About this trial
Unhealthy lifestyle behaviors are well-established risk factors for cardiovascular disease (CVD) which is the leading cause of death globally and in Sweden. Digitalization offers new and better possibilities for healthcare to fulfil their responsibility to support healthier lifestyles, however, to ensure scalability and sustained implementation of digital tools within healthcare, digital interventions need to be systematically maintained and delivered by the primary healthcare. The aim of this project is to evaluate whether a digital lifestyle intervention, developed within Swedish primary healthcare, can improve clinically important cardiovascular health outcomes and lifestyle behaviors. In this multi-center randomized controlled trial patients, 40-60 years, in Swedish primary healthcare will be recruited and randomized to the control or intervention group. All participants will receive standard care consisting of one structured health dialogue focused on lifestyle habits. The intervention group will also receive support through the digital lifestyle intervention for creating healthy habits regarding diet, physical activity, alcohol consumption, and tobacco usage. The primary outcome is LDL-cholesterol at 6 months post-randomization. Secondary outcomes 6 months post-randomization are HDL-, total cholesterol, fasting blood glucose, triglycerides, non-HDL, blood pressure, weight, height, BMI, waist circumference, cardiovascular risk evaluation (SCORE2), dietary intake, physical activity, sleep, stress, alcohol consumption, tobacco use, and health-related quality of life.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Attended a Health dialogue visit to primary healthcare for patients 40-60 years old
Willing to change at least one lifestyle behavior regarding physical activity, diet, smoking/snus, alcohol, sleep, or stress
Disqualifiers
diabetes
heart failure
history of myocardial infarction
history of stroke
Trial design
Parallel
Treatments tested in this trial
Digital lifestyle intervention
BehavioralThe digital lifestyle intervention provides support to the patient through digital lectures, home assignments and digital group meetings as well as provides the possibility for the healthcare provider to provide personalized digital support and feedback to the patient
Treatment groups
Trial outcomes
Primary outcomes
LDL-cholesterol
Low density lipoprotein cholesterol
Secondary outcomes
HDL-cholesterol
High density lipoprotein cholesterol
Total cholesterol
Fasting blood glucose
Triglycerides
Sponsors and contacts
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Karolinska Institutet
Lead sponsor
Capio Narsjukvard
Collaborator