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Clinical Trial Summary

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.


Clinical Trial Description

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. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05173454
Study type Interventional
Source Jimma University
Contact
Status Completed
Phase N/A
Start date July 14, 2022
Completion date October 30, 2023

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