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

NCT06236412 | Unknown

• 1 other identifier: WachemoU
• Study Type: interventional
• Target: 510
• Locations: 0 countries
• Sites: N/A

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.

Conditions

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

Keywords

Breastfeeding practice; Health education; Pregnancy; Rural

Outcome Measures

Primary Outcomes (4)

• 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.

  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.

  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.

  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.

  In this study, exclusive breastfeeding will be evaluated within one week after six months.

Study Arms (3)

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)

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)

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)

Behavioral: Health education

Interventions

Health education BEHAVIORAL

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

Control arm: 'Pregnant woman in routine care'.; Intervention arm 1: pregnant woman alone; Intervention arm 2: Pregnant woman with mother-in-law

Eligibility Criteria

• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Wachemo University: lead
• Nestlé Foundation: collaborator

Related Publications (9)

• 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/

  PMID: 23905206 RESULT

• Takele 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.

  PMID: 30377528 RESULT

• Gebretsadik 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.

  PMID: 32758166 RESULT

• Temesgen 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.

  PMID: 30505338 RESULT

• Mose 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.

  PMID: 33513154 RESULT

• Tsegaye 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.

  PMID: 36649344 RESULT

• Abdulahi 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.

  PMID: 33917366 RESULT

• Hemming 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.

  PMID: 21718530 RESULT

• Jena 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.

  PMID: 41249976 DERIVED

Related Links

• Ethiopia Demographic and Health Survey 2016
• Training-of-trainers-manual-for-counseling-on-maternal-infant-and-young-child-nutrition

MeSH Terms

Conditions

Breast Feeding; Health Education

Condition Hierarchy (Ancestors)

Feeding Behavior; Behavior; Adherence Interventions; Medication Adherence; Patient Compliance; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior

Study Officials

• Belayneh H Jena, PhD

  Wachemo University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Belayneh H Jena, PhD

CONTACT

+251945845544; bhamdela@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Epidemiology

Model Details: 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).

Study Record Dates

• First Submitted: January 11, 2024
• First Posted: February 1, 2024
• Study Start: March 20, 2024
• Primary Completion: May 20, 2025
• Study Completion: June 20, 2025
• Last Updated: February 1, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share