BEP Targeting Strategies in Ethiopia (BEP)

Targeting Strategies of Antenatal Balanced Energy and Protein Supplementation in Addis Ababa, Ethiopia

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Preterm Birth; Birth Weight; Perinatal Death; Gestational Weight Gain; Stillbirth; Neonatal Death; Small for Gestational Age at Delivery; Maternal Anemia in Pregnancy, Before Birth
• Intervention / Treatment: Dietary supplement: Targeted BEP based on baseline nutritional status; Dietary supplement: Targeted BEP based on baseline nutritional status and monthly GWG monitoring; Dietary supplement: Universal BEP

• Study Type: Interventional
• Enrollment (Estimated): 6750
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Ethiopia
  • Addis Ababa
    • Addis Ababa, Addis Ababa, Ethiopia, Box 26751/1000
      • Addis Continental Institute of Public Health (ACIPH)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. pregnant women aged 18 to 49;
2. attending antenatal visits in one of the study health facilities;
3. with a gestational age of 24 weeks or less;
4. no known allergies to peanuts or soybeans;
5. having resided in the current location for at least 6 months;
6. intending to continue antenatal follow-up in the health facility;
7. intending to give birth and remain in the study area until six weeks after delivery; and
8. willing to take the BEP supplements for the entire duration of the pregnancy if eligible.

Exclusion Criteria:

• Not meeting all of the inclusion criteria above

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Arm 1 (control arm); In Arm 1 (control arm), participants will receive the standard of antenatal care including iron and folic acid supplementation.
Experimental: Arm 2 (Targeted BEP based on baseline nutritional status)	Dietary supplement: Targeted BEP based on baseline nutritional status; 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.
Experimental: Arm 3 (Targeted BEP by baseline nutritional status and monthly gestational weight gain monitoring)	Dietary supplement: Targeted BEP based on baseline nutritional status and monthly GWG monitoring; 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.
Experimental: Arm 4 (universal BEP)	Dietary supplement: Universal BEP; In Arm 4 (universal BEP), all participants will receive BEP supplements from baseline through the end of pregnancy.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Inadequate gestational weight gain	Gestational weight gain percent adequacy ratio less than 90% at the last weight measurement before delivery, based on the Institute of Medicine recommendations	At the last weight measurement before delivery, at around 36 weeks
Excessive gestational weight gain	Gestational weight gain percent adequacy ratio greater than 125% at the last weight measurement before delivery, based on the Institute of Medicine recommendations	At the last weight measurement before delivery, at around 36 weeks
Stillbirth	Fetal death between 28 weeks of gestation and delivery	Between 28 weeks of gestation and delivery
Preterm birth	Live birth < 37 completed weeks of gestation	Less than 37 completed weeks of gestation
Low birthweight	Live birth weighing < 2500 grams	Assessed within 72 hours of birth
Macrosomia	Live birth weighing > 4000 grams	Assessed within 72 hours of birth
Large-for-gestational-age births	Live birth whose birthweight for sex and gestational age is > 90th percentile based on the INTERGROWTH-21st standards	Assessed within 72 hours of birth
Third-trimester anemia	Hemoglobin concentration < 11 g/dL at 32 weeks of gestation	At 32 weeks of gestation
Neonatal death	Death of live newborn < 28 days of life	From birth through 28 days of life
Perinatal death	Fetal death between 28 weeks gestational age and delivery, or newborn death < 7 days of life	Between 28 weeks of gestation to 7 days after delivery
Pre-eclampsia	New onset hypertension (systolic blood pressure >= 140 or diastolic blood pressure >=90 mmhg) after 20 weeks of gestation with proteinuria.	After 20 weeks of gestation

Collaborators and Investigators

• Sponsor: Harvard School of Public Health (HSPH)
• Collaborators: Addis Continental Institute of Public Health; George Mason University
• Investigators: 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

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): August 7, 2023
• Primary Completion (Estimated): May 31, 2026
• Study Completion (Estimated): July 31, 2026

Study Registration Dates

• First Submitted: October 31, 2023
• First Submitted That Met QC Criteria: November 5, 2023
• First Posted (Actual): November 9, 2023

Study Record Updates

• Last Update Posted (Actual): May 18, 2026
• Last Update Submitted That Met QC Criteria: May 14, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: Ethiopia; gestational weight gain; food supplementation; maternal nutrition; balanced energy and protein supplementation; antenatal nutrition
• Additional Relevant MeSH Terms: Urogenital Diseases; Pathologic Processes; Female Urogenital Diseases and Pregnancy Complications; Body Weight; Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Body Weight Changes; Death; Fetal Death; Weight Gain; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Gestational Weight Gain; Premature Birth; Birth Weight; Stillbirth; Perinatal Death
• Other Study ID Numbers: IRB22-1245

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No