BEP Targeting Strategies in Ethiopia

Last updated: January 13, 2025
Sponsor: Harvard School of Public Health (HSPH)
Overall Status: Active - Recruiting

Phase

N/A

Condition

Pregnancy

Obesity

Miscarriage

Treatment

Targeted BEP based on baseline nutritional status

Targeted BEP based on baseline nutritional status and monthly GWG monitoring

Universal BEP

Clinical Study ID

NCT06125860
IRB22-1245
  • Ages 18-49
  • Female

Study 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.

Eligibility Criteria

Inclusion

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 ifeligible.

Exclusion

Exclusion Criteria:

  • Not meeting all of the inclusion criteria above

Study Design

Total Participants: 6750
Treatment Group(s): 3
Primary Treatment: Targeted BEP based on baseline nutritional status
Phase:
Study Start date:
August 07, 2023
Estimated Completion Date:
November 30, 2025

Connect with a study center

  • Addis Continental Institute of Public Health (ACIPH)

    Addis Ababa, Box 26751/1000
    Ethiopia

    Active - Recruiting

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