Ignite Creation Date:
2025-12-24 @ 11:51 PM
Ignite Modification Date:
2025-12-25 @ 9:46 PM
Study NCT ID:
NCT05412251
Status:
UNKNOWN
Last Update Posted:
2023-05-17
First Post:
2022-06-06
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Smart Integrated Health Promotion Program
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT'], 'maskingDescription': 'control group and experimental group'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'control group and experimental group'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 160}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-02-18', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-02', 'completionDateStruct': {'date': '2024-02-17', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-05-15', 'studyFirstSubmitDate': '2022-06-06', 'studyFirstSubmitQcDate': '2022-06-06', 'lastUpdatePostDateStruct': {'date': '2023-05-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-06-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-02-17', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Changes from baseline one touch blood sugar in mg/dl at 3, 6, 9 month', 'timeFrame': 'baseline, 3, 6, 9 month', 'description': 'Changes from baseline one touch blood sugar in mg/dl at 3, 6, 9 month'}, {'measure': 'Changes from baseline one touch urine acid in mg/dl at 3, 6, 9 month', 'timeFrame': 'baseline, 3, 6, 9 month', 'description': 'Changes from baseline one touch urine acid in mg/dl at 3, 6, 9 month'}, {'measure': 'Changes from baseline one touch total cholesterol in mg/dl at 3, 6, 9 month', 'timeFrame': 'baseline, 3, 6, 9 month', 'description': 'Changes from baseline one touch total cholesterol in mg/dl at 3, 6, 9 month'}], 'primaryOutcomes': [{'measure': 'Changes from baseline life quality at 3, 6, 9 month', 'timeFrame': 'baseline, 3, 6, 9 month', 'description': 'measured by the EuroQol- 5 Dimension (EQ-5D), score range 0-1,The higher the score, the better the quality of life'}, {'measure': 'Changes from baseline life quality at 3, 6, 9 month', 'timeFrame': 'baseline, 3, 6, 9 month', 'description': 'measured by the subjective well-being scale, score range 10-50, The higher the score, the better the quality of life'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['leisure activity', 'nutrition status', 'quality of life', 'subjective well-being', 'older adults'], 'conditions': ['Quality of Life']}, 'referencesModule': {'references': [{'pmid': '40310677', 'type': 'DERIVED', 'citation': 'Lee LY, Tung HH, Liao G, Liu SJ, Chen ZY, Yang YR. Multihealth Promotion Programs on Physical Health and Quality of Life in Older Adults: Quasi-Experimental Study. Interact J Med Res. 2025 May 1;14:e65213. doi: 10.2196/65213.'}]}, 'descriptionModule': {'briefSummary': 'health promotion behavior is important in older adults.The purpose of this study is to examine the efficacy of smart integrated health promotion intervention among middle age adults and older adults in community.', 'detailedDescription': 'There very limited research focused on leisure activity, nutrition status, quality of life and subjective well-being. In addition, there is lack of research develop smart integrated health promotion intervention to enhance well-being for middle age adults older adults in community and examine the efficacy of the intervention. The purpose of this study is to examine the efficacy of smart integrated health promotion intervention among middle age adults and older adults in community .'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '50 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n(1) age over 50 years\n\nExclusion Criteria:\n\n1. those who could not understanding protocol or communication with search nurses;\n2. or with cognitive impairment or mental disorders;\n3. or advance cancer;\n4. or have been myocardial infarction;\n5. or congestive heart failure was excluded.'}, 'identificationModule': {'nctId': 'NCT05412251', 'briefTitle': 'Smart Integrated Health Promotion Program', 'organization': {'class': 'OTHER', 'fullName': 'National Yang Ming Chiao Tung University'}, 'officialTitle': 'Smart Integrated Health Promotion Program and Health Behavior for Older Adult', 'orgStudyIdInfo': {'id': 'YM110168-EF'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'contrl', 'description': 'provide an irregular nutrition counselling to case by nutritionist'}, {'type': 'EXPERIMENTAL', 'label': 'intervention', 'description': 'Multi-domain intervention included exercise,cognitive training and diet education was conducted for five hours per week in the first month, second month and third month.', 'interventionNames': ['Radiation: health promotion program']}], 'interventions': [{'name': 'health promotion program', 'type': 'RADIATION', 'description': 'Multi-domain intervention 120 minutes cognitive training, 120 \\~180 minutes physical exercise per weeks, and 60 minutes diet nutrition education per month', 'armGroupLabels': ['intervention']}]}, 'contactsLocationsModule': {'locations': [{'zip': '632', 'city': 'Taichung', 'status': 'RECRUITING', 'country': 'Taiwan', 'contacts': [{'name': 'George Liao', 'role': 'CONTACT', 'phone': '886-987-817-823'}], 'facility': 'WISON Pharmacy', 'geoPoint': {'lat': 24.1469, 'lon': 120.6839}}], 'centralContacts': [{'name': 'Heng-Hsin Tung, PhD', 'role': 'CONTACT', 'email': 'henghsin@nycu.edu.tw', 'phone': '886-953005831'}, {'name': 'Li-Yun Lee, PhD', 'role': 'CONTACT', 'email': 'leeliyun@mail.dyu.edu.tw', 'phone': '886-929008111'}], 'overallOfficials': [{'name': 'Heng-Hsin Tung, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'National Yang Ming Chiao Tung University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National Yang Ming Chiao Tung University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}