Effect of breastfeeding education and support intervention (BFESI) versus routine care on timely initiation and exclusive breastfeeding in Southwest Ethiopia: study protocol for a cluster randomized controlled trial
Effect of breastfeeding education and support intervention (BFESI) versus routine care on timely initiation and exclusive breastfeeding in Southwest Ethiopia: study protocol for a cluster randomized controlled trial
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DOI：
10.1186/s12887-018-1278-5
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发表时间：
2018-09-26
期刊：
影响因子：
2.4
通讯作者：
Magnus, Jeanette H.
中科院分区：
文献类型：
--
作者：
Abdulahi, Misra;Fretheim, Atle;Magnus, Jeanette H.
背景：埃塞俄比亚的婴儿死亡率仍然很高。母乳喂养被认为是降低婴儿死亡率的最简单和最便宜的战略。产前和产后提供的以社区为基础的教育和支助干预措施对提高母乳喂养率是有效的。然而，这种干预措施在埃塞俄比亚没有得到广泛实施。本研究旨在评估母乳喂养教育和支持对及时启动和持续时间的纯母乳喂养的影响。方法：在社区水平进行一项整群随机对照试验，比较母乳喂养教育和支持与常规护理的效果。干预措施将由已经进入该国卫生系统的妇女发展军领导人提供，他们使用40小时的世卫组织母乳喂养咨询课程、"婴幼儿喂养咨询：综合课程"和当地语言的"孕产妇、婴幼儿和幼儿营养咨询培训员培训手册"。将为他们制定文化上适当的业务信息包。根据预先设定的标准，将从36个区招募至少432名妊娠晚期的孕妇。干预组的访视包括两次产前访视和8次产后访视。每月将对每个干预区进行监督访问。将数据输入Epi-data版本3.1，并使用STATA版本13.0进行分析。所有分析将通过意向治疗分析进行。我们将为连续结局拟合混合效应线性回归模型，为二元结局拟合混合效应线性概率模型，以研究区域作为随机截距，以估计根据结局基线值和其他相关协变量调整的研究组差异（干预vs.常规教育）。该协议是与Jimma区和Mana区卫生办公室合作制定的。从奥斯陆大学和吉玛大学的机构审查委员会获得伦理批准。这项研究是由NORAD的NORHED programme. Discussion部分资助：我们预计，试验将产生的结果，可以告知母乳喂养的政策和做法在埃塞俄比亚。
Background: Infant mortality rates are still high in Ethiopia. Breastfeeding is regarded as the simplest and least expensive strategy for reduction of infant mortality rates. Community-based educational and support interventions provided prenatally and postnatally are effective in increasing breastfeeding rates. However, such interventions are not widely implemented in Ethiopia. This study aims to assess the effect of breastfeeding education and support on timely initiation and duration of exclusive breastfeeding.Methods: A cluster-randomized controlled trial at the community level will be conducted to compare the effect of breastfeeding education and support versus routine care. The intervention will be provided by Women Development Army leaders who are already in the country's health system using a 40-h WHO breastfeeding counseling course, "Infant and Young Child Feeding Counseling: an integrated course" and the "Training of Trainers Manual for Counseling on Maternal, Infant and Young Child Nutrition" in the local language. Culturally appropriate operational packages of information will be developed for them. Using preset criteria at least 432 pregnant women in their third trimester will be recruited from 36 zones. Visits in the intervention arm include two prenatal visits and 8 postnatal visits. Supervisory visits will be conducted monthly to each intervention zone. Data will be entered into Epi-data version 3.1 and analyzed using STATA version 13.0. All analysis will be done by intention to treat analysis. We will fit mixed-effects linear regression models for the continuous outcomes and mixed-effects linear probability models for the binary outcomes with study zone as random intercept to estimate study arm difference (intervention vs. routine education) adjusted for baseline value of the outcome and additional relevant covariates. The protocol was developed in collaboration with the Jimma Zone and Mana district Health office. Ethical clearance was obtained from the Institutional Review Board of University of Oslo and Jimma University. This study is partly funded by NORAD's NORHED programme.Discussion: We expect that the trial will generate findings that can inform breastfeeding policies and practices in Ethiopia.