BEP Targeting Strategies in Ethiopia
Study Details
Study Description
Brief 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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| 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)
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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.
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| Experimental: Arm 3 (Targeted BEP by baseline nutritional status and monthly gestational weight gain monitoring)
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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.
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| Experimental: Arm 4 (universal BEP)
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Dietary Supplement: Universal BEP
In Arm 4 (universal BEP), all participants will receive BEP supplements from baseline through the end of pregnancy.
|
Outcome Measures
Primary Outcome Measures
- Small-for-gestational-age births [Assessed within 72 hours of birth]
Live birth whose birthweight for sex and gestational age is < 10th percentile based on the INTERGROWTH-21st standards
Secondary Outcome Measures
- Inadequate gestational weight gain [At the last weight measurement before delivery, at around 36 weeks]
Gestational weight gain percent adequacy ratio less than 90% at the last weight measurement before delivery, based on the Institute of Medicine recommendations
- Excessive gestational weight gain [At the last weight measurement before delivery, at around 36 weeks]
Gestational weight gain percent adequacy ratio greater than 125% at the last weight measurement before delivery, based on the Institute of Medicine recommendations
- Stillbirth [Between 28 weeks of gestation and delivery]
Fetal death between 28 weeks of gestation and delivery
- Preterm birth [Less than 37 completed weeks of gestation]
Live birth < 37 completed weeks of gestation
- Low birthweight [Assessed within 72 hours of birth]
Live birth weighing < 2500 grams
- Macrosomia [Assessed within 72 hours of birth]
Live birth weighing > 4000 grams
- Large-for-gestational-age births [Assessed within 72 hours of birth]
Live birth whose birthweight for sex and gestational age is > 90th percentile based on the INTERGROWTH-21st standards
- Third-trimester anemia [At 32 weeks of gestation]
Hemoglobin concentration < 11 g/dL at 32 weeks of gestation
- Neonatal death [From birth through 28 days of life]
Death of live newborn < 28 days of life
- Perinatal death [Between 28 weeks of gestation to 7 days after delivery]
Fetal death between 28 weeks gestational age and delivery, or newborn death < 7 days of life
- Pre-eclampsia [After 20 weeks of gestation]
New onset hypertension (systolic blood pressure >= 140 or diastolic blood pressure >=90 mmhg) after 20 weeks of gestation with proteinuria.
Eligibility Criteria
Criteria
Inclusion Criteria:
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pregnant women aged 18 to 49;
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attending antenatal visits in one of the study health facilities;
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with a gestational age of 24 weeks or less;
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no known allergies to peanuts or soybeans;
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having resided in the current location for at least 12 months;
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intending to continue antenatal follow-up in the health facility;
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intending to give birth and remain in the study area until six weeks after delivery; and
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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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Addis Continental Institute of Public Health (ACIPH) | Addis Ababa | Ethiopia | Box 26751/1000 |
Sponsors and Collaborators
- Harvard School of Public Health (HSPH)
- Addis Continental Institute of Public Health
- George Mason University
Investigators
- Principal Investigator: Wafaie W Fawzi, DrPH, MBBS, Harvard School of Public Health (HSPH)
- Principal Investigator: Yemane Berhane, MD, PhD, Addis Continental Institute of Public Health
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- IRB22-1245