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

Breastfeeding Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05173454
• Other study ID #: RP 0896/11
• Status: Completed
• Phase: N/A
• Start date: July 14, 2022
• Est. completion date: October 30, 2023

Study information

• Verified date: November 2023
• Source: Jimma University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 408
• Est. completion date: October 30, 2023
• Est. primary completion date: October 25, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 15 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Breast Feeding, Exclusive
• Breastfeeding
• Breastfeeding, Exclusive

Intervention

Behavioral:
• 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.

Locations

Country	Name	City	State
Ethiopia	Hadiya Zone	Hawassa	Southern Nations, Nationalities, And Peoples' Region

Sponsors (2)

Lead Sponsor	Collaborator
Jimma University	Nestlé Foundation

Country where clinical trial is conducted

Ethiopia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.	Baseline and at month 6
Secondary	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.	Baseline and at month 6
Secondary	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	at 6
Secondary	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.	Baseline and at month 6