The Baby Care Study: Online Support for New Parents
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 74
- 试验地点
- 2
- 主要终点
- Number of infant night wakings
研究概览
简要总结
The objective of this study is to provide pilot data on the feasibility and effectiveness of a web-based social networking intervention designed to promote sleep early in infancy and to explore the potential for this approach to promote healthy feeding routines, eating behaviors, and weight outcomes in subsequent larger-scale intervention research. First-time parents will be recruited (n=66) and randomized to an 8-week web-based social networking sleep intervention or general baby care control group with interventions beginning at infant age 8 weeks. Parents will complete online surveys, with research questions including: 1) whether the sleep intervention leads to longer nighttime and total sleep duration and decreased night waking among infants and 2) longer infant sleep bouts and improved parent sleep duration, stress, parenting efficacy, and parenting satisfaction. We will also examine infants' routines, feeding and eating behaviors, and emotion regulation to inform the application of this approach for childhood obesity prevention. The pilot research will provide insights into intervention feasibility, effects on infant sleep, and potential impacts on feeding and eating outcomes, informing our next steps.
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
- None
盲法说明
Participants are randomly assigned to one of two online, behavioral interventions. Because the participants will know which behaviors are promoted to their group, and study staff will be interacting with the participants in their groups, masking is not possible. However, which group is considered the main intervention versus the attention control will not be known to participants.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •English-speaking, first-time parents/legal guardians >18 years of a young infant who is < 6 weeks at the time of recruitment (or pregnant first-time parents expecting an infant soon). We will not include any parents who report that they do not have access to or an interest in using a private group on social media and/or online surveys.
排除标准
- •We will exclude families not meeting age criteria, as well as any parents who report that they do not have access to or an interest in using a private group on social media and/or online surveys. We will also exclude parents of infants who are born premature (prior to 37 weeks gestational age) and parents of multiples (twins, triplets, etc.).
结局指标
主要结局
Number of infant night wakings
时间窗: From baseline (infant age 6 weeks) to follow-up (age 7 months)
Number of night wakings for the infant, from the Brief Infant Sleep Questionnaire (Sadeh)
Nighttime infant sleep duration
时间窗: From baseline (infant age 6 weeks) to follow-up (age 7 months)
Total hours of nighttime sleep for the infant, from the Brief Infant Sleep Questionnaire (Sadeh)
Total infant sleep duration
时间窗: From baseline (infant age 6 weeks) to follow-up (age 7 months)
Total hours of sleep for the infant, from the Brief Infant Sleep Questionnaire (Sadeh)
次要结局
- Parenting satisfaction(From baseline (infant age 6 weeks) to follow-up (age 7 months))
- Infant's longest sleep bout(From baseline (infant age 6 weeks) to follow-up (age 7 months))
- Parent sleep duration(From baseline (infant age 6 weeks) to follow-up (age 7 months))
- Parent stress(From baseline (infant age 6 weeks) to follow-up (age 7 months))
- Parenting self-efficacy(From baseline (infant age 6 weeks) to follow-up (age 7 months))
研究者
Stephanie Anzman-Frasca
Associate Professor of Pediatrics
State University of New York at Buffalo