Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
90000 participants
INTERVENTIONAL
2022-04-05
2026-12-31
Brief Summary
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Detailed Description
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Considerable 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.
Many 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.
In 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.
The 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.
The 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.
The study is an investigator-initiated single-center study conducted over three years.
The 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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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Usage of tool
Participants get access to the tool and use it regularly
Lifestyle tool
Regular use of the digital Lifestyle tool
Controls on usual care
Participants who get randomized to control cannot access the tool. Development of cardiovascular disease or type 2 diabetes is followed via clinical registries.
No interventions assigned to this group
Interventions
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Lifestyle tool
Regular use of the digital Lifestyle tool
Eligibility Criteria
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Inclusion Criteria
* Age above 35 years
Exclusion Criteria
* conditions or treatments that in the judgement of the Investigator could affect the study evaluation
* 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.
35 Years
ALL
Yes
Sponsors
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Region Skane
OTHER
Responsible Party
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Principal Investigators
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Anders Rosengren
Role: PRINCIPAL_INVESTIGATOR
Göteborg University
Locations
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Skane University Hospital
Malmo, , Sweden
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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Lifestyle2
Identifier Type: -
Identifier Source: org_study_id
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