Ignite Creation Date:
2025-12-24 @ 7:14 PM
Ignite Modification Date:
2025-12-28 @ 8:56 AM
Study NCT ID:
NCT04727203
Status:
UNKNOWN
Last Update Posted:
2022-07-21
First Post:
2021-01-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Active and Healthy Ageing for All: a Multi-component Healthy Lifestyle Program
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D015444', 'term': 'Exercise'}, {'id': 'D019908', 'term': 'Proto-Oncogene Proteins c-raf'}], 'ancestors': [{'id': 'D009043', 'term': 'Motor Activity'}, {'id': 'D009068', 'term': 'Movement'}, {'id': 'D009142', 'term': 'Musculoskeletal Physiological Phenomena'}, {'id': 'D055687', 'term': 'Musculoskeletal and Neural Physiological Phenomena'}, {'id': 'D048490', 'term': 'raf Kinases'}, {'id': 'D020930', 'term': 'MAP Kinase Kinase Kinases'}, {'id': 'D017346', 'term': 'Protein Serine-Threonine Kinases'}, {'id': 'D011494', 'term': 'Protein Kinases'}, {'id': 'D017853', 'term': 'Phosphotransferases (Alcohol Group Acceptor)'}, {'id': 'D010770', 'term': 'Phosphotransferases'}, {'id': 'D014166', 'term': 'Transferases'}, {'id': 'D004798', 'term': 'Enzymes'}, {'id': 'D045762', 'term': 'Enzymes and Coenzymes'}, {'id': 'D047908', 'term': 'Intracellular Signaling Peptides and Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D011518', 'term': 'Proto-Oncogene Proteins'}, {'id': 'D015513', 'term': 'Oncogene Proteins'}, {'id': 'D009363', 'term': 'Neoplasm Proteins'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'There are 6 groups in this intervention'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 400}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2019-09-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-07', 'completionDateStruct': {'date': '2024-09-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-07-18', 'studyFirstSubmitDate': '2021-01-15', 'studyFirstSubmitQcDate': '2021-01-22', 'lastUpdatePostDateStruct': {'date': '2022-07-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-01-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Physical activity measured by IPAQ', 'timeFrame': 'up to twelve weeks', 'description': 'Subjective physical activity'}, {'measure': 'Physical activity measured by accelerometry', 'timeFrame': 'up to twelve weeks', 'description': 'Objective physical activity'}, {'measure': 'Sedentary behaviour measured by accelerometry', 'timeFrame': 'up to twelve weeks', 'description': 'Objective sedentary behaviour'}, {'measure': 'Sedentary behaviour measured by IPAQ', 'timeFrame': 'up to twelve weeks', 'description': 'Subjective sedentary behaviour'}, {'measure': 'Nutrition questionnaire (self-reported)', 'timeFrame': 'up to twelve weeks', 'description': 'Nutrition'}, {'measure': 'Sleep measured by accelerometry', 'timeFrame': 'up to twelve weeks', 'description': 'Objective sleep'}, {'measure': 'Sleep measured by PSQI', 'timeFrame': 'up to twelve weeks', 'description': 'Subjective sleep'}], 'secondaryOutcomes': [{'measure': 'well-being measured by WEMWBS', 'timeFrame': 'up to twelve weeks', 'description': 'well-being'}, {'measure': 'Perceived stress measured by the perceived stress scale', 'timeFrame': 'up to twelve weeks', 'description': 'Perceived stress of participants'}, {'measure': 'Perceived positive health status measured by a self-reported questionnaire', 'timeFrame': 'up to twelve weeks', 'description': 'Perceived positive health status'}, {'measure': 'Health literacy measured by HLSQ self-reported questionnaire', 'timeFrame': 'up to twelve weeks', 'description': 'Health literacy'}, {'measure': 'Social support measured by a self-reported questionnaire', 'timeFrame': 'up to twelve weeks', 'description': 'Social Support'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['ageing', 'healthy lifestyle', 'intervention'], 