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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

408 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-07-14

Study Completion Date

2023-10-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Effect of Breastfeeding Education and Support Intervention on Timely Initiation and Exclusive Breastfeeding

NCT03030651

Breastfeeding, Exclusive Nutrition Status

COMPLETED NA

Effects of Breastfeeding Education Interventions During Pregnancy on Breastfeeding Practices in Rural South Ethiopia

NCT06236412

Pre-lacteal Feeding Colostrum Feeding Early Initiation of Breastfeeding +1 more

NOT_YET_RECRUITING NA

The Impact of Breastfeeding Education on Breastfeeding Behavior and the Use of Traditional Practices

NCT04705675

Breastfeeding Breasfeeding Traditional Practices Post Procedural Discharge

COMPLETED NA

Paternal Support and Its Relationship With Breastfeeding Adaptation and Self-Efficacy

NCT07040254

Pregnancy Breastfeeding Education Breastfeeding Support +2 more

COMPLETED NA

Father-Focused Breastfeeding Education and Breastfeeding Outcomes

NCT07341256

Breastfeeding Paternal Support Exclusive Breastfeeding

RECRUITING NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

Breastfeeding Breast Fed Breast Feeding, Exclusive Breastfed Breastfeeding, Exclusive

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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 Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

SINGLE

Outcome Assessors

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

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Breastfeeding Education and Support

The intervention arm will receive antenatal and postnatal breastfeeding education and support intervention for six months starting in their third trimester pregnancy period. The intervention package is comprised of four components: Antenatal breastfeeding education, providing specific take-home print materials, Telephone call counseling and Individual home visit.

Group Type EXPERIMENTAL

Breastfeeding Education and Support

Intervention Type BEHAVIORAL

The 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.

Usual or routine care

The routine care will be continued in the control group.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Breastfeeding Education and Support

The 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.

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

15 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes