Effect of Breastfeeding Education and Support Intervention on Timely Initiation and Exclusive Breastfeeding
1 other identifier
interventional
469
1 country
1
Brief Summary
The purpose of this study is to develop and test Breastfeeding Education and Support Intervention for improving timely initiation and Exclusive Breastfeeding rate. Infant mortality rates are still high in Ethiopia. Breastfeeding (BF) is regarded as the simplest and least expensive strategy for reduction of infant mortality rates. Ethiopia does not meet the international recommendation for exclusive breastfeeding (EBF) for the first six months of life. Community-based educational and support interventions provided prenatally and postnatally are effective in increasing BF rates. However, there is paucity of such information in Ethiopia.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started May 2017
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 14, 2017
CompletedFirst Posted
Study publicly available on registry
January 25, 2017
CompletedStudy Start
First participant enrolled
May 8, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 8, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
September 8, 2018
CompletedMarch 22, 2019
March 1, 2019
1.3 years
January 14, 2017
March 21, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Exclusive breastfeeding
Prevalence of exclusive breastfeeding (24-h recall) at month one, three and six in the intervention and control clusters.
at six month
Secondary Outcomes (4)
Timely initiation of breastfeeding
within 72 hours after delivery
Nutritional status
at months 3 and 6
Knowledge towards breastfeeding
Baseline, at month 3 and 6
Attitude towards breastfeeding
Baseline, at month 3 and 6
Study Arms (2)
Breastfeeding Education and Support
EXPERIMENTALPregnant women in the intervention arm will receive breastfeeding education and support intervention for nine months starting in their third trimester
Usual or routine care
NO INTERVENTIONPregnant women in the intervention arm will continue to receive the usual/routine care.
Interventions
Women Development Army (WDA) leaders will function as peers for mothers in intervention group. There will be two visits during pregnancy and 8 visits postnatally. During pregnancy, WDA leaders will cover in detail the importance of EBF, feeding colostrum first, and discouraging prelacteal foods and encourage the mother to deliver at the nearby health center. During Postnatal visits, mothers will be observed positioning, attaching, and feeding the new-born, with appropriate feedback provided, solving any BF problems, encourage the mothers to continue exclusive breastfeeding for 6 months, emphasize nutrition for sufficient breast milk to breastfeed successfully and hands-on guidance only when necessary.
Eligibility Criteria
You may qualify if:
- During pregnancy
- pregnant women in the third trimester
- Live in the selected cluster and
- Have no plans to move away during the intervention period
- Without psychiatric illness
- Capable of giving informed consent and willing to be visited by supervisors and data collectors After delivery
- Singleton live birth with no severe malformation that could interfere with breastfeeding
You may not qualify if:
- During pregnancy
- women with severe psychological illness which could interfere with consent and study participation
- Severely ill After delivery
- Severely ill or have clinical complications warranting hospitalization
- Stillbirth
- Infant death or maternal death
- Twin gestation
- Preterm birth (at \<37 weeks gestation).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Jimma Universitylead
- University of Oslocollaborator
Study Sites (1)
Mana district, Jimma zone, Southwest Ethiopia
Jimma, Ethiopia
Related Publications (1)
Abdulahi M, Fretheim A, Magnus JH. Effect of breastfeeding education and support intervention (BFESI) versus routine care on timely initiation and exclusive breastfeeding in Southwest Ethiopia: study protocol for a cluster randomized controlled trial. BMC Pediatr. 2018 Sep 26;18(1):313. doi: 10.1186/s12887-018-1278-5.
PMID: 30257661DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Jeanette H. Magnus, PhD
University of Oslo
- STUDY DIRECTOR
Atle Fretheim, PhD
University of Oslo
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- OTHER
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor
Study Record Dates
First Submitted
January 14, 2017
First Posted
January 25, 2017
Study Start
May 8, 2017
Primary Completion
September 8, 2018
Study Completion
September 8, 2018
Last Updated
March 22, 2019
Record last verified: 2019-03
Data Sharing
- IPD Sharing
- Will share
participants flow, baseline characteristics, outcome measure statistical analysis