Pre-lacteal FeedingNCT06236412
Effects of Breastfeeding Education Interventions During Pregnancy on Breastfeeding Practices in Rural South Ethiopia
A study testing Health education in people with Pre-lacteal Feeding and Colostrum Feeding, run by Wachemo University.
Trial 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. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Pre-lacteal Feeding, Colostrum Feeding, Early Initiation of Breastfeeding
- What is being tested?
- Health education
- Type of treatment
- Vaccines, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 510 participants
- Where
- No sites listed yet
- Study dates
- 20 Mar 2024to 20 Jun 2025
- 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 Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet.
About this study
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.
Read the 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.
- Conditions
- Pre-lacteal Feeding, Colostrum Feeding, Early Initiation of Breastfeeding, Exclusive Breastfeeding
- Being tested
- Health education
- Keywords
- Breastfeeding practice, Health education, Pregnancy, Rural
- Medical subject headings
- Breast Feeding, Health Education
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Health educationBehavioural
Health education about the contents listed under each arm will be provided for the participants.
| Study group | Role | What they receive |
|---|---|---|
| Intervention arm 1: pregnant woman alone | Experimental | 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) Receives: Behavioral: Health education |
| Intervention arm 2: Pregnant woman with mother-in-law | Experimental | 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) Receives: Behavioral: Health education |
| Control arm: 'Pregnant woman in routine care'. | Active comparator | 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) Receives: Behavioral: Health education |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pre-lacteal feeding
Pre-lacteal feeding is any fluid given to a child before breastfeeding starts. It can be honey, water, butter, etc. that can be given before newborn starts breastfeeding. In this study, the incidence of pre-lacteal feeding will be assessed by dividing the number of newborns who received pre-lacteal food/fluids to total number of live births. The data will be collected by asking mothers using a face-to-face interview questionnaire.
Measured: Pre-lacteal feeding will be ascertained in the first week of delivery.
Colostrum feeding
Colostrum is the first form of breastmilk that is released by the mammary glands after giving birth. It's nutrient-dense and high in antibodies and antioxidants to build a newborn baby's immune system. It changes to breast milk within two to four days after the baby is born. In this study, the incidence of colostrum feeding will be assessed by dividing the number of newborns who feed colostrum to the number of total live births. The data will be collected by asking mothers about whether they give colostrum to the newborn baby or not, using a face-to-face interview questionnaire.
Measured: First week of delivery.
Early initiation of breastfeeding
Early initiation of breastfeeding is breastfeeding a newborn within one hour of birth. It protects the newborn from acquiring infection and reduces newborn mortality. It facilitates emotional bonding of the mother and the baby and has a positive impact on duration of exclusive breastfeeding. In this study, the incidence of early initiation of breastfeeding will be assessed by dividing the number of newborns who initiated breastfeeding within one hour of birth to the number of total live births. The data will be collected by asking mothers whether they breast fed the newborn within one hour or not, using a face-to-face interview questionnaire.
Measured: in this study, early initiation of breastfeeding will be ascertained in the first week of delivery
Exclusive breastfeeding
Exclusive breastfeeding means that the infant receives only breast milk. No other liquids or solids are given - not even water - with the exception of oral rehydration solution, or drops/syrups of vitamins, minerals or medicines. In this study, the incidence of exclusive breastfeeding will be assessed by dividing the number of newborns who fed breast milk for up to six months to total number of newborns. The data will be collected by asking mothers using a face-to-face interview questionnaire.
Measured: In this study, exclusive breastfeeding will be evaluated within one week after six months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2024
- Study start20 Mar 2024 (estimated)
- Primary completion20 May 2025 (estimated)
- Study completion20 Jun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Pre-lacteal FeedingStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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).
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 510 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Wachemo University
- Sponsor type
- University, hospital or other
- Collaborators
- Nestlé Foundation
- Responsible party
- Principal investigator, Belayneh Hamdela Jena, Wachemo University
- Investigators
- Belayneh H Jena, PhD, Principal investigator, Wachemo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06236412
- Sponsor's protocol ID
- WachemoU
- Status last verified
- Jan 2024
- First submitted
- 11 Jan 2024
- Last updated
- 1 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The IPD will not be shared for anyone. In this study, the participants data will be used for the analysis purpose only, which will be managed by the principal investigator.
