Ignite Creation Date:
2025-12-25 @ 2:11 AM
Ignite Modification Date:
2026-02-22 @ 4:53 PM
Study NCT ID:
NCT02136160
Status:
COMPLETED
Last Update Posted:
2023-12-11
First Post:
2014-05-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Population-based Intervention to Promote Health in Elementary Schools
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D000079402', 'term': 'National Program of Cancer Registries'}], 'ancestors': [{'id': 'D002487', 'term': 'Centers for Disease Control and Prevention, U.S.'}, {'id': 'D014492', 'term': 'United States Public Health Service'}, {'id': 'D014483', 'term': 'United States Dept. of Health and Human Services'}, {'id': 'D037041', 'term': 'United States Government Agencies'}, {'id': 'D035082', 'term': 'Federal Government'}, {'id': 'D006076', 'term': 'Government'}, {'id': 'D009938', 'term': 'Organizations'}, {'id': 'D004472', 'term': 'Health Care Economics and Organizations'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 249}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-12', 'lastUpdateSubmitDate': '2023-12-08', 'studyFirstSubmitDate': '2014-05-05', 'studyFirstSubmitQcDate': '2014-05-08', 'lastUpdatePostDateStruct': {'date': '2023-12-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-05-12', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change of health related behaviour due to intervention', 'timeFrame': 'After 6 weeks of intervention period'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['elementary school', 'children', 'health promotion', 'teachers', 'prevention'], 'conditions': ['Health Promotion']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://rakuns.de', 'label': 'project website'}]}, 'descriptionModule': {'briefSummary': 'Population based intervention at elementary school setting aimed at contributing, to a major extent, to health education and health promotion for children aged approximately 5-10 years in Germany. Health education units with theoretical and practical exercises for use by teachers, children, and parents addresses physical activity, sedentary behavior, relaxation, nutrition, personal hygiene and body awareness.\n\nMain questions of the pilot are:\n\nDoes health promotion take on an important role in primary schools? How do teachers evaluate training materials, homepage, content and framework conditions? How do teachers assess the efficiency of teaching units?', 'detailedDescription': 'The program is based on actual cognitions and methods of the early education science. In the pilot phase study part (3/2013-5/2013) the investigators evaluated 210 classes of five states in Germany: NRW, Thüringen, Berlin, Sachsen-Anhalt, Schleswig-Holstein.\n\nThe long-term aim of this project is to provide an innovative concept based on current concepts in social studies and science that addresses health education of pupils in elementary schools.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* teacher of intervention-school\n\nExclusion Criteria:\n\n* absence of consent to participate'}, 'identificationModule': {'nctId': 'NCT02136160', 'briefTitle': 'Population-based Intervention to Promote Health in Elementary Schools', 'organization': {'class': 'OTHER', 'fullName': 'Ludwig-Maximilians - University of Munich'}, 'officialTitle': 'Rakuns: Setting-based Prevention Program to Promote Positive Experiences in Health Promoting Lifestyle Choices', 'orgStudyIdInfo': {'id': 'Rakuns'}}, 'armsInterventionsModule': {'interventions': [{'name': 'attitude change, behavioral change', 'type': 'BEHAVIORAL'}, {'name': 'prevention program', 'type': 'BEHAVIORAL'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ludwig-Maximilians - University of Munich', 'class': 'OTHER'}, 'collaborators': [{'name': 'Child Health Foundation', 'class': 'OTHER'}, {'name': 'Johnson & Johnson Citizenship Trust, in cooperation with Johnson & Johnson GmbHInitiative Rückenwirbel e.V., Gmund', 'class': 'UNKNOWN'}, {'name': 'Platform for Diet and Physical activity e.V. (peb)', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Berthold Koletzko, M.D., Professor of Paediatrics, Dr. von Hauner Children´s Hospital, Ludwig-Maximilians-University, Munich, Germany', 'investigatorFullName': 'Prof. Berthold Koletzko', 'investigatorAffiliation': 'Ludwig-Maximilians - University of Munich'}}}}