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A WeChat-based Intervention to Support Breastfeeding

2020年8月3日 更新者:Li Tang、Chengdu Jinjiang Maternity and Child Health Hospital

A WeChat-based Intervention to Promote and Support Breastfeeding in China: A Multi-center Randomized Controlled Trial

The aim of the randomized controlled trial (RCT) is to evaluate the effects of an intervention program delivered via WeChat platform to support exclusive breastfeeding in China. WeChat, a free smart phone application, is the most popular social networking platform in China. It will be used to deliver health educational messages to the study participants. Our hypothesis is that the intervention program can lead to at least a 10% increase in exclusive breastfeeding prevalence at 6 months when compared to the control group.

A multicenter RCT of 1,000 participants will be conducted at four maternity hospitals in Chengdu, China. Eligible pregnant women who consent to participate will be recruited from the antenatal clinic at around 30 weeks of gestation and will be randomly assigned to either the intervention or control group on a 1:1 ratio.

After randomization, all participants will be asked to scan a Quick Response code to follow our WeChat public account, which can send push notifications to alert participants for new content, topics, links to a searchable library and frequently asked questions and answers. From baseline until childbirth, control group participants will receive non-breastfeeding related messages, such as healthy lifestyle and nutrition during pregnancy, from WeChat, whereas the intervention group participants will receive breastfeeding related messages, including preparation for breastfeeding after birth and the health benefits of breastfeeding, from WeChat. After childbirth, intervention group mothers will continue to receive information about breastfeeding for 6 months. The investigators will use WeChat to remind mothers about the importance of exclusive breastfeeding, build confidence and motivate them to continue exclusive breastfeeding. Meanwhile, the control group participants will receive information on other topics of interest to mothers, such as immunization, safety, infant growth, and etc.

Each participant will be interviewed in person by trained nurses at baseline, at discharge and be interviewed by telephone using structured questionnaires at 1, 4, and 6 months postpartum to collect detailed information on breastfeeding practices. All participants receive normal prenatal and postpartum maternity services. Cox proportional hazard models and multilevel mixed regression models will be performed respectively to compare the duration of exclusive breastfeeding and the rates of exclusive breastfeeding within six months postpartum between intervention and control groups.

研究概览

研究类型

介入性

注册 (预期的)

1000

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习联系方式

学习地点

      • Chengdu、中国
        • 招聘中
        • Chengdu Qingyang Maternal and Child Health Hospital
        • 接触:
          • Xu Yan

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 及以上 (成人、年长者)

接受健康志愿者

有资格学习的性别

女性

描述

Inclusion Criteria:

  • own a smart phone;
  • 18 years or above;
  • sufficient language skills (completed secondary school education);
  • carry a singleton fetus;
  • at a gestational age of 28 to 30 weeks;

Exclusion Criteria:

  • have existing medical conditions or pregnancy complications which may inhibit breastfeeding initiation, according to their medical doctor;
  • intend to give birth in health institutes other than the study hospitals.

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 主要用途:卫生服务研究
  • 分配:随机化
  • 介入模型:并行分配
  • 屏蔽:三倍

武器和干预

参与者组/臂
干预/治疗
实验性的:Intervention group
Participants receive breastfeeding-related information from WeChat
Participants in the intervention group will be asked to follow our WeChat public account immoderately after randomization. They will receive breastfeeding related messages three times a week from WeChat, including preparation for breastfeeding after birth and the health benefits of breastfeeding, from baseline until childbirth. After childbirth, intervention group mothers will continue to receive information, which is mainly about breastfeeding, once a week for 6 months. WeChat will send push notifications to remind mothers about the importance of exclusive breastfeeding, build confidence and motivate them to continue exclusive breastfeeding.
有源比较器:Control group
Participants receive non-breastfeeding information from WeChat
Participants in the control group will be asked to follow our WeChat public account immoderately after randomization. They will receive messages mainly on topics of healthy lifestyle and nutrition during pregnancy, from baseline until childbirth. After childbirth, they will continue to receive information on other topics of interest to mothers, such as immunization, safety, infant growth, and etc., until 6 months postpartum.

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Exclusive breastfeeding rate at 6 months postpartum
大体时间:6 months postpartum
Breastfeeding while giving no other food or liquid, not even water, with the exception of drops or syrups consisting of vitamins, mineral supplements or medicines.
6 months postpartum
Full breastfeeding rate at 6 months postpartum
大体时间:6 months postpartum
Infants who are receiving almost all of their nutrients from breast milk but take some other liquids such as water, water-based drinks, oral rehydration solutions, ritual fluids, and drops or syrups.
6 months postpartum

次要结果测量

结果测量
措施说明
大体时间
Infant's first feed
大体时间:0-7 days postpartum
% of infants fed with breastmilk as their first feed
0-7 days postpartum
Exclusive breastfeeding duration to 4 months postpartum
大体时间:0-4 months postpartum
Breastfeeding while giving no other food or liquid, not even water, with the exception of drops or syrups consisting of vitamins, mineral supplements or medicines.
0-4 months postpartum
Exclusive breastfeeding duration to 6 months postpartum
大体时间:0-6 months postpartum
Breastfeeding while giving no other food or liquid, not even water, with the exception of drops or syrups consisting of vitamins, mineral supplements or medicines.
0-6 months postpartum
Rate of early introduction of complementary feeding
大体时间:0-4 months postpartum
Complementary feeding is defined as feeding infants with solid foods and liquids other than breastmilk or infant formula.
0-4 months postpartum
Any breastfeeding duration to 6 months postpartum
大体时间:0-6 months postpartum
The child has received breastmilk (direct from the breast or expressed) with or without other drink, formula or other infant food
0-6 months postpartum

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2020年6月28日

初级完成 (预期的)

2021年12月31日

研究完成 (预期的)

2022年12月31日

研究注册日期

首次提交

2020年7月28日

首先提交符合 QC 标准的

2020年8月3日

首次发布 (实际的)

2020年8月5日

研究记录更新

最后更新发布 (实际的)

2020年8月5日

上次提交的符合 QC 标准的更新

2020年8月3日

最后验证

2020年8月1日

更多信息

与本研究相关的术语

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

药物和器械信息、研究文件

研究美国 FDA 监管的药品

研究美国 FDA 监管的设备产品

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