NCT06847633 A Digital Lifestyle Intervention in Primary Healthcare to Prevent Cardiovascular Disease
| NCT ID | NCT06847633 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Karolinska Institutet |
| Condition | Cardiovascular Diseases |
| Study Type | INTERVENTIONAL |
| Enrollment | 1,000 participants |
| Start Date | 2025-03-03 |
| Primary Completion | 2027-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 1,000 participants in total. It began in 2025-03-03 with a primary completion date of 2027-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
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
Contact & Investigator
Marie Löf, PhD
PRINCIPAL INVESTIGATOR
Karolinska Institutet
Frequently Asked Questions
Who can join the NCT06847633 clinical trial?
This trial is open to participants of all sexes, aged 39 Years or older, up to 61 Years, studying Cardiovascular Diseases. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06847633 currently recruiting?
Yes, NCT06847633 is actively recruiting participants. Contact the research team at linnea.hedin@ki.se for enrollment information.
Where is the NCT06847633 trial being conducted?
This trial is being conducted at Gävle, Sweden, Halmstad, Sweden, Linköping, Sweden, Malmö, Sweden and 2 additional locations.
Who is sponsoring the NCT06847633 clinical trial?
NCT06847633 is sponsored by Karolinska Institutet. The principal investigator is Marie Löf, PhD at Karolinska Institutet. The trial plans to enroll 1,000 participants.