BreastfeedingNCT05173454
Effect of Breastfeeding Education and Support Provided to Male Partners on Optimal Breastfeeding Practice in Ethiopia
A study testing Breastfeeding Education and Support in people with Breastfeeding and Breast Fed, run by Jimma University at 1 site in Ethiopia.
Trial 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. Read more about this study
- Who is it for?
- Ages 15 years and olderHealthy volunteers can take part
- Conditions the study is for
- Breastfeeding, Breast Fed, Breast Feeding, Exclusive
- What is being tested?
- Breastfeeding Education and Support
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 408 participants
- Where
- 1 siteEthiopia
- Study dates
- 14 Jul 2022to 30 Oct 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Ethiopia1 site
Hadiya Zone
Awasa, Southern Nations, Nationalities, and Peoples' Region
About this study
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
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.
Read the 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.
- Being tested
- Breastfeeding Education and Support
- Keywords
- optimal breastfeeding practice, male partner, education and support, Ethiopia
- Medical subject headings
- Breast Feeding
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Breastfeeding Education and SupportBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Breastfeeding Education and Support |
| Usual or routine care | No intervention | The routine care will be continued in the control group. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: at 6 months
Secondary outcomes (4)
Paternal knowledge, attitude and Supportive practice on optimal breastfeeding
Paternal knowledge towards optimal breastfeeding practice will be measured using the breastfeeding knowledge questionnaire after validating it. Paternal attitude towards optimal breastfeeding will be measured using the Iowa Infant Feeding Attitude Scale after validating it. The total score will be calculated out of 85, with a minimum of 17 and a maximum of 85. This scale will help to identify the attitude of the male partner for capturing the favourable attitude (above the mean score) and unfavourable attitude (below the mean score) towards breastfeeding. The supportive practice of male partners in optimal breastfeeding practice will be measured by using a questionnaire which will be coded into Yes or No responses and one mark will be awarded for every correct response (yes), zero will be awarded for every incorrect response (no).Hence, the total number of marks in the supportive practice ranged from 0 to 8.
Measured: Baseline and at month 6
Maternal breastfeeding self-efficacy
Maternal Breastfeeding Self-Efficacy refers to a mother's confidence in her ability to breastfeed her infant and it will be measured using the Breastfeeding Self Efficacy Scale-Short Form developed to assess breastfeeding self-efficacy during postnatal period, a 14-item, self-report instrument and scored in 5-point Likert-type scale.Items are presented positively and summed to produce a total score ranging from 14 to 70, with higher scores indicating higher levels of breastfeeding self-efficacy.
Measured: Baseline and at month 6
Prevalence of child morbidity
Prevalence of child morbidity will be measured based on three morbidities such as diarrhea, fever and acute respiratory illnesses (ARIs). Children with at-least one of the three morbidity during intervention period will be considered
Measured: at 6
Maternal Perceptions on male partners' breastfeeding Support
Male partners' support for breastfeeding will be defined as the physical, emotional and psychosocial support the mother receives from her husband during breastfeeding. Maternal perceptions on husbands' breastfeeding Support will be measured by Postpartum Partner Support Scale, a 25-item self-report instrument designed to assess partner postpartum perceptions of support. Items are rated on a 4-point scale to produce a summative score ranging from 25 to 100, with higher scores indicating higher levels of maternal Perceptions on postpartum-specific partner support.
Measured: Baseline and at month 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Dec 2021
- Study start14 Jul 2022
- Primary completion25 Oct 2023
- Study completion30 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for BreastfeedingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 408 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jimma University
- Sponsor type
- University, hospital or other
- Collaborators
- Nestlé Foundation
- Responsible party
- Principal investigator, Mulatu Abageda Anamo, Jimma University
- Investigators
- Mulatu A Anamo, MSc, Principal investigator, Wachemo UniversityTefera B Lema, PhD, Study director, Jimma UniversityMubarek Abera, PhD, Study director, Jimma University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05173454
- Sponsor's protocol ID
- RP 0896/11
- Status last verified
- Nov 2023
- First submitted
- 4 Dec 2021
- Last updated
- 14 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Baseline characteristics, outcome measure and statistical analysis
Publications
Abageda M, Jena BH, Agde ZD, Anamo WA, Belachew T. Effectiveness of Couple-Based Optimal Breastfeeding Promotion and Support Interventions on Child Morbidity in Central Ethiopia: A Cluster-Randomized Controlled Trial. Health Sci Rep. 2026 Feb 22;9(2):e71856. doi: 10.1002/hsr2.71856. eCollection 2026 Feb.
PubMed 41737425Abageda 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.
PubMed 39558214Abageda 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.
PubMed 39122804
Study at a glance
From the registry record, last updated by the sponsor on 14 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05173454
- Acronym / sponsor ID
- RP 0896/11
- Keywords
- optimal breastfeeding practice, male partner, education and support, Ethiopia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 408 participants (actual)
- Lead sponsor
- Jimma UniversityUniversity, hospital or other
- Collaborators
- Nestlé Foundation
- Study start
- 14 Jul 2022 (actual)
- Primary completion
- 25 Oct 2023 (actual)
- Study completion
- 30 Oct 2023 (actual)
- First posted
- 30 Dec 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Breastfeeding Education and Support | Experimental | Behavioral: Breastfeeding Education and SupportThe 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. |
| Usual or routine care | No intervention | –The routine care will be continued in the control group. |
Who may qualify
- Ages
- 15 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Breastfeeding 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. | Behavioural | Breastfeeding Education and Support |
Primary outcome
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.
4 secondary outcomes
Paternal knowledge, attitude and Supportive practice on optimal breastfeeding
Time frame: Baseline and at month 6
Maternal breastfeeding self-efficacy
Time frame: Baseline and at month 6
Prevalence of child morbidity
Time frame: at 6
Maternal Perceptions on male partners' breastfeeding Support
Time frame: Baseline and at month 6
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Nov 2023.
- Derived from this study: PubMed 41737425Abageda M, Jena BH, Agde ZD, Anamo WA, Belachew T. Effectiveness of Couple-Based Optimal Breastfeeding Promotion and Support Interventions on Child Morbidity in Central Ethiopia: A Cluster-Randomized Controlled Trial. Health Sci Rep. 2026 Feb 22;9(2):e71856. doi: 10.1002/hsr2.71856. eCollection 2026 Feb.
- Derived from this study: PubMed 39558214Abageda 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.
- Derived from this study: PubMed 39122804Abageda 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.
- Individual participant dataSharing planned: Yes. Baseline characteristics, outcome measure and statistical analysis
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mulatu A Anamo, MSc principal investigator
Wachemo University
Tefera B Lema, PhD study director
Jimma University
Mubarek Abera, PhD study director
Jimma University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Breastfeeding Education and Support in people with Breastfeeding and Breast Fed, run by Jimma University at 1 site in Ethiopia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Ethiopia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Optimal breastfeeding practice (time frame: at 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05173454, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Nov 2023.