BEP Targeting Strategies in Ethiopia

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

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.

Sponsors & Collaborators

• Addis Continental Institute of Public Health

  collaborator OTHER

• George Mason University

  collaborator OTHER

• Harvard School of Public Health (HSPH)

  lead OTHER

Principal Investigators

• Wafaie W Fawzi, DrPH, MBBS · Harvard School of Public Health (HSPH)

• Yemane Berhane, MD, PhD · Addis Continental Institute of Public Health

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

49 Years

Sex

FEMALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2023-08-07

Primary Completion

2026-05-31

Completion

2026-07-31

Countries

• Ethiopia

Study Locations