BEP Targeting Strategies in Ethiopia

President and Fellows of Harvard College

Status: Enrolling

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

Treatments: Dietary Supplement: Targeted BEP based on baseline nutritional status; Dietary Supplement: Universal BEP; Dietary Supplement: Targeted BEP based on baseline nutritional status and monthly GWG monitoring

Study type: Interventional

Funder types: Other

Identifiers

NCT06125860

IRB22-1245

Details and patient eligibility

About

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.

Enrollment: 6,750 estimated patients

Sex: Female

Ages: 18 to 49 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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6,750 participants in 4 patient groups

Arm 1 (control arm)

No Intervention group

Description:

In 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)

Experimental group

Treatment:

Dietary Supplement: Targeted BEP based on baseline nutritional status

Arm 3 (Targeted BEP by baseline nutritional status and monthly gestational weight gain monitoring)

Experimental group

Treatment:

Dietary Supplement: Targeted BEP based on baseline nutritional status and monthly GWG monitoring

Arm 4 (universal BEP)

Experimental group

Treatment:

Dietary Supplement: Universal BEP