NCT06125860

BEP Targeting Strategies in Ethiopia

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 6,750 (estimated)
• Sponsor: Harvard School of Public Health (HSPH) · Academic / Other
• Sex: Female
• Age: 18 Years – 49 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Small for Gestational Age at Delivery
• Gestational Weight Gain
• Stillbirth
• Preterm Birth
• Birth Weight
• Maternal Anemia in Pregnancy, Before Birth
• Neonatal Death
• Perinatal Death

Interventions

Type	Name	Description
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.
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.
DIETARY_SUPPLEMENT	Universal BEP	In Arm 4 (universal BEP), all participants will receive BEP supplements from baseline through the end of pregnancy.

Timeline

• Start date: 2023-08-07
• Primary completion: 2026-07-31
• Completion: 2026-07-31
• First posted: 2023-11-09
• Last updated: 2025-12-19

Locations

1 site across 1 country: Ethiopia