Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
6750 participants
INTERVENTIONAL
2023-08-07
2026-07-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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Arm 1 (control arm)
In Arm 1 (control arm), participants will receive the standard of antenatal care including iron and folic acid supplementation.
No interventions assigned to this group
Arm 2 (Targeted BEP based on baseline nutritional status)
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.
Arm 3 (Targeted BEP by baseline nutritional status and monthly gestational weight gain monitoring)
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.
Arm 4 (universal BEP)
Universal BEP
In Arm 4 (universal BEP), all participants will receive BEP supplements from baseline through the end of pregnancy.
Interventions
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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.
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.
Universal BEP
In Arm 4 (universal BEP), all participants will receive BEP supplements from baseline through the end of pregnancy.
Eligibility Criteria
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Inclusion Criteria
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.
18 Years
49 Years
FEMALE
No
Sponsors
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Addis Continental Institute of Public Health
OTHER
George Mason University
OTHER
Harvard School of Public Health (HSPH)
OTHER
Responsible Party
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Wafaie Fawzi
Richard Saltonstall Professor of Population Sciences, and Professor of Nutrition, Epidemiology, and Global Health
Principal Investigators
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Wafaie W Fawzi, DrPH, MBBS
Role: PRINCIPAL_INVESTIGATOR
Harvard School of Public Health (HSPH)
Yemane Berhane, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Addis Continental Institute of Public Health
Locations
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Addis Continental Institute of Public Health (ACIPH)
Addis Ababa, Addis Ababa, Ethiopia
Countries
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Central Contacts
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Facility Contacts
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Yemane Berhane, MD, PhD
Role: primary
References
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Wang D, Shifraw T, Costa JC, Abdelmenan S, Tsegaye S, Berhane Y, Gulema H, Berhane H, Fasil N, Workneh F, Tarekegn W, Wang M, Menzies NA, Worku A, Berhane Y, Fawzi WW. Targeting strategies of antenatal balanced energy and protein supplementation in Addis Ababa, Ethiopia: study protocol for a randomized effectiveness study. Trials. 2024 Apr 30;25(1):291. doi: 10.1186/s13063-024-08002-2.
Other Identifiers
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IRB22-1245
Identifier Type: -
Identifier Source: org_study_id