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临床试验/NCT02438878
NCT02438878已完成不适用

Supporting Baby Behavior Through Pediatric Offices

University of California, Davis2 个研究点 分布在 1 个国家目标入组 423 人开始时间: 2015年3月最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
423
试验地点
2
主要终点
Weight-for-length growth trajectory

研究概览

简要总结

The primary objective of this project is to evaluate the impact on infant growth and infant-feeding practices of a low-cost series of video trainings and tools targeted to medical staff and designed to support ongoing Baby Behavior education of WIC participants.

详细描述

The primary objective of this project is to evaluate the impact on infant growth and infant-feeding practices of a low-cost series of video trainings and tools targeted to medical staff and designed to support ongoing Baby Behavior education of WIC participants. The intervention, currently used in all California WIC agencies, teaches caregivers to recognize and understand healthy infant behaviors such as the range of infant cues and common patterns for sleep and crying. This project will also evaluate the acceptance, knowledge transfer, and use of the tools by health care providers and medical staff. It is expected that trained staff will be prepared to share Baby Behavior messages with their patients and that the information will be delivered quickly and easily during well-baby visits.

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

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • 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

排除标准

  • 未提供

研究组 & 干预措施

Baby Behavior

Experimental

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.

干预措施: Baby Behavior (Behavioral)

Control

No Intervention

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.

结局指标

主要结局

Weight-for-length growth trajectory

时间窗: Up to 6 months postpartum

Weight-for-length Z scores calculated using the WHO Multicenter Growth Standards

次要结局

  • Maternal perceived stress(1 week, 2 months, and 6 months postpartum)
  • Infant feeding practices(1 week, 2 weeks, 2 months, 4 months, and 6 months postpartum)
  • Infant eating behavior(4 months postpartum)
  • Maternal self-efficacy(1 week, 2 months, and 6 months postpartum)
  • Infant sleep patterns(2 months and 6 months postpartum)
  • Maternal depressive symptoms(2 weeks and 6 months postpartum)
  • Infant development(2 months, 4 months, and 6 months postpartum)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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