Ignite Creation Date:
2025-12-24 @ 7:35 PM
Ignite Modification Date:
2026-01-09 @ 5:39 AM
Study NCT ID:
NCT04956003
Status:
UNKNOWN
Last Update Posted:
2023-03-09
First Post:
2021-06-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Optimizing Cardiometabolic Health, Cognition and Academic Performance in Children (HAPHC)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009043', 'term': 'Motor Activity'}], 'ancestors': [{'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 750}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-09-27', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-03', 'completionDateStruct': {'date': '2025-09-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-03-08', 'studyFirstSubmitDate': '2021-06-15', 'studyFirstSubmitQcDate': '2021-06-28', 'lastUpdatePostDateStruct': {'date': '2023-03-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-07-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-10-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Cardiovascular changes - heart rate', 'timeFrame': '3 years (4 yearly measurement time-points)', 'description': 'heart rate'}, {'measure': 'Cardiovascular changes - blood pressure', 'timeFrame': '3 years (4 yearly measurement time-points)', 'description': 'blood pressure'}, {'measure': 'Microcirculation', 'timeFrame': '3 years (4 yearly measurement time-points)', 'description': 'retinal camera (retinal imaging)'}, {'measure': 'Changes in subcutaneous adipose tissue', 'timeFrame': '3 years (4 yearly measurement time-points)', 'description': 'Assessment via ultrasound'}, {'measure': 'Changes in physical fitness - handgrip', 'timeFrame': '3 years (4 yearly measurement time-points)', 'description': 'Strength via handgrip measurement'}, {'measure': 'Changes in physical fitness - running', 'timeFrame': '3 years (4 yearly measurement time-points)', 'description': 'Endurance via interval running test for 10 minutes'}, {'measure': 'Changes in physical fitness - coordination', 'timeFrame': '3 years (4 yearly measurement time-points)', 'description': 'coordination tested via Dordel-Koch-Test'}, {'measure': 'Changes in cognitive performance parameters - concentration', 'timeFrame': '3 years (4 yearly measurement time-points)', 'description': 'concentration tests'}, {'measure': 'Changes in cognitive performance parameters - reading', 'timeFrame': '3 years (4 yearly measurement time-points)', 'description': 'reading comprehension via regular school tests'}, {'measure': 'Changes in cognitive performance parameters - mathematics', 'timeFrame': '3 years (4 yearly measurement time-points)', 'description': 'mathematics via regular school tests'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Physical Activity', 'Cardiometabolic Health']}, 'referencesModule': {'references': [{'pmid': '28454531', 'type': 'BACKGROUND', 'citation': 'Fredriksen PM, Hjelle OP, Mamen A, Meza TJ, Westerberg AC. The health Oriented pedagogical project (HOPP) - a controlled longitudinal school-based physical activity intervention program. BMC Public Health. 2017 Apr 28;17(1):370. doi: 10.1186/s12889-017-4282-z.'}, {'pmid': '35722126', 'type': 'DERIVED', 'citation': 'Goswami N, Hansen D, Gumze G, Brix B, Schmid-Zalaudek K, Fredriksen PM. Health and Academic Performance With Happy Children: A Controlled Longitudinal Study Based on the HOPP Project. Front Cardiovasc Med. 2022 Jun 3;9:820827. doi: 10.3389/fcvm.2022.820827. eCollection 2022.'}]}, 'descriptionModule': {'briefSummary': "Children and young people are moving less and less. In combination with an unhealthy diet, this has led to a sharp increase in overweight and obesity among children worldwide. Very often, physical illnesses occur in adolescence that can be directly attributed to the overweight and obesity. In order to protect children from these consequences in time, a daily exercise unit of 45 minutes is built into their learning. This exercise will take place in addition to physical education classes as part of your child's school day and will be conducted by a teacher. We will examine the children of the participating schools with regard to health-related characteristics."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '12 Years', 'minimumAge': '6 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* students in participating schools\n\nExclusion Criteria:\n\n* none'}, 'identificationModule': {'nctId': 'NCT04956003', 'briefTitle': 'Optimizing Cardiometabolic Health, Cognition and Academic Performance in Children (HAPHC)', 'organization': {'class': 'OTHER', 'fullName': 'Medical University of Graz'}, 'officialTitle': 'Optimizing Cardiometabolic Health, Cognition and Academic Performance With Happy Children (HAPHC) Using School-based Physical Activity', 'orgStudyIdInfo': {'id': 'HAPPY CHILDREN'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Control Group', 'description': 'No intervention, but assessment of cardiometabolic health and cognition'}, {'type': 'EXPERIMENTAL', 'label': 'Intervention Group', 'description': 'Implementing a daily 45-minute physical activity session as an integral part of learning.', 'interventionNames': ['Behavioral: 45-minute daily physical activity']}], 'interventions': [{'name': '45-minute daily physical activity', 'type': 'BEHAVIORAL', 'description': '45-minute daily physical activity session as an integral part of learning (during regular school sessions)', 'armGroupLabels': ['Intervention Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '8036', 'city': 'Graz', 'state': 'Styria', 'status': 'RECRUITING', 'country': 'Austria', 'contacts': [{'name': 'Goswami Nandu, MD', 'role': 'CONTACT', 'email': 'nandu.goswami@medunigraz.at'}], 'facility': 'Medical University of Graz', 'geoPoint': {'lat': 47.06733, 'lon': 15.44197}}], 'centralContacts': [{'name': 'Nandu Goswami, Dr.', 'role': 'CONTACT', 'email': 'nandu.goswami@medunigraz.at', 'phone': '+43 664 7924948'}, {'name': 'Karin Schmid Zalaudek, Dr.', 'role': 'CONTACT', 'email': 'karin.schmid@medunigraz.at', 'phone': '+43 676 7204142'}], 'overallOfficials': [{'name': 'Nandu Goswami, Dr.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Medical University of Graz'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Medical University of Graz', 'class': 'OTHER'}, 'collaborators': [{'name': 'Kristiania University College', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}