Ireland
--:--IST
Recruiting Not applicable

A Digital Lifestyle Intervention in Primary Healthcare to Prevent Cardiovascular Disease

NCT06847633 · tracked via the Priya Life Science Sweden tracker
Phase
Not applicable
Started
2025-03-03
Last updated
2026-06-09

Condition(s) studied

Cardiovascular DiseasesLifestyle Factors

Investigational drug(s) / intervention(s)

Digital lifestyle intervention

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

Sex
ALL
Min age
39 Years
Max age
61 Years
Healthy volunteers
No
Inclusion Criteria: * 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 Exclusion Criteria: * diabetes * heart failure * history of myocardial infarction * history of stroke * pregnancy

Primary outcome measure(s)

  • LDL-cholesterol — 6 months post-randomization
    Low density lipoprotein cholesterol

Trial sites (6)

FacilityCityRegionStatus
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
Official registry record

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