Publications
Infant and Young Child Feeding: Model Chapter for Textbooks for Medical Students and Allied Health Professionals. Geneva: World Health Organization; 2009. Available from http://www.ncbi.nlm.nih.gov/books/NBK148965/
PubMed 23905206Takele WW, Tariku A, Wagnew F, Ekubagewargies DT, Getinet W, Derseh L, Anlay DZ. Magnitude of prelacteal feeding practice and its association with place of birth in Ethiopia: a systematic review and meta-analysis, 2017. Arch Public Health. 2018 Oct 22;76:63. doi: 10.1186/s13690-018-0308-y. eCollection 2018.
PubMed 30377528Gebretsadik GG, Tkuwab H, Berhe K, Mulugeta A, Mohammed H, Gebremariam A. Early initiation of breastfeeding, colostrum avoidance, and their associated factors among mothers with under one year old children in rural pastoralist communities of Afar, Northeast Ethiopia: a cross sectional study. BMC Pregnancy Childbirth. 2020 Aug 5;20(1):448. doi: 10.1186/s12884-020-03151-z.
PubMed 32758166Temesgen H, Negesse A, Woyraw W, Getaneh T, Yigizaw M. Prelacteal feeding and associated factors in Ethiopia: systematic review and meta-analysis. Int Breastfeed J. 2018 Nov 28;13:49. doi: 10.1186/s13006-018-0193-6. eCollection 2018.
PubMed 30505338Mose A, Dheresa M, Mengistie B, Wassihun B, Abebe H. Colostrum avoidance practice and associated factors among mothers of children aged less than six months in Bure District, Amhara Region, North West, Ethiopia: A community-based cross-sectional study. PLoS One. 2021 Jan 29;16(1):e0245233. doi: 10.1371/journal.pone.0245233. eCollection 2021.
PubMed 33513154Tsegaye D, Tamiru D, Belachew T. Effect of a theory-based nutrition education intervention during pregnancy through male partner involvement on newborns' birth weights in Southwest Ethiopia. A three-arm community based Quasi-Experimental study. PLoS One. 2023 Jan 17;18(1):e0280545. doi: 10.1371/journal.pone.0280545. eCollection 2023.
PubMed 36649344Abdulahi M, Fretheim A, Argaw A, Magnus JH. Breastfeeding Education and Support to Improve Early Initiation and Exclusive Breastfeeding Practices and Infant Growth: A Cluster Randomized Controlled Trial from a Rural Ethiopian Setting. Nutrients. 2021 Apr 6;13(4):1204. doi: 10.3390/nu13041204.
PubMed 33917366Hemming K, Girling AJ, Sitch AJ, Marsh J, Lilford RJ. Sample size calculations for cluster randomised controlled trials with a fixed number of clusters. BMC Med Res Methodol. 2011 Jun 30;11:102. doi: 10.1186/1471-2288-11-102.
PubMed 21718530Jena BH, Gemecho TL, Turuse EA, Kebede BA, Adem ZA, Melaku LM, Abageda M, Agde ZD, Gelaye KA. Effectiveness of breastfeeding educational interventions during pregnancy on breastfeeding practices in rural Central Ethiopia: cluster randomized controlled trial. BMC Public Health. 2026 Jun 6. doi: 10.1186/s12889-026-28088-4. Online ahead of print.
PubMed 42251277Jena BH, Gemecho TL, Turuse EA, Kebede BA, Adem ZA, Melaku LM, Gelaye KA. Effects of breastfeeding education interventions during pregnancy on breastfeeding practices in rural South Ethiopia: a protocol for cluster randomized controlled trial. BMC Pregnancy Childbirth. 2025 Nov 17;25(1):1224. doi: 10.1186/s12884-025-08290-9.
