Clinical Trials Directory

Trials / Completed

CompletedNCT05173454

Effect of Breastfeeding Education and Support Provided to Male Partners on Optimal Breastfeeding Practice in Ethiopia

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

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
408 (actual)
Sponsor
Jimma University · Academic / Other
Sex
All
Age
15 Years
Healthy volunteers
Accepted

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.

Detailed 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.

Conditions

Interventions

TypeNameDescription
BEHAVIORALBreastfeeding Education and SupportThe trained village health workers will provide breastfeeding education and support for male partners and mothers in intervention group for the six month period. During intervention trained village health workers will cover antenatal breastfeeding education to raise knowledge, awareness, support, and counseling on benefits of optimal breastfeeding practices and involvement in supporting breastfeeding mothers once at third trimester pregnancy period; Specific take-home print materials will be developed that support optimal breastfeeding practices and will be given for both partners during third trimester pregnancy; Telephone call counselling will be held to the male partners on optimal breastfeeding practices and involvement in supporting breastfeeding mothers at second week and third month postpartum and there will be three home visits during 6th week, 3.5 month and 5th month.

Timeline

Start date
2022-07-14
Primary completion
2023-10-25
Completion
2023-10-30
First posted
2021-12-30
Last updated
2023-11-14

Locations

1 site across 1 country: Ethiopia

Source: ClinicalTrials.gov record NCT05173454. Inclusion in this directory is not an endorsement.