BEP Targeting Strategies in Ethiopia
BEP
Targeting Strategies of Antenatal Balanced Energy and Protein Supplementation in Addis Ababa, Ethiopia
1 other identifier
interventional
6,750
1 country
1
Brief Summary
The goal of this randomized effectiveness study is to evaluate the different targeting strategies for the delivery of balanced energy and protein (BEP) supplements among pregnant women in Addis Ababa, Ethiopia. The main goals of the study are to: 1) determine the effectiveness of two individual-based antenatal BEP targeting strategies for preventing adverse pregnancy outcomes; 2) compare the cost-effectiveness of the universal BEP provision with two individual-based targeting strategies for preventing adverse pregnancy outcomes; and 3) generate implementation evidence regarding the feasibility and acceptability of different antenatal BEP targeting strategies. Pregnant women will be enrolled during pregnancy, assigned to different strategies of BEP supplementation, and followed from pregnancy through six weeks postpartum to evaluate the impacts of different BEP targeting strategies on pregnancy, maternal, and child outcomes.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Aug 2023
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 7, 2023
CompletedFirst Submitted
Initial submission to the registry
October 31, 2023
CompletedFirst Posted
Study publicly available on registry
November 9, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 31, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
July 31, 2026
December 19, 2025
January 1, 2025
3 years
October 31, 2023
December 12, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Small-for-gestational-age births
Live birth whose birthweight for sex and gestational age is \< 10th percentile based on the INTERGROWTH-21st standards
Assessed within 72 hours of birth
Secondary Outcomes (11)
Inadequate gestational weight gain
At the last weight measurement before delivery, at around 36 weeks
Excessive gestational weight gain
At the last weight measurement before delivery, at around 36 weeks
Stillbirth
Between 28 weeks of gestation and delivery
Preterm birth
Less than 37 completed weeks of gestation
Low birthweight
Assessed within 72 hours of birth
- +6 more secondary outcomes
Study Arms (4)
Arm 1 (control arm)
NO INTERVENTIONIn Arm 1 (control arm), participants will receive the standard of antenatal care including iron and folic acid supplementation.
Arm 2 (Targeted BEP based on baseline nutritional status)
EXPERIMENTALArm 3 (Targeted BEP by baseline nutritional status and monthly gestational weight gain monitoring)
EXPERIMENTALArm 4 (universal BEP)
EXPERIMENTALInterventions
In Arm 4 (universal BEP), all participants will receive BEP supplements from baseline through the end of pregnancy.
In Arm 3 (targeted BEP based on baseline nutritional status and monthly GWG monitoring), in addition to the standard of care, participants will receive BEP supplements if their baseline BMI is less than 18.5 or their baseline mid-upper arm circumference is less than 23 cm; participants with an inadequate GWG at a monthly follow-up visit will receive additional BEP supplements.
In Arm 2 (targeted BEP based on baseline nutritional status), in addition to the standard of care, participants will receive BEP supplements if their baseline BMI is less than 18.5 or their baseline mid-upper arm circumference is less than 23 cm.
Eligibility Criteria
You may qualify if:
- pregnant women aged 18 to 49;
- attending antenatal visits in one of the study health facilities;
- with a gestational age of 24 weeks or less;
- no known allergies to peanuts or soybeans;
- having resided in the current location for at least 6 months;
- intending to continue antenatal follow-up in the health facility;
- intending to give birth and remain in the study area until six weeks after delivery; and
- willing to take the BEP supplements for the entire duration of the pregnancy if eligible.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Addis Continental Institute of Public Healthcollaborator
- George Mason Universitycollaborator
- Harvard School of Public Health (HSPH)lead
Study Sites (1)
Addis Continental Institute of Public Health (ACIPH)
Addis Ababa, Addis Ababa, Box 26751/1000, Ethiopia
Related Publications (1)
Wang D, Shifraw T, Costa JC, Abdelmenan S, Tsegaye S, Berhane Y, Gulema H, Berhane H, Fasil N, Workneh F, Tarekegn W, Wang M, Menzies NA, Worku A, Berhane Y, Fawzi WW. Targeting strategies of antenatal balanced energy and protein supplementation in Addis Ababa, Ethiopia: study protocol for a randomized effectiveness study. Trials. 2024 Apr 30;25(1):291. doi: 10.1186/s13063-024-08002-2.
PMID: 38689304DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Wafaie W Fawzi, DrPH, MBBS
Harvard School of Public Health (HSPH)
- PRINCIPAL INVESTIGATOR
Yemane Berhane, MD, PhD
Addis Continental Institute of Public Health
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Richard Saltonstall Professor of Population Sciences, and Professor of Nutrition, Epidemiology, and Global Health
Study Record Dates
First Submitted
October 31, 2023
First Posted
November 9, 2023
Study Start
August 7, 2023
Primary Completion (Estimated)
July 31, 2026
Study Completion (Estimated)
July 31, 2026
Last Updated
December 19, 2025
Record last verified: 2025-01
Data Sharing
- IPD Sharing
- Will not share