跳至主要内容
临床试验/NCT03589963
NCT03589963终止不适用

Effectiveness and Feasibility of Providing Postnatal Breastfeeding Support to Vulnerable Mothers as an Extension to the Canada Prenatal Nutrition Program

University of Toronto2 个研究点 分布在 1 个国家目标入组 151 人开始时间: 2018年11月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
终止
入组人数
151
试验地点
2
主要终点
Exclusive breastfeeding at 4 months postpartum

研究概览

简要总结

The Canada Prenatal Nutrition Program (CPNP) aims to improve birth outcomes among Canadian women in challenging life circumstances, including those who are adolescents, newcomers, low-income or single mothers. The CPNP strongly promotes breastfeeding prenatally, resulting in high initiation rates, but continued postnatal support is needed to optimize breastfeeding duration and exclusivity.

The aim of this research is to investigate the effects of adding postnatal lactation support as an extension to the CPNP on breastfeeding duration and exclusivity in the first six months postpartum. The research will be conducted at two CPNP sites in Toronto, Parkdale Queen West Community Health Centre and The Stop Community Food Centre. A quasi-experimental design will be used to compare the infant feeding practices of CPNP clients before and after introduction of a postnatal lactation support intervention which will include in-home professional lactation support and provision of high-quality breast pumps. These services will be delivered as CPNP program components and will be accessible to all clients at the two participating sites during the post-intervention period. Infant feeding practices will be assessed by a questionnaire administered at 2 weeks, 1, 2, 3, 4, 5 and 6 months postpartum. The hypothesis is that significantly more mothers in the post-intervention group will be exclusively breastfeeding at four months postpartum. The effect is expected to be mediated through increased breastfeeding self-efficacy, which will be assessed using validated scales prenatally and at 2 weeks and 2 months postpartum.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Sequential
主要目的
Prevention
盲法
None

入排标准

年龄范围
15 Years 至 49 Years(Child, Adult)
性别
Female
接受健康志愿者
是

入选标准

  • •CPNP clients registered prenatally
  • •intention to initiate breastfeeding
  • •intention to remain in Toronto with the infant for 6 months postpartum
  • •willing to share contact information
  • •birth at 34 weeks gestation or later

排除标准

  • •preterm birth (below 34 weeks)
  • •infant has congenital abnormality or medical condition affecting feeding
  • •mother or infant still in hospital at 2 weeks postpartum

研究组 & 干预措施

Pre-intervention

No Intervention

regular CPNP programming

Post-intervention

Experimental

regular CPNP programming plus access to postnatal lactation support

干预措施: Postnatal Lactation Support (Behavioral)

结局指标

主要结局

Exclusive breastfeeding at 4 months postpartum

时间窗: birth to 4 months postpartum

Reported exclusive breastfeeding at four months postpartum assessed by a prospective infant feeding questionnaire

次要结局

  • Age of introduction of breastmilk substitutes(birth to 6 months postpartum)
  • Age of introduction of complementary foods(birth to 6 months postpartum)
  • Duration of any breastfeeding in the first six months postpartum(birth to 6 months postpartum)
  • Duration of exclusive breastfeeding in the first six months postpartum(birth to 6 months postpartum)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Daniel Sellen

Professor

University of Toronto

研究点 (2)

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