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RECRUITING
NCT06125860
NA

BEP Targeting Strategies in Ethiopia

Sponsor: Harvard School of Public Health (HSPH)

View on ClinicalTrials.gov

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.

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

Key Details

Gender

FEMALE

Age Range

18 Years - 49 Years

Study Type

INTERVENTIONAL

Enrollment

6750

Start Date

2023-08-07

Completion Date

2026-07-31

Last Updated

2025-12-19

Healthy Volunteers

No

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.

Locations (1)

Addis Continental Institute of Public Health (ACIPH)

Addis Ababa, Addis Ababa, Ethiopia