BEP Targeting Strategies in Ethiopia

Study Overview
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Brief Summary
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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
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Targeting Strategies of Antenatal Balanced Energy and Protein Supplementation in Addis Ababa, Ethiopia

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

Intervention / Treatment
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* Dietary Supplement: Targeted BEP based on baseline nutritional status
* Dietary Supplement: Targeted BEP based on baseline nutritional status and monthly GWG monitoring
* Dietary Supplement: Universal BEP


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 12 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. Exclusion Criteria: Not meeting all of the inclusion criteria above

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 49 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Arm 1 (control arm)<br>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)<br> | Dietary Supplement: Targeted BEP based on baseline nutritional status<br>* 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.<br>|
| Experimental: Arm 3 (Targeted BEP by baseline nutritional status and monthly gestational weight gain monitoring)<br> | Dietary Supplement: Targeted BEP based on baseline nutritional status and monthly GWG monitoring<br>* 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.<br>|
| Experimental: Arm 4 (universal BEP)<br> | Dietary Supplement: Universal BEP<br>* In Arm 4 (universal BEP), all participants will receive BEP supplements from baseline through the end of pregnancy.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Small-for-gestational-age births | Live birth whose birthweight for sex and gestational age is < 10th percentile based on the INTERGROWTH-21st standards | Assessed within 72 hours of birth | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Inadequate gestational weight gain | Gestational weight gain percent adequacy ratio less than 90% at the last weight measurement before delivery, based on the Institute of Medicine recommendations | At the last weight measurement before delivery, at around 36 weeks | 
| Excessive gestational weight gain | Gestational weight gain percent adequacy ratio greater than 125% at the last weight measurement before delivery, based on the Institute of Medicine recommendations | At the last weight measurement before delivery, at around 36 weeks | 
| Stillbirth | Fetal death between 28 weeks of gestation and delivery | Between 28 weeks of gestation and delivery | 
| Preterm birth | Live birth < 37 completed weeks of gestation | Less than 37 completed weeks of gestation | 
| Low birthweight | Live birth weighing < 2500 grams | Assessed within 72 hours of birth | 
| Macrosomia | Live birth weighing > 4000 grams | Assessed within 72 hours of birth | 
| Large-for-gestational-age births | Live birth whose birthweight for sex and gestational age is > 90th percentile based on the INTERGROWTH-21st standards | Assessed within 72 hours of birth | 
| Third-trimester anemia | Hemoglobin concentration < 11 g/dL at 32 weeks of gestation | At 32 weeks of gestation | 
| Neonatal death | Death of live newborn < 28 days of life | From birth through 28 days of life | 
| Perinatal death | Fetal death between 28 weeks gestational age and delivery, or newborn death < 7 days of life | Between 28 weeks of gestation to 7 days after delivery | 
| Pre-eclampsia | New onset hypertension (systolic blood pressure >= 140 or diastolic blood pressure >=90 mmhg) after 20 weeks of gestation with proteinuria. | After 20 weeks of gestation | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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balanced energy and protein supplementation, food supplementation, antenatal nutrition, maternal nutrition, gestational weight gain, Ethiopia