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临床试验/NCT03533725
NCT03533725已完成不适用

Breastfeeding Education Support Tool for Baby

Thomas Jefferson University1 个研究点 分布在 1 个国家目标入组 247 人开始时间: 2019年3月11日最近更新:
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
247
试验地点
1
主要终点
Breastfeeding initiation soon after birth

研究概览

简要总结

This study will compare data associated with breastfeeding experiences and outcomes--specifically, breastfeeding continuation after initiation, exclusivity for 6 months of an infant's life, and breastfeeding duration--among 120 subjects recruited late in pregnancy and provided peer counseling and education services incorporating mobile health (mHealth) tools during a period of at least 6 months post-delivery with the data collected from a control group of approximately 120 mothers that did not receive the study intervention.

详细描述

Approximately 24 women that are experienced in breastfeeding will be recruited to serve in the role of breastfeeding peer counselors. These women will assess usability and acceptability of mobile health (mHealth) education tools designed following a series of focus groups for the project, Breastfeeding Education Support Tool for Baby. The mHealth tools will be used during the training and education of the peer counselor subjects. Following appropriate modification, some of the mHealth tools will be used with a total of approximately 120 women recruited late in pregnancy for initial breastfeeding counseling before delivery and the subsequent provision, for at least 6 months post-delivery, of home visits for peer counseling and education that integrates use of mHealth tools. Peer counselors and research staff will gather data from mothers receiving the intervention about breastfeeding experiences and outcomes, including breastfeeding continuation after initiation, exclusivity for 6 months of an infant's life, and breastfeeding duration. This data will be compared to data obtained through surveys administered to a control group of approximately 120 maternal subjects that received standard pre- and post-delivery care but not the study intervention of peer counseling and education using mHealth tools.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Health Services Research
盲法
None

入排标准

年龄范围
18 Years 至 50 Years(Adult)
性别
Female
接受健康志愿者
是

入选标准

  • •A. Peer counselors
  • •Inclusion Criteria:
  • •Personal experience with breastfeeding - Residence in an intervention cluster

排除标准

  • •Failing to participate in peer counselor education/training provided for the study
  • •B. Intervention Pregnant women-mothers
  • •Inclusion Criteria:
  • •Willingness to consent to assignment to a breastfeeding peer counselor and to participate in counseling and education visits
  • •Residence in an intervention cluster and intent to remain in the intervention area for a minimum of 6 months post-delivery
  • •Exclusion Criteria:
  • •Pregnant women-mothers that indicate before delivery that they will not initiate breastfeeding
  • •C. Control Subjects
  • •Inclusion Criteria:
  • •Mothers delivering during the study period that live in a non-intervention area that has been designated for recruitment of control subjects
  • •Willingness to participate in a survey enabling collection of data for comparative purposes
  • •Exclusion Criteria:

研究组 & 干预措施

Intervention group

Experimental

Breastfeeding counseling and education services using mHealth tools

干预措施: Breastfeeding counseling and education services (Other)

Comparative control group

No Intervention

No intervention, only standard of care

结局指标

主要结局

Breastfeeding initiation soon after birth

时间窗: Ideally within an hour following a normal delivery

Maternal subjects' compliance with the recommendation to initiate breastfeeding soon after delivery

Exclusivity of breastfeeding during the first 6 months following an infant's birth

时间窗: First 6 months following an infant's birth

Maternal subjects' compliance with the recommendation to provide only breast milk

Breastfeeding continuation (along with supplemental feeding) after an infant reaches 6 months of age

时间窗: As the study is time-limited, assessment will occur 6-9 months following an infant's birth

Maternal subjects' compliance with the recommendation for continued breastfeeding along with supplemental feeding after an infant reaches 6 months of age

次要结局

  • Usability rating of the mHealth tools by peer counselors post-training(At the end of counseling education/training (project months 8-9))
  • Usability rating of the mHealth tools by peer counselors based on use with mothers(Once peer counselors complete delivery of services to assigned maternal subjects (by months 22-23 of the project))
  • Acceptability rating of BEST4Baby program features by mothers(3 months post-delivery)
  • Satisfaction rating of mothers with BEST4Baby counseling and education services as delivered(6-9 months post-delivery)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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