A Digital Lifestyle Intervention in Primary Healthcare to Prevent Cardiovascular Disease
Condition(s) studied
Investigational drug(s) / intervention(s)
Digital lifestyle intervention: The 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
Study summary
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
Primary outcome measure(s)
- LDL-cholesterol — 6 months post-randomization
Low density lipoprotein cholesterol
Trial sites (6)
| Facility | City | Region | Status |
|---|---|---|---|
| Primary helathcare centers in Region Gävleborg | Gävle | Sweden | Not Yet Recruiting |
| Primary healthcare centers in Region Halland | Halmstad | Sweden | Recruiting |
| Primay healthcare centers in Region Östergötland | Linköping | Sweden | Recruiting |
| Primary healthcare centers in region Skåne | Malmö | Sweden | Recruiting |
| Primary healthcare centers in Region Västerbotten | Umeå | Sweden | Recruiting |
| Primary healthcare centers in Region Västmanland | Västerås | Sweden | Recruiting |
More Karolinska Institutet trials in Sweden
Other trials for the same condition
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT06847633 on ClinicalTrials.gov ↗ ← All trials in Sweden