Clinical trial NCT05309850: Primary Prevention With the Lifestyle Tool
Official title: Primary Disease Prevention With the Lifestyle Tool
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Cardiovascular Diseases
Type 2 Diabetes
Lead sponsor: Region Skane
Sponsor class: OTHER
First posted: 2022-04-04
Enrollment: 90000
Sex: ALL
Minimum age (years): 35
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants get access to the tool or get assigned to a control group without access
Primary purpose: PREVENTION

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* informed consent
* Age above 35 years

Exclusion Criteria:

* type 1 diabetes, MODY or secondary diabetes
* 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.

Primary outcomes:
measure: Incidence of major adverse cardiovascular event
timeFrame: 3 years
measure: Incidence of type 2 diabetes
timeFrame: 3 yars
Secondary outcomes:
Other outcomes:
Locations:
city: Malmo
country: Sweden
facility: Skane University Hospital
Study officials:
affiliation: Göteborg University
name: Anders Rosengren
role: PRINCIPAL_INVESTIGATOR
References: