Clinical trial NCT06236412: Effects of Breastfeeding Education Interventions During Pregnancy on Breastfeeding Practices in Rural South Ethiopia
Official title: Effects of Breastfeeding Education Interventions During Pregnancy on Breastfeeding Practices in Rural South Ethiopia
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Pre-lacteal Feeding
Colostrum Feeding
Early Initiation of Breastfeeding
Exclusive Breastfeeding
Keywords: Breastfeeding practice
Health education
Pregnancy
Rural
Lead sponsor: Wachemo University
Sponsor class: OTHER
Collaborators: name: Nestlé Foundation
First posted: 2024-02-01
Enrollment: 510
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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 purpose: PREVENTION

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Pre-lacteal feeding
timeFrame: Pre-lacteal feeding will be ascertained in the first week of delivery.
measure: Colostrum feeding
timeFrame: First week of delivery.
measure: Early initiation of breastfeeding
timeFrame: in this study, early initiation of breastfeeding will be ascertained in the first week of delivery
measure: Exclusive breastfeeding
timeFrame: In this study, exclusive breastfeeding will be evaluated within one week after six months.
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Wachemo University
name: Belayneh H Jena, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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