PubMed 41249976
Study at a glance
From the registry record, last updated by the sponsor on 1 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Breastfeeding Education Interventions During Pregnancy on Breastfeeding Practices in Rural South Ethiopia
- ClinicalTrials.gov ID
- NCT06236412
- Acronym / sponsor ID
- WachemoU
- Conditions
- Pre-lacteal Feeding, Colostrum Feeding, Early Initiation of Breastfeeding, Exclusive Breastfeeding
- Keywords
- Breastfeeding practice, Health education, Pregnancy, Rural
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 510 participants (estimated)
- Lead sponsor
- Wachemo UniversityUniversity, hospital or other
- Collaborators
- Nestlé Foundation
- Study start
- 20 Mar 2024 (estimated)
- Primary completion
- 20 May 2025 (estimated)
- Study completion
- 20 Jun 2025 (estimated)
- First posted
- 1 Feb 2024 (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.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
- 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).
| Arm | Type | Receives |
|---|---|---|
| Intervention arm 1: pregnant woman alone | Experimental | Behavioral: Health educationBreastfeeding 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) |
| Intervention arm 2: Pregnant woman with mother-in-law | Experimental | Behavioral: Health educationBreastfeeding 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) |
| Control arm: 'Pregnant woman in routine care'. | Active comparator | Behavioral: Health educationPregnant 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) |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (3 listed)
- 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
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 |
|---|---|---|
| Health educationHealth education about the contents listed under each arm will be provided for the participants. | Behavioural | Control arm: 'Pregnant woman in routine care'., Intervention arm 1: pregnant woman alone, Intervention arm 2: Pregnant woman with mother-in-law |
Primary outcome
Pre-lacteal feeding
Time frame: Pre-lacteal feeding will be ascertained in the first week of delivery.
Pre-lacteal feeding is any fluid given to a child before breastfeeding starts. It can be honey, water, butter, etc. that can be given before newborn starts breastfeeding. In this study, the incidence of pre-lacteal feeding will be assessed by dividing the number of newborns who received pre-lacteal food/fluids to total number of live births. The data will be collected by asking mothers using a face-to-face interview questionnaire.
Colostrum feeding
Time frame: First week of delivery.
Colostrum is the first form of breastmilk that is released by the mammary glands after giving birth. It's nutrient-dense and high in antibodies and antioxidants to build a newborn baby's immune system. It changes to breast milk within two to four days after the baby is born. In this study, the incidence of colostrum feeding will be assessed by dividing the number of newborns who feed colostrum to the number of total live births. The data will be collected by asking mothers about whether they give colostrum to the newborn baby or not, using a face-to-face interview questionnaire.
Early initiation of breastfeeding
Time frame: in this study, early initiation of breastfeeding will be ascertained in the first week of delivery
Early initiation of breastfeeding is breastfeeding a newborn within one hour of birth. It protects the newborn from acquiring infection and reduces newborn mortality. It facilitates emotional bonding of the mother and the baby and has a positive impact on duration of exclusive breastfeeding. In this study, the incidence of early initiation of breastfeeding will be assessed by dividing the number of newborns who initiated breastfeeding within one hour of birth to the number of total live births. The data will be collected by asking mothers whether they breast fed the newborn within one hour or not, using a face-to-face interview questionnaire.
Exclusive breastfeeding
Time frame: In this study, exclusive breastfeeding will be evaluated within one week after six months.
Exclusive breastfeeding means that the infant receives only breast milk. No other liquids or solids are given - not even water - with the exception of oral rehydration solution, or drops/syrups of vitamins, minerals or medicines. In this study, the incidence of exclusive breastfeeding will be assessed by dividing the number of newborns who fed breast milk for up to six months to total number of newborns. The data will be collected by asking mothers using a face-to-face interview questionnaire.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Feb 2024.
- Results publication: PubMed 23905206Infant and Young Child Feeding: Model Chapter for Textbooks for Medical Students and Allied Health Professionals. Geneva: World Health Organization; 2009. Available from http://www.ncbi.nlm.nih.gov/books/NBK148965/
- Results publication: PubMed 30377528Takele WW, Tariku A, Wagnew F, Ekubagewargies DT, Getinet W, Derseh L, Anlay DZ. Magnitude of prelacteal feeding practice and its association with place of birth in Ethiopia: a systematic review and meta-analysis, 2017. Arch Public Health. 2018 Oct 22;76:63. doi: 10.1186/s13690-018-0308-y. eCollection 2018.
