Ignite Creation Date:
2025-12-24 @ 10:40 PM
Ignite Modification Date:
2026-03-12 @ 10:39 AM
Study NCT ID:
NCT01679535
Status:
TERMINATED
Last Update Posted:
2024-03-12
First Post:
2012-08-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Nutrition/Hygiene Education Program for the Prevention of Child Malnutrition in Rural Kenya
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015362', 'term': 'Child Nutrition Disorders'}, {'id': 'D007228', 'term': 'Infant Nutrition Disorders'}, {'id': 'D044342', 'term': 'Malnutrition'}, {'id': 'D011502', 'term': 'Protein-Energy Malnutrition'}], 'ancestors': [{'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D011488', 'term': 'Protein Deficiency'}, {'id': 'D003677', 'term': 'Deficiency Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D009752', 'term': 'Nutritional Status'}], 'ancestors': [{'id': 'D009747', 'term': 'Nutritional Physiological Phenomena'}, {'id': 'D000066888', 'term': 'Diet, Food, and Nutrition'}, {'id': 'D010829', 'term': 'Physiological Phenomena'}, {'id': 'D006304', 'term': 'Health Status'}, {'id': 'D003710', 'term': 'Demography'}, {'id': 'D011154', 'term': 'Population Characteristics'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 246}}, 'statusModule': {'whyStopped': 'Not an applicable clinical trial (ACT).', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2011-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-03', 'completionDateStruct': {'date': '2014-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-03-09', 'studyFirstSubmitDate': '2012-08-29', 'studyFirstSubmitQcDate': '2012-08-31', 'lastUpdatePostDateStruct': {'date': '2024-03-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2012-09-06', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Prevalence of diarrhea', 'timeFrame': 'Prevalence assessed when children reach 24 months of age'}], 'primaryOutcomes': [{'measure': 'malnutrition prevalence', 'timeFrame': 'Measured when children are 24 months of age', 'description': 'Child malnutrition rates, as measured by the prevalence of underweight, wasting, and growth stunting of the children in each group'}], 'secondaryOutcomes': [{'measure': 'Child growth', 'timeFrame': 'Measured when children are 24 months of age', 'description': 'Child growth as measured by change in z score of the children in each group'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Infant nutrition disorder', 'Child nutrition disorders', 'Malnutrition', 'Protein-energy malnutrition'], 'conditions': ['Child Nutrition Disorders']}, 'referencesModule': {'references': [{'pmid': '18207566', 'type': 'RESULT', 'citation': 'Black RE, Allen LH, Bhutta ZA, Caulfield LE, de Onis M, Ezzati M, Mathers C, Rivera J; Maternal and Child Undernutrition Study Group. Maternal and child undernutrition: global and regional exposures and health consequences. Lancet. 2008 Jan 19;371(9608):243-60. doi: 10.1016/S0140-6736(07)61690-0. No abstract available.'}, {'pmid': '18206226', 'type': 'RESULT', 'citation': 'Bhutta ZA, Ahmed T, Black RE, Cousens S, Dewey K, Giugliani E, Haider BA, Kirkwood B, Morris SS, Sachdev HP, Shekar M; Maternal and Child Undernutrition Study Group. What works? Interventions for maternal and child undernutrition and survival. Lancet. 2008 Feb 2;371(9610):417-40. doi: 10.1016/S0140-6736(07)61693-6.'}, {'pmid': '18289157', 'type': 'RESULT', 'citation': 'Dewey KG, Adu-Afarwuah S. Systematic review of the efficacy and effectiveness of complementary feeding interventions in developing countries. Matern Child Nutr. 2008 Apr;4 Suppl 1(Suppl 1):24-85. doi: 10.1111/j.1740-8709.2007.00124.x.'}]}, 'descriptionModule': {'briefSummary': 'This study will determine if an education program about hygiene and child feeding practices, taught by local village community health workers, will improve child growth and decrease the prevalence of childhood malnutrition in a rural region of Kenya.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '6 Months', 'minimumAge': '1 Month', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Child of a mother living in the catchment area of the study who delivered during the enrollment period'}, 'identificationModule': {'nctId': 'NCT01679535', 'briefTitle': 'A Nutrition/Hygiene Education Program for the Prevention of Child Malnutrition in Rural Kenya', 'organization': {'class': 'OTHER', 'fullName': 'University of New Mexico'}, 'officialTitle': 'A Nutrition/Hygiene Education Program for the Prevention of Child Malnutrition in Rural Kenya', 'orgStudyIdInfo': {'id': 'TOMEDI-12-049'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intervention', 'description': 'nutrition and hygiene education by community health workers', 'interventionNames': ['Behavioral: nutrition and hygiene education']}], 'interventions': [{'name': 'nutrition and hygiene education', 'type': 'BEHAVIORAL', 'description': 'Monthly education sessions about child feeding and hygiene for mothers of young children, conducted by local Kenyan community health workers', 'armGroupLabels': ['Intervention']}]}, 'contactsLocationsModule': {'locations': [{'zip': '87131', 'city': 'Albuquerque', 'state': 'New Mexico', 'country': 'United States', 'facility': 'University of New Mexico', 'geoPoint': {'lat': 35.08449, 'lon': -106.65114}}], 'overallOfficials': [{'name': 'Angelo J Tomedi, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of New Mexico'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of New Mexico', 'class': 'OTHER'}, 'collaborators': [{'name': 'University of Nairobi', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}