Clinical trial NCT05173454: Effect of Breastfeeding Education and Support Provided to Male Partners on Optimal Breastfeeding Practice in Ethiopia
Official title: Effect of Breastfeeding Education and Support Provided to Male Partners on Optimal Breastfeeding Practice in Hadiya Zone, Southern Ethiopia: A Cluster-Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breastfeeding
Breast Fed
Breast Feeding, Exclusive
Breastfed
Breastfeeding, Exclusive
Keywords: optimal breastfeeding practice
male partner
education and support
Ethiopia
Lead sponsor: Jimma University
Sponsor class: OTHER
Collaborators: name: Nestlé Foundation
First posted: 2021-12-30
Enrollment: 408
Sex: ALL
Minimum age (years): 15
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The study will have two arms, i.e., intervention and control groups. The intervention group will receive antenatal and postnatal breastfeeding education and support and control group will receive routine care.
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

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

Primary outcomes:
measure: Optimal breastfeeding practice
timeFrame: at 6 months
Secondary outcomes:
measure: Paternal knowledge, attitude and Supportive practice on optimal breastfeeding
timeFrame: Baseline and at month 6
measure: Maternal breastfeeding self-efficacy
timeFrame: Baseline and at month 6
measure: Prevalence of child morbidity
timeFrame: at 6
measure: Maternal Perceptions on male partners' breastfeeding Support
timeFrame: Baseline and at month 6
Other outcomes:
Locations:
city: Hawassa
country: Ethiopia
facility: Hadiya Zone
state: Southern Nations, Nationalities, And Peoples' Region
Study officials:
affiliation: Wachemo University
name: Mulatu A Anamo, MSc
role: PRINCIPAL_INVESTIGATOR
affiliation: Jimma University
name: Tefera B Lema, PhD
role: STUDY_DIRECTOR
affiliation: Jimma University
name: Mubarek Abera, PhD
role: STUDY_DIRECTOR
References: