Ignite Creation Date:
2025-12-25 @ 3:37 AM
Ignite Modification Date:
2025-12-26 @ 2:21 AM
Study NCT ID:
NCT02903602
Status:
COMPLETED
Last Update Posted:
2016-09-16
First Post:
2016-08-31
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Sharing Histories: Test of a Teaching Method for Community Health Workers
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007228', 'term': 'Infant Nutrition Disorders'}, {'id': 'D015438', 'term': 'Health Behavior'}, {'id': 'D006130', 'term': 'Growth Disorders'}], 'ancestors': [{'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D001519', 'term': 'Behavior'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 600}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-09', 'completionDateStruct': {'date': '2014-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-09-15', 'studyFirstSubmitDate': '2016-08-31', 'studyFirstSubmitQcDate': '2016-09-15', 'lastUpdatePostDateStruct': {'date': '2016-09-16', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-09-16', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in rate of stunting in children under two years of age (birth to 23.9 months of age)', 'timeFrame': 'Chidren born up to 24 months prior to the baseline survey in 2010. Children born up to 24 months prior to the final survey in 2014', 'description': 'Stunting is defined as low height-for-age less than -2 z-scores from the median on the World Health Organization growth standard, 2006.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['sharing histories', 'autobiographical memory', 'health behavior', 'narrative communication', 'community health workers', 'global health', 'maternal and child health', 'stunting'], 'conditions': ['Infant Nutrition Disorders', 'Health Behavior']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine the effectiveness of an innovative methodology for training Community Health Workers that will improve their effectiveness in educating mothers to adopt best practice health behaviors in the home.', 'detailedDescription': 'Objective: Training of community health workers (CHW) is a growing priority to close the gap between health services and mothers/families in resource poor communities. To address research needs on how to improve effectiveness of CHW training, the investigators tested an innovative CHW teaching methodology called "Sharing Histories" hypothesizing that this would empower and enable CHW to better teach mothers to improve health knowledge and behaviors that contribute to improved child growth.\n\nMethod: The study was a cluster-randomized controlled trial: 22 health facility jurisdictions were matched and randomly assigned as experimental or control. Health personnel Tutors and female CHW were trained using either the "Sharing Histories" methodology (experimental) or a standard but still participatory teaching method (control). Training content, materials, and other interventions were held constant between study groups. Impact on maternal knowledge and practices, and child growth and morbidity were measured in representative household surveys at baseline, midterm, and final evaluation, with 600 mothers interviewed - 300 in each study group - at each point in time.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '23 Months', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult interviewed must be mother or guardian of a child under two years of age.\n* Child from birth (0.1 months-old) to under two years of age (23.9 months-old).\n\nExclusion Criteria:\n\n* If a mother selected for interview had more than one child under age two years, only the younger child was considered for the interview and anthropometry measurements.'}, 'identificationModule': {'nctId': 'NCT02903602', 'briefTitle': 'Sharing Histories: Test of a Teaching Method for Community Health Workers', 'organization': {'class': 'OTHER', 'fullName': 'Future Generations Graduate School'}, 'officialTitle': 'Health in the Hands of Women: Test of a Community Health Worker Teaching Method "Sharing Histories"', 'orgStudyIdInfo': {'id': 'FGGS-01'}, 'secondaryIdInfos': [{'id': 'N° AID-OAA-A-10-00048', 'type': 'OTHER_GRANT', 'domain': 'US Agency for International Development (USAID)'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'CHW training method-Sharing Histories', 'description': 'Experimental clusters of primary health care facilities provided training to Community Health Workers (CHW) from their communities utilizing the experimental teaching methodology, "Sharing Histories".\n\nCHW in both study groups made home visits to pregnant women and mothers of children under two years of age to teach mothers, monitor behaviors and danger signs in pregnant women, newborns, and children, and refer cases when needed for preventive and curative care.', 'interventionNames': ['Behavioral: Sharing Histories training method for CHW']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'CHW training method-Standard', 'description': 'Control clusters of primary health care facilities provided training to Community Health Workers (CHW) from their communities utilizing a standard CHW teaching methodology.\n\nCHW in both study groups made home visits to pregnant women and mothers of children under two years of age to teach mothers, monitor behaviors and danger signs in pregnant women, newborns, and children, and refer cases when needed for preventive and curative care.', 'interventionNames': ['Behavioral: Standard training method for CHW']}], 'interventions': [{'name': 'Sharing Histories training method for CHW', 'type': 'BEHAVIORAL', 'description': 'Female Community Health Worker training participants were led through a guided process of recalling and sharing their autobiographical memories of their personal experiences in the first 1000 days of each of their children (pregnancy, childbirth, postpartum, newborn, breastfeeding, complementary feeding, infant diarrhea and hygiene, pneumonia). On the basis of memories, cultural beliefs and practices are identified and training content is built.', 'armGroupLabels': ['CHW training method-Sharing Histories']}, {'name': 'Standard training method for CHW', 'type': 'BEHAVIORAL', 'description': 'Female Community Health Workers were trained with standard participatory teaching method with three phases: identify knowledge, provide new knowledge, evaluate learning.', 'armGroupLabels': ['CHW training method-Standard']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Laura C. Altobelli, DrPH', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Future Generations Graduate School'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES', 'description': 'Data set available to researchers by contacting Principal Investigator'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Future Generations Graduate School', 'class': 'OTHER'}, 'collaborators': [{'name': 'United States Agency for International Development (USAID)', 'class': 'FED'}, {'name': 'Instituto de Investigacion Nutricional, Peru', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor - Principal Investigator', 'investigatorFullName': 'Laura C. Altobelli', 'investigatorAffiliation': 'Future Generations Graduate School'}}}}