Ignite Creation Date:
2025-12-24 @ 6:40 PM
Ignite Modification Date:
2025-12-24 @ 6:40 PM
Study NCT ID:
NCT03910257
Status:
COMPLETED
Last Update Posted:
2019-09-19
First Post:
2019-04-04
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Nutrition Education Module for Preschooler Children
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'a quasi-experimental research design with pre-and post-test control group design'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 300}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-05-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-09', 'completionDateStruct': {'date': '2019-06-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-09-17', 'studyFirstSubmitDate': '2019-04-04', 'studyFirstSubmitQcDate': '2019-04-08', 'lastUpdatePostDateStruct': {'date': '2019-09-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-04-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-05-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Changes on nutrition related knowledge before and after intevention', 'timeFrame': '3 weeks', 'description': 'a self administered structured questionnaire regarding nutrition related knowledge (my meal plate, fruits and vegetables, healthy snacks) using pictures yielding a total score between 0-100'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Children Who Registered on the Selected Public Kindergarten and Agree to Follow the Study Assigned by Their Parents and Teacher']}, 'descriptionModule': {'briefSummary': 'This study evaluates the knowledge of preschooler children before and after intervention of nutrition education using nutrition education module for preschooler children. The teachers will be given training regarding the module and deliver it in the class during the intervention.', 'detailedDescription': 'A nutrition education module for preschooler children had been developed in the previous study. The module consists of 3 topics of nutrition (my meal plate, fruits and vegetables, healthy snacks). Each topic consists of 4 activities engaging children and teachers. A total of 12 activities will be delivered on 4 consecutive school day every week.\n\nThe teacher will deliver the nutrition education which trained prior to the study.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '7 Years', 'minimumAge': '4 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* children registered in selected public kindergarten\n* grade/class B kindergarten\n* willing to follow the study\n\nExclusion Criteria:\n\n\\-'}, 'identificationModule': {'nctId': 'NCT03910257', 'briefTitle': 'Nutrition Education Module for Preschooler Children', 'organization': {'class': 'OTHER', 'fullName': 'SEAMEO Regional Centre for Food and Nutrition'}, 'officialTitle': 'the Effectiveness of Nutrition Education Module to Knowledge of Preschooler Children in Public Kindergarten at 3 Districts of Riau Province', 'orgStudyIdInfo': {'id': 'modul gizi'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'nutrition education module', 'description': '12 activities of the nutrition education module pre and post test', 'interventionNames': ['Behavioral: nutrition education module']}, {'type': 'NO_INTERVENTION', 'label': 'control group', 'description': 'no intervention pre and post test'}], 'interventions': [{'name': 'nutrition education module', 'type': 'BEHAVIORAL', 'description': '12 activities of nutrition education module will deliver by the teacher. The activities consists of coloring my meal plate, playing pictures, story telling: Zizi and Ziko, pictures station, fruits and vegetables card, cooking class, planting bean sprouts, field visit to fruits and vegetables garden, making collages, dot to dot, watching video, making healthy snacks', 'armGroupLabels': ['nutrition education module']}]}, 'contactsLocationsModule': {'locations': [{'zip': '28294', 'city': 'Pekanbaru', 'state': 'Riau', 'country': 'Indonesia', 'facility': 'TK Negeri Pembina Pekanbaru', 'geoPoint': {'lat': 0.51667, 'lon': 101.44167}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'SEAMEO Regional Centre for Food and Nutrition', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Affiliated Researcher', 'investigatorFullName': 'Muharni Harahap', 'investigatorAffiliation': 'SEAMEO Regional Centre for Food and Nutrition'}}}}