Ignite Creation Date:
2025-12-24 @ 5:18 PM
Ignite Modification Date:
2026-01-10 @ 3:21 PM
Study NCT ID:
NCT05309850
Status:
RECRUITING
Last Update Posted:
2025-07-16
First Post:
2022-03-25
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Primary Prevention With the Lifestyle Tool
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D003924', 'term': 'Diabetes Mellitus, Type 2'}], 'ancestors': [{'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Participants get access to the tool or get assigned to a control group without access'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 90000}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-04-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-07', 'completionDateStruct': {'date': '2026-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-07-13', 'studyFirstSubmitDate': '2022-03-25', 'studyFirstSubmitQcDate': '2022-03-25', 'lastUpdatePostDateStruct': {'date': '2025-07-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-04-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence of major adverse cardiovascular event', 'timeFrame': '3 years', 'description': 'Incidence of major adverse cardiovascular event, defined as cardiovascular death, myocardial infarction, stroke, or hospitalization for heart failure compared between participants regularly using the tool and on usual care.'}, {'measure': 'Incidence of type 2 diabetes', 'timeFrame': '3 yars', 'description': 'Incidence of type 2 diabetes defined as random plasma glucose \\>11.1 mmol/L or fasting glucose \\>7.0 mmol/L or HbA1C ≥6.5% compared between participants regularly using the tool and on usual care.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Cardiovascular Diseases', 'Type 2 Diabetes']}, 'descriptionModule': {'briefSummary': 'In this study participants will be randomized to use a digital lifestyle tool over three years or to a control group without access to the tool. The investigators will prospectively via clinical registries follow the incidence and development of type 2 diabetes and cardiovascular disease in those using the tool regularly and those in the control group.', 'detailedDescription': "Cardiovascular disease (CVD) and type 2 diabetes (T2D) remain leading cause of death in most European countries, and new strategies for prevention are urgently needed.\n\nConsiderable evidence suggest that lifestyle changes can prevent or delay the onset of type 2 diabetes and cardiovascular disease. Modifiable lifestyle factors have been established as key drivers of disease onset and progression.\n\nMany prevention programmes are, however, time-limited and fail to provide continuous support. They also require substantial costs and healthcare resources. Furthermore, accessibility to primary and secondary cardiac prevention programmes is highly variable, as is long-term adherence to lifestyle advice.\n\nIn light of this, international associations have emphasized the need for innovative, scalable and cost-effective lifestyle interventions that could be integrated into pre-existing healthcare structures. Digital tools have large potential for clinical utility, but there are several important knowledge gaps. First, data on long-term efficacy is scarce. Second, most studies to date have included only small number of individuals, and there is a need for large randomized controlled studies. Third, cost-effectiveness remains to be demonstrated.\n\nThe objective or this study is to evaluate a new web-based tool, developed at the University Gothenburg, Sweden, that aims to support patient autonomy and motivation to make sustainable lifestyle changes.\n\nThe investigators will test the hypothesis that individuals who have access to the tool get lower incidence of major cardiovascular events (MACE) and type 2 diabetes or in case they already have diabetes develop improved glucose control compared with control individuals.\n\nThe study is an investigator-initiated single-center study conducted over three years.\n\nThe tool is web-based and used via a computer or mobile phone. It is used at each individual's preferred pace but participants are recommended to login at least every other week. Every round the participants choose a themes (out of appr. 80 possible covering e.g. food, exercise, stress, self-reflection aspects), which takes appr. 15-30 minutes to complete. Participants then reflect on the content and how it could be implemented in daily life. When returning for next round participants are asked to reflect on any changes done since last time. There is no interaction between individual participants."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '35 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* informed consent\n* Age above 35 years\n\nExclusion Criteria:\n\n* type 1 diabetes, MODY or secondary diabetes\n* conditions or treatments that in the judgement of the Investigator could affect the study evaluation\n* connection with the study team, funders, authorities, universities or other public or private bodies in such a way that specific interests in the study outcomes could be suspected.'}, 'identificationModule': {'nctId': 'NCT05309850', 'briefTitle': 'Primary Prevention With the Lifestyle Tool', 'organization': {'class': 'OTHER', 'fullName': 'Region Skane'}, 'officialTitle': 'Primary Disease Prevention With the Lifestyle Tool', 'orgStudyIdInfo': {'id': 'Lifestyle2'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Usage of tool', 'description': 'Participants get access to the tool and use it regularly', 'interventionNames': ['Behavioral: Lifestyle tool']}, {'type': 'NO_INTERVENTION', 'label': 'Controls on usual care', 'description': 'Participants who get randomized to control cannot access the tool. Development of cardiovascular disease or type 2 diabetes is followed via clinical registries.'}], 'interventions': [{'name': 'Lifestyle tool', 'type': 'BEHAVIORAL', 'description': 'Regular use of the digital Lifestyle tool', 'armGroupLabels': ['Usage of tool']}]}, 'contactsLocationsModule': {'locations': [{'zip': '20502', 'city': 'Malmo', 'status': 'RECRUITING', 'country': 'Sweden', 'contacts': [{'name': 'Anders Rosengren', 'role': 'CONTACT', 'email': 'anders.rosengren@gu.se'}], 'facility': 'Skane University Hospital', 'geoPoint': {'lat': 55.60587, 'lon': 13.00073}}], 'centralContacts': [{'name': 'Birgitta Abrahamsson', 'role': 'CONTACT', 'email': 'birgitta.x.abrahamsson@skane.se', 'phone': '0705316704'}], 'overallOfficials': [{'name': 'Anders Rosengren', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Göteborg University'}]}, 'ipdSharingStatementModule': {'timeFrame': 'Data will be available after publication.', 'ipdSharing': 'YES', 'description': 'Individual participant data that underlie the results will be shared after deidentification.', 'accessCriteria': 'To researchers who provide a methodologically sound proposal in order to achieve the aims of that proposal. Proposals should be directed by email to internetverktyg@gu.se'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Region Skane', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}