Ignite Creation Date:
2025-12-24 @ 9:28 PM
Ignite Modification Date:
2025-12-25 @ 7:14 PM
Study NCT ID:
NCT07158632
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-09-09
First Post:
2025-08-22
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effects of Multiple Interventions on Under-Five Diarrhea
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003967', 'term': 'Diarrhea'}], 'ancestors': [{'id': 'D012817', 'term': 'Signs and Symptoms, Digestive'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'FACTORIAL', 'interventionModelDescription': 'The study contains four arms; these are handwashing education arm, water chlorination arm, combination arm, and control arm'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 840}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-09-08', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2025-12-24', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-09-06', 'studyFirstSubmitDate': '2025-08-22', 'studyFirstSubmitQcDate': '2025-09-02', 'lastUpdatePostDateStruct': {'date': '2025-09-09', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-09-08', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2025-12-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence of diarrhea among under-five children', 'timeFrame': 'At baseline and to four-month follow-up'}], 'secondaryOutcomes': [{'measure': 'Adherence of interventions', 'timeFrame': 'Up to four-month follow-up', 'description': 'percentage of soap availability near toilet and residual chlorine in drinking water'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['central Ethiopia, Diarrhea, Ethiopia, Multiple Interventions'], 'conditions': ['Diarrheal Diseases']}, 'referencesModule': {'references': [{'type': 'BACKGROUND', 'citation': 'Breastfeeding and protection against diarrhea: an integrative review of literature Aleitamento materno e proteção contra diarreia: revisão integrativa da literatura Floriacy Stabnow Santos1 , Felipe César Stabnow Santos2 Adriana Moraes Leite1 , Leonardo Hunaldo dos Santos3 , Débora Falleiros de Mello1'}]}, 'descriptionModule': {'briefSummary': 'Diarrhea is the leading cause of death, especially in developed nations. Though there are effective interventions, diarrhea remains the leading cause of death among children in Ethiopia', 'detailedDescription': 'Diarrheal disease is the major cause of child morbidity and mortality in low-income countries, including Ethiopia. Diarrhea is more common in areas with a lack of water sanitation and hygiene. Even though there are available effective interventions, diarrhea remains the major cause of child morbidity and mortality in Ethiopia. Therefore, the aim of this study is to give up-to-date information on multiple interventions that reduce diarrheal disease.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '59 Months', 'minimumAge': '6 Months', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria\n\n* a child age from 6 to 59 months Exclusion Criteria\n* severely ill mother, households that receive treated water'}, 'identificationModule': {'nctId': 'NCT07158632', 'briefTitle': 'Effects of Multiple Interventions on Under-Five Diarrhea', 'organization': {'class': 'OTHER', 'fullName': 'Jimma University'}, 'officialTitle': 'Effects of Maternal Handwashing Education and Household Water Chlorination on Diarrheal Disease Among Under-Five Children in Central Ethiopia Using RCT', 'orgStudyIdInfo': {'id': 'JUIH/IRB/0509/25'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'handwashing education only arm', 'description': 'Arm A: This arm receives handwashing education.', 'interventionNames': ['Behavioral: handwashing education']}, {'type': 'EXPERIMENTAL', 'label': 'water chlorination only arm', 'description': 'Arm B: This arm receives household water chlorination', 'interventionNames': ['Behavioral: water chlorination']}, {'type': 'EXPERIMENTAL', 'label': 'combined hand washing and water chlorination arm', 'description': 'Arm C: This arm receives both handwashing education and water chlorination.', 'interventionNames': ['Behavioral: combined intervention']}, {'type': 'NO_INTERVENTION', 'label': 'No intervention arm', 'description': 'This arm have not receive any intervention'}], 'interventions': [{'name': 'handwashing education', 'type': 'BEHAVIORAL', 'description': 'Arm A: This arm receive handwashing education using social and behavioral change communication', 'armGroupLabels': ['handwashing education only arm']}, {'name': 'water chlorination', 'type': 'BEHAVIORAL', 'description': 'Arm B: This arm receives water chlorination intervention', 'armGroupLabels': ['water chlorination only arm']}, {'name': 'combined intervention', 'type': 'BEHAVIORAL', 'description': 'Arm C: This arm receives combined handwashing and water chlorination intervention', 'armGroupLabels': ['combined hand washing and water chlorination arm']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Butajīra', 'country': 'Ethiopia', 'facility': 'Butajira Health Center', 'geoPoint': {'lat': 8.11667, 'lon': 38.36667}}], 'centralContacts': [{'name': 'Melaku Tesfaye PhD Candidate, MPH', 'role': 'CONTACT', 'email': 'tesfayemelaku96@gmail.com=', 'phone': '+251916141771'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Jimma University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'PhD Candidate', 'investigatorFullName': 'Melaku Tesfaye', 'investigatorAffiliation': 'Jimma University'}}}}