives (Behavioral)
Best practices, financial incentives, and NRT
Participants will receive the Five As, a referral to a quit line, financial incentives contingent on biochemically confirmed smoking abstinence, and nicotine replacement therapy (NRT) provided in the form of both nicotine patches and gum/lozenge for dual therapy.
干预措施: Nicotine Replacement Therapy (Drug)
结局指标
主要结局
7-day Point Prevalence Smoking Abstinence Levels
时间窗: Collected once per woman at approximately 12- and 24- weeks following quit date in each of the three smoking arms
Point prevalence abstinence will be defined as self-report of no smoking in the past 7 days, not even a puff, with biochemical verification via breath carbon monoxide (CO) and urine cotinine. Abstinence at the 12-week (end of treatment) and 24-week assessment will be compared between the three treatment arms.
Objective Measure of Child Secondhand Smoke Exposure (SHSe)
时间窗: Collected twice per child at baseline, and once at approximately 6-, 12- and 24-weeks following quit date
SHSe will be defined as the level of cotinine measured in the urine of the youngest child at baseline, 6-, 12-, and 24-weeks following the mother's quit date. SHSe outcomes will be compared between the three treatment arms and between children of abstainers versus smokers independent of treatment condition. We hypothesize being able to detect greater reductions from baseline levels in the incentives compared to Best Practices treatment conditions and among abstainers compared to smokers. We report main effects of treatment condition as geometric means (+/- SEM) collapsed across the three assessment times for each treatment condition controlling for baseline values.
次要结局
- 7-day Point Prevalence Abstinence at 48-week Follow-up Assessment(48 weeks following quit date)
- Smoking Abstinence(Collected once per woman at baseline, 6-, 12-, 24-, and 48-weeks following quit date.)
- Continuous Abstinence(24 weeks following quit date)
研究者
Stephen T. Higgins, PhD
Director of the Vermont Center on Behavior and Health and Vice Chair of Department of Psychiatry
University of Vermont
