An interventional study of Lifestyle tool in Cardiovascular Diseases and Type 2 Diabetes, sponsored by Region Skane. Recruiting at 1 site in Sweden. Open to participants aged 35 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-07-16.
Sponsored by Region Skane · Not applicable, Interventional, and Prevention
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.
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.
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.
4,905 studies on the registry are indexed under Cardiovascular Diseases; 919 are open to participants now.
This study's planned enrollment of 90,000 is above the median of 100 across 2,738 interventional studies indexed under Cardiovascular Diseases.
Browse Cardiovascular Diseases studies →Region Skane is the lead sponsor of 372 studies on the registry; 113 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Participants get access to the tool and use it regularly
Behavioral: Lifestyle tool
Participants who get randomized to control cannot access the tool. Development of cardiovascular disease or type 2 diabetes is followed via clinical registries.
Regular use of the digital Lifestyle tool
Incidence of major adverse cardiovascular event
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.
Time frame: 3 years
Incidence of type 2 diabetes
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.
Time frame: 3 yars
Plan to share: Yes — Individual participant data that underlie the results will be shared after deidentification.
No publications or documents are linked to this record.
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Region Skane