Ignite Creation Date:
2025-12-25 @ 2:11 AM
Ignite Modification Date:
2025-12-27 @ 1:03 PM
Study NCT ID:
NCT06125860
Status:
RECRUITING
Last Update Posted:
2025-12-19
First Post:
2023-10-31
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
BEP Targeting Strategies in Ethiopia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000078064', 'term': 'Gestational Weight Gain'}, {'id': 'D050497', 'term': 'Stillbirth'}, {'id': 'D047928', 'term': 'Premature Birth'}, {'id': 'D001724', 'term': 'Birth Weight'}, {'id': 'D066087', 'term': 'Perinatal Death'}], 'ancestors': [{'id': 'D015430', 'term': 'Weight Gain'}, {'id': 'D001836', 'term': 'Body Weight Changes'}, {'id': 'D001835', 'term': 'Body Weight'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D005313', 'term': 'Fetal Death'}, {'id': 'D011248', 'term': 'Pregnancy Complications'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D003643', 'term': 'Death'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D007752', 'term': 'Obstetric Labor, Premature'}, {'id': 'D007744', 'term': 'Obstetric Labor Complications'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 6750}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-08-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-01', 'completionDateStruct': {'date': '2026-07-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-12', 'studyFirstSubmitDate': '2023-10-31', 'studyFirstSubmitQcDate': '2023-11-05', 'lastUpdatePostDateStruct': {'date': '2025-12-19', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2023-11-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-07-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Small-for-gestational-age births', 'timeFrame': 'Assessed within 72 hours of birth', 'description': 'Live birth whose birthweight for sex and gestational age is \\< 10th percentile based on the INTERGROWTH-21st standards'}], 'secondaryOutcomes': [{'measure': 'Inadequate gestational weight gain', 'timeFrame': 'At the last weight measurement before delivery, at around 36 weeks', 'description': 'Gestational weight gain percent adequacy ratio less than 90% at the last weight measurement before delivery, based on the Institute of Medicine recommendations'}, {'measure': 'Excessive gestational weight gain', 'timeFrame': 'At the last weight measurement before delivery, at around 36 weeks', 'description': 'Gestational weight gain percent adequacy ratio greater than 125% at the last weight measurement before delivery, based on the Institute of Medicine recommendations'}, {'measure': 'Stillbirth', 'timeFrame': 'Between 28 weeks of gestation and delivery', 'description': 'Fetal death between 28 weeks of gestation and delivery'}, {'measure': 'Preterm birth', 'timeFrame': 'Less than 37 completed weeks of gestation', 'description': 'Live birth \\< 37 completed weeks of gestation'}, {'measure': 'Low birthweight', 'timeFrame': 'Assessed within 72 hours of birth', 'description': 'Live birth weighing \\< 2500 grams'}, {'measure': 'Macrosomia', 'timeFrame': 'Assessed within 72 hours of birth', 'description': 'Live birth weighing \\> 4000 grams'}, {'measure': 'Large-for-gestational-age births', 'timeFrame': 'Assessed within 72 hours of birth', 'description': 'Live birth whose birthweight for sex and gestational age is \\> 90th percentile based on the INTERGROWTH-21st standards'}, {'measure': 'Third-trimester anemia', 'timeFrame': 'At 32 weeks of gestation', 'description': 'Hemoglobin concentration \\< 11 g/dL at 32 weeks of gestation'}, {'measure': 'Neonatal death', 'timeFrame': 'From birth through 28 days of life', 'description': 'Death of live newborn \\< 28 days of life'}, {'measure': 'Perinatal death', 'timeFrame': 'Between 28 weeks of gestation to 7 days after delivery', 'description': 'Fetal death between 28 weeks gestational age and delivery, or newborn death \\< 7 days of life'}, {'measure': 'Pre-eclampsia', 'timeFrame': 'After 20 weeks of gestation', 'description': 'New onset hypertension (systolic blood pressure \\>= 140 or diastolic blood pressure \\>=90 mmhg) after 20 weeks of gestation with proteinuria.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['balanced energy and protein supplementation', 'food supplementation', 'antenatal nutrition', 'maternal nutrition', 'gestational weight gain', 'Ethiopia'], 'conditions': ['Small for Gestational Age at Delivery', 'Gestational Weight Gain', 'Stillbirth', 'Preterm Birth', 'Birth Weight', 'Maternal Anemia in Pregnancy, Before Birth', 'Neonatal Death', 'Perinatal Death']}, 'referencesModule': {'references': [{'pmid': '38689304', 'type': 'DERIVED', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '49 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. pregnant women aged 18 to 49;\n2. attending antenatal visits in one of the study health facilities;\n3. with a gestational age of 24 weeks or less;\n4. no known allergies to peanuts or soybeans;\n5. having resided in the current location for at least 6 months;\n6. intending to continue antenatal follow-up in the health facility;\n7. intending to give birth and remain in the study area until six weeks after delivery; and\n8. willing to take the BEP supplements for the entire duration of the pregnancy if eligible.\n\nExclusion Criteria:\n\n* Not meeting all of the inclusion criteria above'}, 'identificationModule': {'nctId': 'NCT06125860', 'acronym': 'BEP', 'briefTitle': 'BEP Targeting Strategies in Ethiopia', 'organization': {'class': 'OTHER', 'fullName': 'Harvard School of Public Health (HSPH)'}, 'officialTitle': 'Targeting Strategies of Antenatal Balanced Energy and Protein Supplementation in Addis Ababa, Ethiopia', 'orgStudyIdInfo': {'id': 'IRB22-1245'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Arm 1 (control arm)', 'description': 'In Arm 1 (control arm), participants will receive the standard of antenatal care including iron and folic acid supplementation.'}, {'type': 'EXPERIMENTAL', 'label': 'Arm 2 (Targeted BEP based on baseline nutritional status)', 'interventionNames': ['Dietary Supplement: Targeted BEP based on baseline nutritional status']}, {'type': 'EXPERIMENTAL', 'label': 'Arm 3 (Targeted BEP by baseline nutritional status and monthly gestational weight gain monitoring)', 'interventionNames': ['Dietary Supplement: Targeted BEP based on baseline nutritional status and monthly GWG monitoring']}, {'type': 'EXPERIMENTAL', 'label': 'Arm 4 (universal BEP)', 'interventionNames': ['Dietary Supplement: Universal BEP']}], 'interventions': [{'name': 'Targeted BEP based on baseline nutritional status', 'type': 'DIETARY_SUPPLEMENT', 'description': '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.', 'armGroupLabels': ['Arm 2 (Targeted BEP based on baseline nutritional status)']}, {'name': 'Targeted BEP based on baseline nutritional status and monthly GWG monitoring', 'type': 'DIETARY_SUPPLEMENT', 'description': '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.', 'armGroupLabels': ['Arm 3 (Targeted BEP by baseline nutritional status and monthly gestational weight gain monitoring)']}, {'name': 'Universal BEP', 'type': 'DIETARY_SUPPLEMENT', 'description': 'In Arm 4 (universal BEP), all participants will receive BEP supplements from baseline through the end of pregnancy.', 'armGroupLabels': ['Arm 4 (universal BEP)']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'Box 26751/1000', 'city': 'Addis Ababa', 'state': 'Addis Ababa', 'status': 'RECRUITING', 'country': 'Ethiopia', 'contacts': [{'name': 'Yemane Berhane, MD, PhD', 'role': 'CONTACT', 'email': 'yemaneberhane@gmail.com', 'phone': '251118965240'}], 'facility': 'Addis Continental Institute of Public Health (ACIPH)', 'geoPoint': {'lat': 9.02497, 'lon': 38.74689}}], 'centralContacts': [{'name': 'Wafaie W Fawzi, DrPH, MBBS', 'role': 'CONTACT', 'email': 'mina@hsph.harvard.edu', 'phone': '617-432-7598'}], 'overallOfficials': [{'name': 'Wafaie W Fawzi, DrPH, MBBS', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Harvard School of Public Health (HSPH)'}, {'name': 'Yemane Berhane, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Addis Continental Institute of Public Health'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Harvard School of Public Health (HSPH)', 'class': 'OTHER'}, 'collaborators': [{'name': 'Addis Continental Institute of Public Health', 'class': 'OTHER'}, {'name': 'George Mason University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Richard Saltonstall Professor of Population Sciences, and Professor of Nutrition, Epidemiology, and Global Health', 'investigatorFullName': 'Wafaie Fawzi', 'investigatorAffiliation': 'Harvard School of Public Health (HSPH)'}}}}