Actively Recruiting
A Digital Lifestyle Intervention in Primary Healthcare to Prevent Cardiovascular Disease
Led by Karolinska Institutet · Updated on 2025-05-21
1000
Participants Needed
6
Research Sites
117 weeks
Total Duration
On this page
Sponsors
K
Karolinska Institutet
Lead Sponsor
C
Capio Narsjukvard
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
A Digital Lifestyle Intervention in Primary Healthcare to Prevent Cardiovascular Disease
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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
You will not qualify if you...
- Diabetes
- Heart failure
- History of myocardial infarction
- History of stroke
- Pregnancy
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 6 locations
1
Primary helathcare centers in Region Gävleborg
Gävle, Sweden
Not Yet Recruiting
2
Primary healthcare centers in Region Halland
Halmstad, Sweden
Actively Recruiting
3
Primay healthcare centers in Region Östergötland
Linköping, Sweden
Not Yet Recruiting
4
Primary healthcare centers in region Skåne
Malmö, Sweden
Actively Recruiting
5
Primary healthcare centers in Region Västerbotten
Umeå, Sweden
Not Yet Recruiting
6
Primary healthcare centers in Region Västmanland
Västerås, Sweden
Actively Recruiting
Research Team
L
Linnea Hedin, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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