ChoicesPlus: Preconception Approach to Reducing Alcohol- and Tobacco-Exposed Pregnancy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 261
- 试验地点
- 4
- 主要终点
- Risk of alcohol-exposed pregnancy
研究概览
简要总结
Choices Plus, a randomized controlled study, will determine the efficacy of the Project CHOICES intervention plus a referral to an evidence-based smoking cessation program in reducing the risk of alcohol- and tobacco-exposed pregnancies.
详细描述
This randomized controlled study will examine the effect of the ChoicesPlus intervention compared to Treatment as Usual (TAU) in: reducing alcohol use below established risk levels; increasing consistent use of effective contraception; increasing engagement in smoking cessation treatment and increasing smoking cessation. In addition, our examination of the incremental costs of the ChoicesPlus intervention (e.g., staff time, materials, administrative services, total medical charges pre- and post-intervention) will provide a basis for future cost/benefit analyses that will inform policymakers and healthcare organizations of the potential benefits of implementing ChoicesPlus. Results from this study will inform and advance future efforts in the service of promoting healthy prenatal behavior and reducing the prevalence of alcohol and tobacco-exposed pregnancies.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 44 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Have no condition causing infertility
- •Are not pregnant or planning to become pregnant in the next 9 months
- •Have had vaginal intercourse during the previous 3 months with a fertile man without using effective contraception
- •Are drinking at risk levels; and 5) are available for the follow-up period.
排除标准
- •Infertile
- •Insufficient locator information
- •Language other than English or Spanish
结局指标
主要结局
Risk of alcohol-exposed pregnancy
时间窗: 9 months
Timeline Followback
次要结局
- Marin Acculturation Scale, AUDIT, Time-Line Follow Back, University of Rhode Island Change Assessment Scale, Decisional Balance, Process of Change, Temptation, Confidence, Smoking Staging Algorithm, and Brief Symptom Inventory-18(9 months)