'conditions': ['Health Promotion']}, 'descriptionModule': {'briefSummary': 'AHAA is a healthy lifestyle program offered to older adults aged 60+ years. The program is developed based upon co-creation with the target group and implemented and evaluated in several locations.', 'detailedDescription': '1. co-creation : all participants will be questioned and included in the co-creation session\n2. implementation : the developed multicomponent healthy lifestyle program will be enrolled and implemented in 6 locations (community services for older adults in Flanders and Brussels)\n3. evaluation : the program will be evaluated (effects and process)'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '60 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* age 60+ years\n\nExclusion Criteria:\n\n* not being able to attend the weekly meetings'}, 'identificationModule': {'nctId': 'NCT04727203', 'acronym': 'AHAA', 'briefTitle': 'Active and Healthy Ageing for All: a Multi-component Healthy Lifestyle Program', 'organization': {'class': 'OTHER', 'fullName': 'KU Leuven'}, 'officialTitle': 'Active and Healthy Ageing for All: a Multi-component Healthy Lifestyle Program (AHAA)', 'orgStudyIdInfo': {'id': 'AHAA'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intervention', 'description': 'Partcipants in this group will receive the 8 week healthy lifestyle program', 'interventionNames': ['Behavioral: AHAA']}, {'type': 'NO_INTERVENTION', 'label': 'Control', 'description': 'Participants in this group will not receive any intervention'}], 'interventions': [{'name': 'AHAA', 'type': 'BEHAVIORAL', 'otherNames': ['Active and healthy ageing for all'], 'description': 'Multi-component healthy lifestyle program', 'armGroupLabels': ['Intervention']}]}, 'contactsLocationsModule': {'locations': [{'zip': '9300', 'city': 'Aalst', 'status': 'RECRUITING', 'country': 'Belgium', 'contacts': [{'name': 'Julie Vanderlinden', 'role': 'CONTACT', 'email': 'julie.vanderlinden@odisee.be', 'phone': '003216321861'}], 'facility': 'LDC', 'geoPoint': {'lat': 50.93604, 'lon': 4.0355}}, {'zip': '1000', 'city': 'Brussels', 'status': 'RECRUITING', 'country': 'Belgium', 'contacts': [{'name': 'Julie Vanderlinden', 'role': 'CONTACT', 'email': 'julie.vanderlinden@odisee.be', 'phone': '003216321861'}], 'facility': 'LDC', 'geoPoint': {'lat': 50.85045, 'lon': 4.34878}}, {'zip': '9000', 'city': 'Ghent', 'status': 'RECRUITING', 'country': 'Belgium', 'contacts': [{'name': 'Julie Vanderlinden', 'role': 'CONTACT', 'email': 'julie.vanderlinden@odisee.be', 'phone': '003216321861'}], 'facility': 'Regie Ouderenzorg', 'geoPoint': {'lat': 51.05, 'lon': 3.71667}}, {'zip': '2800', 'city': 'Mechelen', 'status': 'RECRUITING', 'country': 'Belgium', 'contacts': [{'name': 'Julie Vanderlinden', 'role': 'CONTACT', 'email': 'julie.vanderlinden@odisee.be', 'phone': '003216321861'}], 'facility': 'LDC', 'geoPoint': {'lat': 51.02574, 'lon': 4.47762}}, {'zip': '2800', 'city': 'Sint-Truiden', 'status': 'RECRUITING', 'country': 'Belgium', 'contacts': [{'name': 'Julie Vanderlinden', 'role': 'CONTACT', 'email': 'julie.vanderlinden@odisee.be', 'phone': '003216321861'}], 'facility': 'Triamant', 'geoPoint': {'lat': 50.81679, 'lon': 5.18647}}], 'centralContacts': [{'name': 'Julie Vanderlinden, PHDc', 'role': 'CONTACT', 'email': 'julie.vanderlinden@odisee.be', 'phone': '003216321861'}], 'overallOfficials': [{'name': 'Julie Vanderlinden, PHDc', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'KU Leuven'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'KU Leuven', 'class': 'OTHER'}, 'collaborators': [{'name': 'Odisee University college for applied sciences', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Phdc', 'investigatorFullName': 'Julie Vanderlinden', 'investigatorAffiliation': 'KU Leuven'}}}}