- Results publication: PubMed 32758166Gebretsadik GG, Tkuwab H, Berhe K, Mulugeta A, Mohammed H, Gebremariam A. Early initiation of breastfeeding, colostrum avoidance, and their associated factors among mothers with under one year old children in rural pastoralist communities of Afar, Northeast Ethiopia: a cross sectional study. BMC Pregnancy Childbirth. 2020 Aug 5;20(1):448. doi: 10.1186/s12884-020-03151-z.
- Results publication: PubMed 30505338Temesgen H, Negesse A, Woyraw W, Getaneh T, Yigizaw M. Prelacteal feeding and associated factors in Ethiopia: systematic review and meta-analysis. Int Breastfeed J. 2018 Nov 28;13:49. doi: 10.1186/s13006-018-0193-6. eCollection 2018.
- Results publication: PubMed 33513154Mose A, Dheresa M, Mengistie B, Wassihun B, Abebe H. Colostrum avoidance practice and associated factors among mothers of children aged less than six months in Bure District, Amhara Region, North West, Ethiopia: A community-based cross-sectional study. PLoS One. 2021 Jan 29;16(1):e0245233. doi: 10.1371/journal.pone.0245233. eCollection 2021.
- Results publication: PubMed 36649344Tsegaye D, Tamiru D, Belachew T. Effect of a theory-based nutrition education intervention during pregnancy through male partner involvement on newborns' birth weights in Southwest Ethiopia. A three-arm community based Quasi-Experimental study. PLoS One. 2023 Jan 17;18(1):e0280545. doi: 10.1371/journal.pone.0280545. eCollection 2023.
- Results publication: PubMed 33917366Abdulahi M, Fretheim A, Argaw A, Magnus JH. Breastfeeding Education and Support to Improve Early Initiation and Exclusive Breastfeeding Practices and Infant Growth: A Cluster Randomized Controlled Trial from a Rural Ethiopian Setting. Nutrients. 2021 Apr 6;13(4):1204. doi: 10.3390/nu13041204.
- Results publication: PubMed 21718530Hemming K, Girling AJ, Sitch AJ, Marsh J, Lilford RJ. Sample size calculations for cluster randomised controlled trials with a fixed number of clusters. BMC Med Res Methodol. 2011 Jun 30;11:102. doi: 10.1186/1471-2288-11-102.
- Derived from this study: PubMed 42251277Jena BH, Gemecho TL, Turuse EA, Kebede BA, Adem ZA, Melaku LM, Abageda M, Agde ZD, Gelaye KA. Effectiveness of breastfeeding educational interventions during pregnancy on breastfeeding practices in rural Central Ethiopia: cluster randomized controlled trial. BMC Public Health. 2026 Jun 6. doi: 10.1186/s12889-026-28088-4. Online ahead of print.
- Derived from this study: PubMed 41249976Jena BH, Gemecho TL, Turuse EA, Kebede BA, Adem ZA, Melaku LM, Gelaye KA. Effects of breastfeeding education interventions during pregnancy on breastfeeding practices in rural South Ethiopia: a protocol for cluster randomized controlled trial. BMC Pregnancy Childbirth. 2025 Nov 17;25(1):1224. doi: 10.1186/s12884-025-08290-9.
- Ethiopia Demographic and Health Survey 2016Link provided by the sponsor.
- Training-of-trainers-manual-for-counseling-on-maternal-infant-and-young-child-nutritionLink provided by the sponsor.
- Individual participant dataSharing planned: No. The IPD will not be shared for anyone. In this study, the participants data will be used for the analysis purpose only, which will be managed by the principal investigator.
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.
Belayneh H Jena, PhD principal investigator
Wachemo University
Questions about this trial
What is this clinical trial studying?
A study testing Health education in people with Pre-lacteal Feeding and Colostrum Feeding, run by Wachemo University.
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 4 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 1 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Belayneh H Jena, PhD (+251945845544 ext. +251916718126, bhamdela@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pre-lacteal feeding (time frame: Pre-lacteal feeding will be ascertained in the first week of delivery.). The study lists 4 primary outcomes in all. 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 NCT06236412, which also lists 10 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 1 Feb 2024.