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

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

510 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-03-20

Study Completion Date

2025-06-20

Brief Summary

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Background: Breast milk is primary source of nutrition for newborns, containing both macro and micro nutrients. However, breastfeeding practices vary from setting-to-setting, and affect newborn's growth and development. In Ethiopia, sizable proportion of newborns (19%) do not feed colostrum; instead, pre-lacteal foods are given until colostrum is partly or fully removed. This obviously delays timely initiation, and affects exclusive breastfeeding. Furthermore, avoiding colostrum and giving pre-lacteal foods make newborns more susceptible for infections and/or diarrheal diseases that lead to death. Additionally, 26% of newborns exposed for pre-lacteal feeding, 27% initiate breastfeeding lately and 41% do not exclusively breastfed. These problems of breastfeeding usually happen due to limited access to health information about harmful effects in wider community. Mother-in-laws are influential people in the family, including them in breastfeeding education in addition to mothers may improve children's health status and survival.

Objectives: To evaluate effects of breastfeeding education interventions on breastfeeding practices in rural South Ethiopia.

Methods: Community-based, cluster randomized controlled trial, using three-arms parallel group design will be conducted among 510 pregnant women who will be enrolled between the end of first trimester and early second trimester (\<16 weeks) of pregnancy. The three arms are: mother alone, mother with mother-in-law and control arm (routine care). The study include 51 non-adjacent clusters (kebeles) for the three arms. This helps minimize information contamination. We implement a simple randomization technique to allocate interventions and control clusters. Interventions will be given at home in eight phases: six times during pregnancy (monthly starting from 4th month up to 9th month), and two times after delivery (within one week and last week of third month). The outcomes are pre-lacteal feeding, colostrum feeding, early initiation and exclusive breastfeeding.

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Detailed Description

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Globally, breastfeeding is recognized as one of the most effective strategies to ensure child health and survival, especially in low and middle-income countries, including Ethiopia, where breast milk substitutes are not always feasible. This is because breast milk is safe, clean, and contains antibodies that help protect against many common childhood illnesses such as acute respiratory infections and diarrheal diseases. In addition, breast milk contains both macro and micro-nutrients that provide nutritional needs, especially in the first six months, and later through complementary foods.

The World Health Organization (WHO) and United Nations Children's Fund (UNICEF) recommend that children initiate breastfeeding within the first hour of birth and be exclusively breastfed for the first 6 months of life, meaning no other foods or liquids are provided, including water.

In Ethiopia, there is a good culture of breastfeeding for a longer duration, as 76% of mothers breastfed their child for at least 2 years, and the median duration of breastfeeding was 23.9 months. However, contrary to the recommendations, still sizeable proportion (41%) of infants do not exclusively breastfeed, 27-36% do not initiate breastfeeding early, 25-46% give pre-lacteal foods/fluids such as butter, honey, and plain water. The first breast milk (colostrum) is also commonly avoided (19-77%) until it is partly or fully removed through manual expression. According to the most recent UNICEF report, the proportion of infants who do not exclusively breastfeed and initiate breastfeeding timely (within 1 hour) were 39% and 77%, respectively. These problems of breastfeeding usually happen due to limited access to health information about harmful effects in the wider community.

Studies reported that, among other factors, poor knowledge of mothers and absence of breastfeeding counseling were significantly associated with poor breastfeeding practices. This suggests that there is a need to increase knowledge through health education to improve breastfeeding practices.

The World Health Assembly (WHA) has set a target to increase the exclusive breastfeeding rate to 50% by 2025. WHO actively promotes breastfeeding as the best source of nourishment for infants and young children, and is working to achieve this target. Ethiopia has made commitments and achieved the target, as the country reached a 59% exclusive breastfeeding rate in 2019. The progress must continue so that all children are able to thrive and the country achieves global targets set by the United Nations, the Sustainable Development Goals (goal 3), to reduce neonatal and child mortalities. Nutrition during pregnancy and childhood is one of Ethiopia's government priority areas, and one of the strategies for child survival is to promote good practices of breastfeeding during the early life of the neonate and good complementary feeding thereafter.

