Owlet Band Observational Study: Observe the Use of a New Pregnancy Tracker for Expecting Mothers
试验速览
- 阶段
- 不适用
- 入组人数
- 8,000
- 试验地点
- 1
- 主要终点
- Gather information
研究概览
简要总结
This is an observational research study of a new pregnancy tracker used to gather information about a pregnant woman's general wellness.
详细描述
The Owlet Band is a wellness product (similar to a fitbit), it is not designed to be a "medical device". The study involves women age 18 and older who are currently pregnant, at least 24 weeks' gestation or later, and who live in the USA. Up to 8,000 pregnant women are expected to participate in the study. This study will involve review of Owlet Band data and participant responses to questionnaires throughout the study. The purpose of this research is to observe if using the new Owlet Band and the associated iPhone app can help pregnant women in managing their habits, anxiety, stress, enhancing bonding and attachment to their infant, while still maintaining their standard medical care.
研究设计
- 研究类型
- Observational
- 观察模型
- Ecologic Or Community
- 时间视角
- Prospective
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
- •Must be at least 24 weeks pregnant with a singleton pregnancy
- •Must be at least 18 years of age
- •Must currently live in the United States
- •Must have a compatible smartphone (Apple iOS Version 13 or above)
- •Able to read and understand English in order to provide Informed Consent and follow study instructions
排除标准
- 未提供
结局指标
主要结局
Gather information
时间窗: Up to 16 weeks
Completion of study questionnaires by at least 500 participants
次要结局
- Management of anxiety State Trait Anxiety Inventory(Participant completion of the STAI questionnaire before wearing the Owlet Band and at Day 31 (+3 days))
- Management of stress (Perceived Stress Scale)(Participant completion of the PSS questionnaire before wearing the Owlet Band and at Day 31 and Day 52 (+3 days))
- Participant's experience while using the Owlet Band(Through study completion, up to 16 weeks)
- Maintenance of standard medical care(Through study completion, up to 16 weeks)