Supporting Baby Behavior Through Pediatric Offices
研究概览
详细说明
研究类型
注册 (实际的)
阶段
- 不适用
联系人和位置
学习地点
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California
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Davis、California、美国、95616
- University of California, Davis
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- Will attend a participating pediatric clinic for her well-baby visits
- Primiparous, singleton pregnancy
- Currently enrolled in WIC
- At least 18 years of age
- Speaks and reads English or Spanish
- Has a telephone and access to the internet
- Plans to stay in the area for 6 months after birth of infant
- Abstained from smoking during pregnancy
Exclusion criteria:
- Gave birth before 37 weeks gestation
- She and/or her infant has health condition(s) or known health risks that contraindicate breastfeeding
- She and/or her infant has health condition(s) or known health risks that impact infant growth and development
学习计划
研究是如何设计的？
设计细节
- 主要用途：预防
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的：Baby Behavior
The intervention is comprised of 2 components: HCP and medical staff training and participant education. The trainings will be video-based and aim to build providers' knowledge and skills to support parents' recognition and understanding of common healthy infant behaviors that may be misinterpreted by parents. The intervention does not include any specific recommendations for infant feeding, nor does it include any information related to the assessment, diagnosis or treatment for any medical condition. After completion of the intervention trainings, health care providers and medical staff will be asked to use what they learned with the mothers of infants in their care. Short handouts for mothers will be provided as tools to reinforce the verbal education. All educational materials will be focused only on supporting parents' abilities to recognize and understand common, healthy infant behaviors. |
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无干预：Control
The control arm will continue with standard well-baby visit practices during the intervention period and will be offered the option to complete the Baby Behavior online trainings for continuing education credits.
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Weight-for-length growth trajectory
大体时间：Up to 6 months postpartum
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Weight-for-length Z scores calculated using the WHO Multicenter Growth Standards
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Up to 6 months postpartum
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Infant feeding practices
大体时间：1 week, 2 weeks, 2 months, 4 months, and 6 months postpartum
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Breastfeeding duration and exclusivity, introduction of non-breast milk foods and fluids, use of sugary beverages, and intake of formula and select complementary foods
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1 week, 2 weeks, 2 months, 4 months, and 6 months postpartum
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Maternal depressive symptoms
大体时间：2 weeks and 6 months postpartum
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Edinburgh Postnatal Depression Scale
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2 weeks and 6 months postpartum
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Maternal self-efficacy
大体时间：1 week, 2 months, and 6 months postpartum
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Perceived Maternal Parenting Self-Efficacy
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1 week, 2 months, and 6 months postpartum
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Maternal perceived stress
大体时间：1 week, 2 months, and 6 months postpartum
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Perceived Stress Scale Short-Form
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1 week, 2 months, and 6 months postpartum
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Infant sleep patterns
大体时间：2 months and 6 months postpartum
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Brief Infant Sleep Questionnaire
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2 months and 6 months postpartum
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Infant development
大体时间：2 months, 4 months, and 6 months postpartum
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Ages and Stages Questionnaire
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2 months, 4 months, and 6 months postpartum
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Infant eating behavior
大体时间：4 months postpartum
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Baby Eating Behavior Questionnaire
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4 months postpartum
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合作者和调查者
调查人员
- 首席研究员：Jane Heinig, PhD、University of California, Davis
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.