Although pregnancy and childbirth are unique features of women and their contribution is paramount, recognizing the importance of influential peoples in the families such as the husband/partner and mother-in-law is crucial for effective implementations of child health services such as breastfeeding. The husband/partner is an influential person in the family in making decisions about health care in general. In Ethiopia, the mother-in-laws are the most influential people in the family, even they influence more than a husband, especially in breastfeeding practices such as pre-lacteal feeding, colostrum avoidance behavior, and exclusive breastfeeding. They are the one who give the pre-lacteal foods, manually discard colostrum, and push mothers to give foods and fluids for newborns. Mothers, especially young, usually listen and accept the suggestions from mother-in-laws, as they judged as experienced women in pregnancy and childbirth related issues, including feeding newborns and rearing children. In Ethiopia, women usually receive routine maternal and child health care services, while influential peoples such as husband and mother-in-law are commonly overlooked and not involved in the educational services. Previous interventional studies that involved husbands in maternal and child health services education found that men's involvement has a positive impact on improving the utilization of the services. Likewise, previous interventional study conducted in Ethiopia via involving influential peoples in the community (Women Development Army (WAD) leaders found to improve early initiation of breastfeeding and exclusive breastfeeding practices. However, there is a scarcity of evidence that reports the effect of breastfeeding education interventions of mothers and mother-in-laws on improving good practices of breastfeeding in Ethiopia, where people with various socio-cultural characteristics and breastfeeding cultures exist. This is relevant for decision-making in a broader context and to decrease economic losses related to poor practices of breastfeeding, such as household expenditures for treatment and breast milk substitutes when the child gets sick, loss of productive time by parents for caring sick child, and burden on the health care system.

Therefore, this study will provide useful evidence for the implementation of good breastfeeding practices to enhance child health and survival.

Conditions

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Pre-lacteal Feeding Colostrum Feeding Early Initiation of Breastfeeding Exclusive Breastfeeding

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Cluster randomized controlled trial using a three-arm parallel group design will be implemented. A post-test only trial design. The three arms are: pregnant woman alone, pregnant woman with mother-in-law, and pregnant woman in routine care (control).

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Outcome Assessors

Outcome assessors are data collectors who will be trained for only outcome data collection. They will not be involved in any manipulations other than outcome data collection. They will not be involved in baseline data collection as well. They will not have information about which group receive the intervention and which group not. Their only purpose is to interview participants about the outcome status, which will be prepared by the investigators.

Study Groups

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Intervention arm 1: pregnant woman alone

Breastfeeding education:

Breast milk features, contents, advantages, how to improve its quality, and quantity.

Pre-lacteal feeding: meaning, addressing misconceptions, to avoid any foods/fluids up to 6 months and its harmful effects Colostrum feeding: meaning, its contents, advantages and addressing related misconceptions Early initiation of breastfeeding: proper time to initiation of breastfeeding \& advantages for mother \& child Exclusive breastfeeding: meaning, advantages, how long to exclusively breastfed.

They will also receive iron suphate/folic acid supplementation as recommended practice, at least for 90 days (90+ days)

Group Type EXPERIMENTAL

Health education

Intervention Type BEHAVIORAL

Health education about the contents listed under each arm will be provided for the participants.

Intervention arm 2: Pregnant woman with mother-in-law

Breastfeeding education:

Breast milk features, contents, advantages, how to improve its quality, and quantity.

Pre-lacteal feeding: meaning, addressing misconceptions, to avoid any foods/fluids up to 6 months and its harmful effects Colostrum feeding: meaning, its contents, advantages and addressing related misconceptions Early initiation of breastfeeding: proper time to initiation of breastfeeding \& advantages for mother \& child Exclusive breastfeeding: meaning, advantages, how long to exclusively breastfed.

They will also receive iron suphate/folic acid supplementation as recommended practice, at least for 90 days (90+ days)

Group Type EXPERIMENTAL

Health education

Intervention Type BEHAVIORAL

Health education about the contents listed under each arm will be provided for the participants.

Control arm: 'Pregnant woman in routine care'.

Pregnant women in this arm receive routine care, which includes existing community and health facility-based health care. The routine (standard) care at the community level includes those services given by the health extension workers such as hygiene (personal, food and environmental hygiene), and family health services such as antenatal care, postnatal care, immunization, breastfeeding, nutrition. In this trial, the control arm will receive counseling about antenatal care, health facility delivery, postnatal care, dietary intake (additional meal during pregnancy and after delivery), hygiene, and less deep information about breastfeeding practices such as on demand feeding day and night, exclusive breastfeeding, continuing breastfeeding for at least 24 months, to balance and make the frequency and duration with that of the intervention arm. They will also receive iron suphate/folic acid supplementation as recommended practice, at least for 90 days (90+ days)

Group Type ACTIVE_COMPARATOR

Health education

Intervention Type BEHAVIORAL

Health education about the contents listed under each arm will be provided for the participants.

Interventions

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Health education

Health education about the contents listed under each arm will be provided for the participants.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* Pregnant women who are in between the end of their first trimester and the early second trimester (\<16 weeks) of pregnancy
* Pregnant women who have not given birth before (nullipara)
* Pregnant women who will give consent
* Pregnant women who have resided in the study area for at least six months.

Exclusion Criteria

* Pregnant women with previous history of stillbirth
* Pregnant women whose mother-in-law died or unavailable
* Pregnant women who already received breastfeeding practice education intervention from previous trials

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No