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临床试验/NCT05173454
NCT05173454已完成不适用

Effect of Breastfeeding Education and Support Provided to Male Partners on Optimal Breastfeeding Practice in Hadiya Zone, Southern Ethiopia: A Cluster-Randomized Controlled Trial

Jimma University1 个研究点 分布在 1 个国家目标入组 408 人开始时间: 2022年7月14日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
408
试验地点
1
主要终点
Optimal breastfeeding practice

研究概览

简要总结

Optimal breastfeeding practices are essential for child survival, growth, development, and for the health of mothers. Globally, optimal breastfeeding practices are still low and breastfeeding practices are not optimal in Ethiopia. Male partners have an important but often neglected role in the promotion of breastfeeding practices and currently, male partners are not targeted in breastfeeding education provided by health care providers. The effect of breastfeeding interventions delivered to male partners on optimal breastfeeding has not been studied in the Ethiopian context. It is important to investigate breastfeeding promotion education and support provided to male partners compared to the usual care effective in improving optimal breastfeeding practice in lactating mothers. Therefore, in this study cluster-randomized controlled trials will be conducted to evaluate the effect of breastfeeding education and support provided to male partners on optimal breastfeeding practice in Ethiopia.

详细描述

Optimal breastfeeding practices are essential for child survival, growth, development, and for the health of mothers. Globally, optimal breastfeeding practices are still low: less than 42% of new-borns begin breastfeeding in the first hour after birth, 41% of infants less than 6 months of age are exclusively breastfed and only 45% of mothers continue breastfeeding for at least two years. It's estimated that 823,000 deaths of children could be prevented every year through optimal breastfeeding practices. However, breastfeeding practices are not optimal in Ethiopia. Male partners have an important but often neglected role in the promotion of breastfeeding practices and currently, participants are not targeted in breastfeeding education provided by health care providers. The effect of breastfeeding interventions delivered to male partners on optimal breastfeeding has not been studied in the Ethiopian context.

The aim of this study is to evaluate the effect of breastfeeding education and support provided to male partners on optimal breastfeeding practice in Hadiya Zone, southern Ethiopia. A cluster-randomized controlled trial will be conducted. The intervention will be provided to the mothers and male partners by trained village health workers . The male partners in the intervention group will receive breastfeeding education and support, but participants in the control group will receive routine care. The breastfeeding education and support intervention package is comprised of four components: 1) Paternal and maternal group education, 2) providing specific take-home print materials, 3) Telephone call counseling and 4) Individual home visit. A total of 408 couples in third trimester pregnancy will be recruited to either the intervention group (204) or a control group (204) from 16 clusters. Clusters will be Kebeles (lowest administrative unit). Randomization will be conducted at the cluster level.Study assessors will be masked. Data analysis will be conducted by STATA version 14.0 using an Intention-To-Treat Approach. Generalized Estimating Equation (GEE) model will be used to determine the effect of the intervention on optimal breastfeeding practice. P values < 0.05 will be used to declare statistical significance. The duration of the intervention is six months.

研究设计

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

盲法说明

The intervention will be single-blinded. The outcome assessors will be masked.

入排标准

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

入选标准

  • Male partner and mother being in the third trimester of pregnancy
  • Male partner and Healthy mother with no underlying disease.
  • Male partner and Healthy mother with no pregnancy complication.
  • Male partner who live with their wives at home or maintain regular communication with them.
  • Partners capable of giving informed consent
  • Partners living in the selected cluster with no plans to move away during the intervention period

排除标准

  • Mother who experienced a pregnancy loss (miscarriage, still birth, neonatal death) during the follow up period
  • Mother had serious medical problems
  • Couples who divorced or separated or migrated out of the study area during the intervention
  • Mother with twins birth
  • Infants admitted to neonatal intensive care units at birth

结局指标

主要结局

Optimal breastfeeding practice

时间窗: at 6 months

Mothers will be asked about infant breastfeeding practice includes early initiation of breastfeeding, breastfeeding frequently (24-h recall), exclusive breastfeeding (24-h recall), intended duration of breastfeeding, pre-lacteal feeding, and feeding colostrum. The infant breastfeeding practice scores will be summed to give a total score that could range between 0 and 6. The infant breastfeeding practice scores will be then classified as Poor (0-2), Medium (3-4), or Good (5-6). When the study participants have scored the highest tertiles (good) of infant breastfeeding practice scores will be considered as optimal breastfeeding practices.

次要结局

  • Maternal breastfeeding self-efficacy(Baseline and at month 6)
  • Maternal Perceptions on male partners' breastfeeding Support(Baseline and at month 6)
  • Prevalence of child morbidity(at 6)
  • Paternal knowledge, attitude and Supportive practice on optimal breastfeeding(Baseline and at month 6)

研究者

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

Mulatu Abageda Anamo

Principal Investigator

Jimma University

研究点 (1)

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