Ignite Creation Date:
2025-12-24 @ 2:33 PM
Ignite Modification Date:
2026-01-04 @ 2:50 PM
Study NCT ID:
NCT03578159
Status:
COMPLETED
Last Update Posted:
2018-07-06
First Post:
2018-06-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study of Arsha Vidya Chhatralaya Initiative on Health and Functioning of Disadvantaged Tribal Children
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D044342', 'term': 'Malnutrition'}], 'ancestors': [{'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 50}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-03-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-06', 'completionDateStruct': {'date': '2018-06-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-06-24', 'studyFirstSubmitDate': '2018-06-24', 'studyFirstSubmitQcDate': '2018-06-24', 'lastUpdatePostDateStruct': {'date': '2018-07-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-07-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-05-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Physical health and wellbeing', 'timeFrame': 'Change from baseline to one year', 'description': 'Measured by MacArthur Health and Behavior Questionnaire'}, {'measure': 'Mental Health and wellbeing', 'timeFrame': 'Change from baseline to one year', 'description': 'Measured by MacArthur Health and Behavior Questionnaire'}, {'measure': 'Social functioning', 'timeFrame': 'Change from baseline to one year', 'description': 'Measured by MacArthur Health and Behavior Questionnaire'}, {'measure': 'Academic functioning', 'timeFrame': 'Change from baseline to one year', 'description': 'Measured by MacArthur Health and Behavior Questionnaire'}], 'secondaryOutcomes': [{'measure': 'Weight', 'timeFrame': 'Change from baseline to one year', 'description': "child's weight was measured by using a calibrated electronic weighing scale"}, {'measure': 'Prevalence of acute child malnutrition', 'timeFrame': 'Change from baseline to one year', 'description': 'To calculate WHZ scores the 2006 WHO growth reference was used'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Physical Disorder', 'Mental Health Wellness', 'Social Function Disorder, Childhood or Adolescent', 'Malnutrition']}, 'descriptionModule': {'briefSummary': "India's poor tribal communities have far worse health and social indicators than the general population. Most tribal people live in remote forested or desert areas where illiteracy, trying physical environments, malnutrition, inadequate access to potable water, and lack of personal hygiene and sanitation make them more vulnerable to disease.The aim of Chhatralaya initiatives taken by Arsha Vidya, Jaipur was to address the exclusion of the socially and economically disadvantaged children of the tribes and to provide a fair opportunity to all."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '16 Years', 'minimumAge': '8 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Children selected from Udaipur tribal areas, Rajasthan, India', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Children selected from Udaipur tribal areas as lacking parental care and basic services;\n* Children living in Udaipur tribal areas;\n* Children from 8 years to 16 years of age\n\nExclusion Criteria:'}, 'identificationModule': {'nctId': 'NCT03578159', 'briefTitle': 'Study of Arsha Vidya Chhatralaya Initiative on Health and Functioning of Disadvantaged Tribal Children', 'organization': {'class': 'OTHER', 'fullName': 'NMP Medical Research Institute'}, 'officialTitle': 'Study of Arsha Vidya Chhatralaya Initiative on Health and Functioning of Disadvantaged Tribal Children', 'orgStudyIdInfo': {'id': 'NMP/10128'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Arsha Vidya Chhatralaya', 'description': 'Chhatralaya is residential setting for children 8 to 16 years old. It provides residence,food and education opportunities along with regular practice of Yoga, Spiritual sessions and vedic practices to learn and follow.', 'interventionNames': ['Other: Chhatralaya']}], 'interventions': [{'name': 'Chhatralaya', 'type': 'OTHER', 'description': 'Chhatralaya, home for children provide living resources along with spiritual practices.', 'armGroupLabels': ['Arsha Vidya Chhatralaya']}]}, 'contactsLocationsModule': {'locations': [{'zip': '302019', 'city': 'Jaipur', 'state': 'Rajasthan', 'country': 'India', 'facility': 'Arsha Vidya Chhatralaya,', 'geoPoint': {'lat': 26.91962, 'lon': 75.78781}}], 'overallOfficials': [{'name': 'Brahmaparananda Saraswati', 'role': 'STUDY_CHAIR', 'affiliation': 'Arsha Vidya Tirtha'}, {'name': 'Neha Sharma, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Warwick Research Servives, UK'}, {'name': 'Puneet Sharma', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'NMP Medical Research Institute'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'NMP Medical Research Institute', 'class': 'OTHER'}, 'collaborators': [{'name': 'Warwick Research Services', 'class': 'OTHER'}, {'name': 'Arsha Vidya Tirtha', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}