Examining a Digital Perinatal Smoking-Cessation Intervention
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 137
- 试验地点
- 1
- 主要终点
- Antepartum smoking abstinence
研究概览
简要总结
Cigarette smoking is the leading preventable cause of poor pregnancy outcomes in the U.S. and a problem for which more effective and easy-to-access treatments are much needed. This study examines whether outcomes achieved with recommended clinical practices (referral to state tobacco Quitline with follow-up and further referrals for those continuing to smoke) can be improved by also offering financial incentives delivered through a smartphone for maternal smoking abstinence.
详细描述
Pregnant women residing in the U.S. who currently smoke cigarettes and are interested in quitting will be recruited nationally and randomly assigned to what is considered clinical best practices (BP) (referral to state tobacco Quitline with follow-up and further referrals for those continuing to smoke) or best practices in combination with financial incentives (BP+FI). Women assigned to the BP+FI treatment will have opportunities to earn financial incentives by abstaining from smoking during pregnancy and for 3 months after delivering their baby (total possible incentives is $750.00). Women will demonstrate that they have abstained by taking brief salivary cotinine tests using a smartphone or equivalent device. Incentives for abstaining are electronically added to a study-provided debit card. Participation and all results are strictly confidential. Participants in both treatment conditions will be financially compensated for study participation with potential earnings of $525.00. Total potential earnings for those assigned to BP is $525.00 and for those assigned to BP+FI it is $1,275 ($525 for study participation and $750 in incentives for quitting smoking).
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 50 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •18 yrs of age
- •Reports current pregnancy of </= 25 weeks gestational age
- •Consents to allow us to confirm pregnancy with healthcare provider
- •Reports current smoking when learned of current pregnancy
- •Reports smoking in the 7 days prior to screening
- •Reports of smoking in past 7 days is confirmed by a salivary cotinine test
- •Owns a digital phone or tablet
- •Sufficiently fluent in English to complete study tasks
排除标准
- •Reports current or prior mental or medical condition that may interfere with study participation
- •Reports current opioid agonist treatment for opioid use disorder
- •Current use of prescribed opioid, antipsychotic, or stimulant medications
- •Live with someone who is enrolled in the study
- •Reside in a group home
- •Currently participating in another study that provides financial incentives
- •Legal problems that may result in incarceration within the next year
研究组 & 干预措施
Best Practices
Best Practices (BP) entails the 5As including referral to the state tobacco Quitline and further referral for those continuing to smoke.
干预措施: Best Practices (Behavioral)
Best Practices plus Financial Incentives
Best practices plus providing financial incentives contingent on biochemically verified abstinence. Incentives are in the form of vouchers exchangeable for retail items and available through 12-weeks postpartum.
干预措施: Best Practices (Behavioral)
Best Practices plus Financial Incentives
Best practices plus providing financial incentives contingent on biochemically verified abstinence. Incentives are in the form of vouchers exchangeable for retail items and available through 12-weeks postpartum.
干预措施: Financial Incentives (Behavioral)
结局指标
主要结局
Antepartum smoking abstinence
时间窗: Antepartum period is from study entry through infant delivery which is typically about 24 weeks duration.
The primary outcome is whether women randomly assigned to the two treatment groups differ in the percentage who abstain from smoking across an early (\< 25 weeks gestation) and late (\> 25 weeks gestation) antepartum assessments defined by the percentage of participants assigned to each condition who report no smoking in the past 7 days and submit of a salivary cotinine sample that tests negative for recent smoking.
次要结局
- Postpartum smoking abstinence(2-weeks, 6-weeks, 12-weeks following delivery.)
研究者
Stephen T. Higgins, PhD
University Distinguished Professor
University of Vermont