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

Status: Recruiting
Location: See location...
Intervention Type: Dietary supplement
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: Female
Minimum Age: 18
Maximum Age: 49
Healthy Volunteers: f
View:

• pregnant women aged 18 to 49;

• attending antenatal visits in one of the study health facilities;

• with a gestational age of 24 weeks or less;

• no known allergies to peanuts or soybeans;

• having resided in the current location for at least 6 months;

• intending to continue antenatal follow-up in the health facility;

• intending to give birth and remain in the study area until six weeks after delivery; and

• willing to take the BEP supplements for the entire duration of the pregnancy if eligible.

Locations
Other Locations
Ethiopia
Addis Continental Institute of Public Health (ACIPH)
RECRUITING
Addis Ababa
Contact Information
Primary
Wafaie W Fawzi, DrPH, MBBS
mina@hsph.harvard.edu
617-432-7598
Time Frame
Start Date: 2023-08-07
Estimated Completion Date: 2025-11-30
Participants
Target number of participants: 6750
Treatments
No_intervention: Arm 1 (control arm)
In Arm 1 (control arm), participants will receive the standard of antenatal care including iron and folic acid supplementation.
Experimental: Arm 2 (Targeted BEP based on baseline nutritional status)
Experimental: Arm 3 (Targeted BEP by baseline nutritional status and monthly gestational weight gain monitoring)
Experimental: Arm 4 (universal BEP)
Related Therapeutic Areas
Sponsors
Collaborators: Addis Continental Institute of Public Health, George Mason University
Leads: Harvard School of Public Health (HSPH)

This content was sourced from clinicaltrials.gov