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临床试验/NCT04621266
NCT04621266
已完成
不适用

Effectiveness of a Home-based Peer Support Program for Chinese Mothers With Low Breastfeeding Self-efficacy to Increase the Exclusivity and Duration of Breastfeeding: a Randomized Controlled Trial

The University of Hong Kong2 个研究点 分布在 1 个国家目标入组 442 人2021年8月13日

概览

阶段
不适用
干预措施
Online Home-based peer support
疾病 / 适应症
Breastfeeding
发起方
The University of Hong Kong
入组人数
442
试验地点
2
主要终点
Infant Feeding Status: Exclusive Breastfeeding
状态
已完成
最后更新
2个月前

概览

简要总结

An online home-based breastfeeding peer support programme is proposed to support mothers who are giving birth to their first-born. This study aims to evaluate the effectiveness of this programme in improving breastfeeding practices among women with low breastfeeding self-efficacy. It is hypothesized that participants who received online home-based peer support will exclusively breastfeed for longer duration, have higher breastfeeding self-efficacy, and lower post-partum depression symptoms when compared to those receiving only standard care.

详细描述

Primiparous mothers who plan to breastfeed but did not go on to breastfeed often face high levels of emotional and psychological challenges in their transition to parenthood. This can adversely affect their breastfeeding experiences and general well-being, and is associated with stress, anxiety, and postnatal depression. While family psycho-education and other supportive group programmes are available in health services, they require face-to-face education sessions over a long interval, high engagement, and trusting relationships, and thus often result in low attendance and high drop outs. Mothers have expressed the need for psychological support of peer counsellors, which would allow them to support each other. The first month postpartum is a critical period for sustaining exclusive breastfeeding and the time when mothers are at high risk of postpartum depression. For Chinese mothers in Hong Kong, however, they are often housebound during this period due to the tradition of "doing the month", and thus often find it difficult to attend support groups or seek help. In view of these challenges and the pandemic wave faced by primiparous mothers, they are reluctant with home visits, therefore an online delivery of the home-based peer support programme is proposed. This randomized control trial adopts a two-arm design to examine the effectiveness of an online home-based peer support programme for women with low breastfeeding self-efficacy. It is hypothesized that those receiving the intervention, when compared to the controls, will have (1) longer period of exclusive breastfeeding, (2) higher postnatal breastfeeding self-efficacy, and (3) lower post-partum depressive symptoms.

注册库
clinicaltrials.gov
开始日期
2021年8月13日
结束日期
2024年1月18日
最后更新
2个月前
研究类型
Interventional
研究设计
Parallel
性别
Female

研究者

责任方
Sponsor

入排标准

入选标准

  • Primiparous mothers
  • Intend to breastfeed
  • Have low breastfeeding self-efficacy (between 14 to 32)
  • Have singleton pregnancy and live birth
  • Have term infant (37-42 weeks gestational)
  • Cantonese speaking
  • Hong Kong resident
  • Have no serious medical or obstetrical complications

排除标准

  • Infant is \<37 week gestation
  • Infant has Apgar score \<8 at five minutes
  • Infant has birthweight \<2,500 grams
  • Infant has any severe medical conditions or congenital malformations
  • Infant is placed in the special care baby unit for more than 48 hours after birth
  • Infant is placed in the neonatal intensive care unit at any time after birth

研究组 & 干预措施

Online Home-based peer support intervention

Participants will receive intervention on top of standard usual care.

干预措施: Online Home-based peer support

Standard usual care

Participants will receive standard usual care.

结局指标

主要结局

Infant Feeding Status: Exclusive Breastfeeding

时间窗: At 6 months postpartum

Number/ proportion of participants that practice exclusive breastfeeding at 6 months postpartum.

Infant Feeding Status: Exclusive Breastfeeding

时间窗: At 1 month postpartum

Number/ proportion of participants who practice exclusive breastfeeding at 1 months postpartum.

Infant Feeding Status: Exclusive Breastfeeding

时间窗: At 2 months postpartum

Number/ proportion of participants who practiced exclusive breastfeeding at 2 month postpartum.

Infant Feeding Status: Exclusive Breastfeeding

时间窗: At 4 months postpartum

Number/ proportion of participants that practice exclusive breastfeeding at 4 months postpartum.

次要结局

  • Women's Self-efficacy in Breastfeeding(At baseline, 2 months and 4 months postpartum)
  • Women's Self-efficacy in Breastfeeding at Baseline(At baseline)
  • Women's Self-efficacy in Breastfeeding at 2 Months Postpartum(At 2 months postpartum)
  • Women's Self-efficacy in Breastfeeding at 4 Months Postpartum(At 4 months postpartum)
  • Women's Postpartum Depression at Baseline(At baseline)
  • Women's Postpartum Depression at 1 Month Postpartum(At 1 month postpartum)
  • Women's Postpartum Depression at 2 Month Postpartum(At 2 month postpartum)

研究点 (2)

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