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

NCT06236412 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 510

Last updated 2024-02-01

No results posted yet for this study

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

Interventions

BEHAVIORAL

Health education

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

Sponsors & Collaborators

  • Nestlé Foundation

    collaborator OTHER

  • Wachemo University

    lead OTHER

Principal Investigators

  • Belayneh H Jena, PhD · Wachemo University

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-03-20
Primary Completion
2025-05-20
Completion
2025-06-20

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06236412 on ClinicalTrials.gov