跳至主要内容
临床试验/NCT06058871
NCT06058871进行中(未招募)不适用

Ecological Momentary Breastfeeding Intervention to Improve Breastfeeding Outcomes: a Randomized Controlled Trial

The University of Hong Kong2 个研究点 分布在 1 个国家目标入组 518 人开始时间: 2024年4月22日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
518
试验地点
2
主要终点
Overall duration of any breastfeeding in each study groups

研究概览

简要总结

During Chinese mothers' doing the month, they are often housebound and find it difficult to attend group support or seek help during the first month postpartum which is the critical period in sustaining exclusive breastfeeding and at high risk of weaning. This can adversely affect their general well-being, and are associated with stress, anxiety and postnatal depression. Thus, mothers have expressed the need for real-time, real world, personalized support that allow them to get immediate breastfeeding support, helps in overcoming the challenges and subsequently improve exclusive breastfeeding. The aim of the proposed study is to assess the effectiveness of an ecological momentary intervention (EMI)-based breastfeeding intervention in improving exclusive breastfeeding outcomes and to inform clinical practice and services for breastfeeding mothers in Hong Kong. Such interventions have been considered as a rising shift from traditional model of care towards an e-technology based health model that may improve exclusive breastfeeding duration globally.

详细描述

It is well recognised that breastfeeding is extremely beneficial for child survival, growth, and maternal health and is one of the most effective health interventions for preventing infant and child mortality and promoting lifelong maternal health. In addition, breastfeeding provides significant economic benefits and improves health equity in society. In Hong Kong, data from 2021 shows only 22% of women exclusively breastfeed until six months postpartum, significantly less than both the average global rate of 38% and the World Health Organization (WHO) 2025 target of 50%. Some of the common reasons cited by mothers for early weaning relate to breastfeeding problems that are easily avoided with appropriate early professional support, such as perceived insufficient milk, poor latching and sore breasts. Timely breastfeeding support could therefore promote exclusive breastfeeding. However, such support is often inadequate and has been difficult to obtain during the recent COVID-19 pandemic. In addition, mothers in Hong Kong may find it difficult to leave home during the early postpartum period due to the overwhelming workload and the cultural tradition practice of 'doing the month' in which women remain housebound during the first month postpartum. Therefore, it is be important to provide adequate support to mothers in Hong Kong to ensure that breastfeeding can continue for the optimal duration, thereby providing life-long protection for both mother and infant.

Social cognitive theory (SCT) is widely used to analyse behavioural changes in breastfeeding in response to technology-guided interventions. The investigators will use SCT as a theoretical framework to guide the development of a message library and the delivery of both regular and chat-style support messages. The increased accessibility of an Internet-delivered intervention provides a way to promote each mother's sense of agency by enabling them to access the support they require when they need it. As more people turn to eHealth, the development of an Internet-delivered SCT-based intervention (iSCT-I) to support and educate women may provide a cost-effective way to increase breastfeeding rates. Moreover, the WHO has concluded that will not be possible to reach universal health care coverage without investing in, and broadly adopting, eHealth. EMI is a cost-effective intervention framework that allows personalisation of both the content and delivery method, it can therefore provide a practical and effective strategy for delivering iSCT-I for improving breastfeeding duration and uptake. However, there have been no previous studies of EMI-based breastfeeding interventions. Therefore, the investigators propose an RCT to evaluate the effectiveness of EMI-delivered iSCT-I; a real-time, personalized, and cost-effective approach for improving exclusive breastfeeding rates.

This multi-center randomized control trial adopts two arm design to examine and compare the effects between ecological momentary intervention and usual care to improve breastfeeding outcomes. The study hypotheses are (1) Primiparous mothers who receive an EMI-based breastfeeding intervention will significantly increase their exclusive breastfeeding intention and duration, and (2) The intervention group will have a higher breastfeeding self-efficacy score (BSES) and breastfeeding knowledge and attitude scores at three months postpartum.

A pilot study will be conducted. Aiming to recruit 20 participants. (10:Intervention; 10 Control)

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)

入排标准

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

入选标准

  • •be primiparous mothers
  • •have had a singleton pregnancy and live birth
  • •have birthed a full-term infant (37-42 weeks gestation)
  • •speak Cantonese
  • •be a Hong Kong resident
  • •have no serious medical or obstetrical complications and have not had their infant admitted to the neonatal intensive care unit (NICU)

排除标准

  • •is < 37 weeks gestation
  • •has an Apgar score < 8 at five minutes
  • •has a birthweight < 2500 grams
  • •is born with any severe medical conditions or congenital malformations
  • •is placed in the special care nursery for more than 48 hours after delivery
  • •is placed in the intensive care nursery after delivery

研究组 & 干预措施

EMI intervention group

Experimental

Participants in the intervention group will receive instant messaging (i.e., an EMI delivery platform). Our multidisciplinary team, including an obstetrician, midwife, lactation consultant, biostatistician, and social psychologist, will develop a message library and protocol for EMI delivery.

干预措施: Nurse-led real-time support messages (chat type) (Behavioral)

EMI intervention group

Experimental

Participants in the intervention group will receive instant messaging (i.e., an EMI delivery platform). Our multidisciplinary team, including an obstetrician, midwife, lactation consultant, biostatistician, and social psychologist, will develop a message library and protocol for EMI delivery.

干预措施: Regular messages (Behavioral)

Control group

No Intervention

Participants in the control group will receive text messages containing general information on breastfeeding from the Hospital Authority, which is open to the public and includes reminder text messages of important follow-up surveys. Messages will not be personalised, and nurse-led real-time support messages will not be available.

结局指标

主要结局

Overall duration of any breastfeeding in each study groups

时间窗: At 1, 2, 3 and 6 months postpartum

The number of participants who are any breastfeeding at each time point.

Proportion of participants in each study groups exclusively breastfeeding

时间窗: At 1, 2, 3 and 6 months postpartum

The number of participants who are exclusively breastfeeding at each time point.

次要结局

  • Breastfeeding self-efficacy scores between the two study groups(baseline and 1 and 3 months postpartum)
  • Infant feeding knowledge and attitude scores between the two study groups(baseline and 1 and 3 months postpartum)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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