NCT05173454

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
408

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jul 2022

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 4, 2021

Completed
26 days until next milestone

First Posted

Study publicly available on registry

December 30, 2021

Completed
7 months until next milestone

Study Start

First participant enrolled

July 14, 2022

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 25, 2023

Completed
5 days until next milestone

Study Completion

Last participant's last visit for all outcomes

October 30, 2023

Completed
Last Updated

November 14, 2023

Status Verified

November 1, 2023

Enrollment Period

1.3 years

First QC Date

December 4, 2021

Last Update Submit

November 13, 2023

Conditions

Keywords

optimal breastfeeding practicemale partnereducation and supportEthiopia

Outcome Measures

Primary Outcomes (1)

  • Optimal breastfeeding practice

    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.

    at 6 months

Secondary Outcomes (4)

  • Paternal knowledge, attitude and Supportive practice on optimal breastfeeding

    Baseline and at month 6

  • Maternal breastfeeding self-efficacy

    Baseline and at month 6

  • Prevalence of child morbidity

    at 6

  • Maternal Perceptions on male partners' breastfeeding Support

    Baseline and at month 6

Study Arms (2)

Breastfeeding Education and Support

EXPERIMENTAL

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.

Behavioral: Breastfeeding Education and Support

Usual or routine care

NO INTERVENTION

The routine care will be continued in the control group.

Interventions

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.

Breastfeeding Education and Support

Eligibility Criteria

Age15 Years+
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hadiya Zone

Awasa, Southern Nations, Nationalities, and Peoples' Region, Ethiopia

Location

Related Publications (2)

  • Abageda M, Jena BH, Belachew T. Effect of Male Partner-Targeted Breastfeeding Education and Support Interventions on Optimal Breastfeeding Practices in Central Ethiopia: A Cluster Randomized Controlled Trial. Matern Child Nutr. 2025 Apr;21(2):e13764. doi: 10.1111/mcn.13764. Epub 2024 Nov 18.

  • Abageda M, Jena BH, Belachew T. Effectiveness of male partner-targeted breastfeeding education and support interventions on mothers' breastfeeding self-efficacy in central Ethiopia: a cluster-randomized controlled trial. Sci Rep. 2024 Aug 9;14(1):18563. doi: 10.1038/s41598-024-68032-3.

MeSH Terms

Conditions

Breast Feeding

Interventions

Palliative Care

Condition Hierarchy (Ancestors)

Feeding BehaviorBehavior

Intervention Hierarchy (Ancestors)

Patient CareTherapeuticsHealth ServicesHealth Care Facilities Workforce and Services

Study Officials

  • Mulatu A Anamo, MSc

    Wachemo University

    PRINCIPAL INVESTIGATOR
  • Tefera B Lema, PhD

    Jimma University

    STUDY DIRECTOR
  • Mubarek Abera, PhD

    Jimma University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
The intervention will be single-blinded. The outcome assessors will be masked.
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

December 4, 2021

First Posted

December 30, 2021

Study Start

July 14, 2022

Primary Completion

October 25, 2023

Study Completion

October 30, 2023

Last Updated

November 14, 2023

Record last verified: 2023-11

Data Sharing

IPD Sharing
Will share

Baseline characteristics, outcome measure and statistical analysis

Shared Documents
STUDY PROTOCOL, SAP, ICF, CSR

Locations