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临床试验/NCT05109988
NCT05109988已完成不适用

The Effect of a Father-involvement Breastfeeding Telephone Support Intervention on Exclusive and Sustained Breastfeeding: A Randomized Controlled Trial.

The Hong Kong Polytechnic University1 个研究点 分布在 1 个国家目标入组 649 人开始时间: 2022年4月18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
649
试验地点
1
主要终点
Prevalence of exclusive breastfeeding

研究概览

简要总结

The World Health Organization advocates for breastfeeding as the best source of food for optimal infant development, which reduces the risk of infant mortality and morbidity. The objectives of this study are to evaluate the effect of a father-involvement breastfeeding telephone support intervention on prevalence and duration of exclusive breastfeeding, postnatal depression and parent-infant bonding. The intervention consists of four weekly 20-30 minutes telephone-administered counselling sessions on breastfeeding, delivered individually in the first month postpartum for mothers and fathers. We expect that women who receive the intervention will have a higher rate and longer duration of exclusive breastfeeding, fewer depressive symptoms and better parent-child relationship. The knowledge gained from this study can provide direction for the development of flexible, accessible and culturally sensitive interventions to promote breastfeeding and mental health in Chinese society.

详细描述

Exclusive breastfeeding is recommended as the most beneficial form of infant nutrition during the first 6 months of life, which protects infants against childhood illness and reduces the risk of infant mortality and morbidity. The aim of this study is to implement and evaluate a breastfeeding telephone support intervention that involves mothers and fathers during the postpartum period. The objectives are to evaluate the effect of a father-involvement breastfeeding telephone support intervention on prevalence and duration of exclusive breastfeeding, postnatal depression and parent-infant bonding.

Hypothesis to be tested:

  1. Mothers who receive the father-involvement telephone support intervention will have a higher rate and a longer duration of exclusive breastfeeding at 1, 2, 4 and 6 months postpartum than those who receive the standard postpartum care.
  2. Mothers and fathers who receive the intervention will have: (a) fewer depressive symptoms, and (b) better parent-infant bonding at 2 and 6 months postpartum than those who receive the standard postpartum care.

Design and subjects: Randomized controlled trial. A sample of postpartum mothers (n = 738) and fathers (n = 738) will be randomly assigned to either the experimental or the control groups.

Study instruments: Edinburgh Postnatal Depression Scale (EPDS) and Postpartum Bonding Questionnaire (PBQ).

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
Single (Outcomes Assessor)

盲法说明

The outcome measures will be collected by a research assistant who is blind to the group allocation.

入排标准

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

入选标准

  • •aged 18 years or above;
  • •giving birth to a single healthy baby at term
  • •ability to speak and read the Chinese language

排除标准

  • •psychiatric illness

研究组 & 干预措施

Intervention

Experimental

The intervention consists of four weekly 20-30 minutes telephone-administered counselling sessions on breastfeeding, delivered individually in the first month postpartum for mothers and fathers.

干预措施: Breastfeeding telephone support (Behavioral)

Control

No Intervention

Standard postpartum care

结局指标

主要结局

Prevalence of exclusive breastfeeding

时间窗: 1 month

The prevalence/proportion of infants younger than 1 month who are exclusively breastfed is calculated as the number of infants younger than 1 month who are exclusively breastfed in the last 24 hours divided by the total number of infants younger than 1 month.

次要结局

  • Postpartum Bonding Questionnaire(6 months)
  • Prevalence of exclusive breastfeeding(6 months)
  • Duration of exclusive breastfeeding(6 months)
  • Edinburgh Postnatal Depression Scale(6 months)
  • Prevalence of exclusive breastfeeding(2 months)
  • Postpartum Bonding Questionnaire(2 months)
  • Prevalence of exclusive breastfeeding(4 months)
  • Duration of exclusive breastfeeding(1 month)
  • Duration of exclusive breastfeeding(2 months)
  • Duration of exclusive breastfeeding(4 months)
  • Edinburgh Postnatal Depression Scale(2 months)

研究者

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

Ngai Fei Wan

Assistant Professor

The Hong Kong Polytechnic University

研究点 (1)

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