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Clinical Trials/NCT05173454
NCT05173454
Completed
N/A

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 site in 1 country408 target enrollmentJuly 14, 2022

Overview

Phase
N/A
Intervention
Not specified
Conditions
Breastfeeding
Sponsor
Jimma University
Enrollment
408
Locations
1
Primary Endpoint
Optimal breastfeeding practice
Status
Completed
Last Updated
2 years ago

Overview

Brief 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.

Registry
clinicaltrials.gov
Start Date
July 14, 2022
End Date
October 30, 2023
Last Updated
2 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Mulatu Abageda Anamo

Principal Investigator

Jimma University

Eligibility Criteria

Inclusion Criteria

  • 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

Exclusion Criteria

  • 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

Outcomes

Primary Outcomes

Optimal breastfeeding practice

Time Frame: 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.

Secondary Outcomes

  • 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)

Study Sites (1)

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