Smartphone-based Financial Incentives to Promote Smoking Cessation Among Alaska Native Pregnant Women
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 5
- 试验地点
- 4
- 主要终点
- Late Pregnancy Quit Rate
研究概览
简要总结
Cigarette smoking during pregnancy increases risk for catastrophic pregnancy complications, growth retardation, other adverse infant health problems, and later-in-life chronic conditions. One group that is particularly at risk for these complications are Alaska Native (AN) women. Prevalence of smoking during pregnancy is disproportionally high among AN women compared to US pregnant women overall (i.e., ~36% and ~13%, respectively) and few smoking-cessation interventions have been evaluated among this population. A substantive barrier to offering evidence-based interventions to AN women is the geographic remoteness of Alaska. The most effective intervention for promoting smoking cessation during pregnancy is financial incentives in which participants earn incentives (e.g., cash) contingent on objective evidence of smoking abstinence. This intervention has been adapted to be delivered entirely through a smartphone meaning that the geographic remoteness of Alaska will not be a barrier with this intervention. Participants submit videos of themselves completing breath and saliva tests, and incentives are then delivered through the application if the tests indicate smoking abstinence. Through a collaboration between the University of Vermont and the Alaska Native Tribal Health Consortium, the goal of this study is to examine the preliminary feasibility and efficacy of this smartphone-based incentives intervention among AN women. Pregnant AN women will be recruited through ads posted on social media. Eligible participants who complete the informed consent process will be randomized to either: Best Practices or Best Practices + Incentives. In the Best Practices condition, participants will receive three brief educational sessions and a referral to the Alaska state quitline. In the Best Practices + Incentives condition, participants will receive the same education sessions and quitline referral, plus financial incentives contingent on the smartphone-based testing of breath and saliva specimens indicating abstinence from recent smoking. Outcomes will include point prevalence smoking abstinence at assessments conducted in late pregnancy and 4-, 8-, 12-, and 24-weeks postpartum, continuous abstinence during antepartum and postpartum, and perceived barriers and facilitators of treatment engagement. Overall, this project has the potential to address disparities in access to efficacious, evidence-based smoking cessation treatments among AN pregnant women.
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
- 是
入选标准
- •≥ 18 years of age
- •report being smokers at the time they learned of the current pregnancy
- •report smoking in the 7 days prior to completing their preliminary eligibility screening
- •< 25 weeks pregnant
- •speak English
- •own a smartphone (Android or iOS)
- •self-report as an Alaska Native
- •current smoker as verified by saliva cotinine test
排除标准
- •current or prior mental or medical condition that may interfere with study participation
- •smoke marijuana more than once each week and not willing to quit (marijuana smoking can inflate breath CO)
- •exposed to unavoidable occupational sources of CO (e.g., car mechanic)
- •report currently receiving opioid maintenance therapy (e.g., methadone, buprenorphine)
结局指标
主要结局
Late Pregnancy Quit Rate
时间窗: 28 weeks gestation through date of delivery
Point prevalence smoking abstinence (defined as a cotinine-negative saliva test AND self-reported no smoking in the past seven days)
次要结局
- 8-Week Postpartum Quit Rate(8 weeks following the date that participants deliver their infant)
- 24-Week Postpartum Quit Rate(24 weeks following the date that participants deliver their infant)
- Longest Duration of Abstinence (LDA)(LDA will be measured from participant's date of enrollment in the study to 24-weeks postpartum)
- 12-Week Postpartum Quit Rate(12 weeks following the date that participants deliver their infant)
- Early Pregnancy Quit Rate(One month after participant's enrollment date)
- 4-Week Postpartum Quit Rate(4 weeks following the date that participants deliver their infant)
研究者
Diann Gaalema
Associate Professor of Psychiatry
University of Vermont
