Ignite Creation Date:
2025-12-24 @ 6:51 PM
Ignite Modification Date:
2025-12-30 @ 5:53 AM
Study NCT ID:
NCT02744157
Status:
COMPLETED
Last Update Posted:
2016-04-20
First Post:
2016-03-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Long Term Effects of a Structured Lifestyle Program
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 102}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-04', 'completionDateStruct': {'date': '2014-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-04-19', 'studyFirstSubmitDate': '2016-03-03', 'studyFirstSubmitQcDate': '2016-04-19', 'lastUpdatePostDateStruct': {'date': '2016-04-20', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-04-20', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Cardiovascular risk', 'timeFrame': 'change from baseline in waist circumference after one year', 'description': 'change from baseline in waist circumference after one year'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Lifestyle', 'Quality of Life']}, 'referencesModule': {'references': [{'pmid': '29609555', 'type': 'DERIVED', 'citation': 'Lidin M, Hellenius ML, Rydell-Karlsson M, Ekblom-Bak E. Long-term effects on cardiovascular risk of a structured multidisciplinary lifestyle program in clinical practice. BMC Cardiovasc Disord. 2018 Apr 2;18(1):59. doi: 10.1186/s12872-018-0792-6.'}]}, 'descriptionModule': {'briefSummary': 'The aim of the present study was to describe a structured intervention to reduce cardiovascular risk in a clinical setting and to study the effects of the program on lifestyle habits and quality of life in individuals at risk after six months and one year.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion criteria:\n\n(three risk factors )\n\n* cardiovascular disease\n* physical inactivity\n* smoking\n* risk consumption of alcohol\n* unhealthy food habits\n* stress\n* overweight or abdominal obesity\n* high lipids (cholesterol, LDL)\n* high blood pressure\n* diabetes/insulin resistance.\n\nExclusion criteria:\n\n* Not understand Swedish language'}, 'identificationModule': {'nctId': 'NCT02744157', 'briefTitle': 'Long Term Effects of a Structured Lifestyle Program', 'organization': {'class': 'OTHER', 'fullName': 'Karolinska University Hospital'}, 'officialTitle': 'Long Term Effects on Lifestyle Habits and Quality of Life in Individuals With Increased Cardiometabolic Risk Participating in a Structured Lifestyle Intervention Program', 'orgStudyIdInfo': {'id': '2015/494-31/2'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'structured lifestyle program', 'description': 'The program consisted of an individual visit to a nurse for a health check-up and lifestyle counseling at baseline, six month and one year. The program also consisted of five group educations which included lectures on nicotine, alcohol, physical inactivity, eating habits, stress, sleeping habits and behavior changes', 'interventionNames': ['Behavioral: Longterm effects after a structured lifestyle program']}], 'interventions': [{'name': 'Longterm effects after a structured lifestyle program', 'type': 'BEHAVIORAL', 'description': 'present study was to describe a structured intervention to reduce cardiovascular risk in a clinical setting and to study the effects of the program on lifestyle habits and quality of life in individuals at risk after six months and one year.', 'armGroupLabels': ['structured lifestyle program']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Mai-Lis Hellenius, Professor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Karolinska Institutet, Department of medicine and Karolinska University Hospital,Department of Cardiology'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Karolinska University Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'Region Stockholm', 'class': 'OTHER_GOV'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Mai-Lis Hellenius', 'investigatorAffiliation': 'Karolinska University Hospital'}}}}