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
13 weeks
Total Duration
On this page
Sponsors
K
Karolinska Institutet
Lead Sponsor
C
Capio Narsjukvard
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating whether a digital lifestyle intervention developed within Swedish primary healthcare can improve important heart health outcomes and lifestyle habits. This study focuses on adults aged 40 to 60 years with cardiovascular risk factors and aims to prevent cardiovascular diseases by supporting healthier behaviors such as diet, physical activity, alcohol use, and tobacco use. Participants are randomly assigned to either receive the digital lifestyle intervention or continue with standard care. All participants have a structured health dialogue focused on lifestyle habits. Those in the intervention group also get access to digital lectures, home assignments, group meetings, and personalized support from healthcare providers. The study measures outcomes primarily at 6 months after randomization. During the study, participants will be monitored for changes in LDL-cholesterol, blood lipids, blood sugar, blood pressure, weight, body measurements, cardiovascular risk, and lifestyle behaviors including diet, physical activity, sleep, stress, alcohol, and tobacco use. Quality of life and participant experiences with the digital intervention will also be assessed. The total participation includes follow-up assessments at 6 months to evaluate the intervention's impact on heart health and lifestyle.
CONDITIONS
Brief 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 at primary healthcare for patients aged 40 to 60 years
- Willing to change at least one lifestyle behavior related to physical activity, diet, smoking or snus, alcohol, sleep, or stress
You will not qualify if you...
- Diagnosis of diabetes
- Heart failure
- History of myocardial infarction (heart attack)
- History of stroke
- Pregnancy
AI-Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 6 months
Participants receive a digital lifestyle intervention providing support through digital lectures, home assignments, group meetings, and personalized digital feedback to promote healthier lifestyle behaviors.
Regular digital interactions and support; 1 baseline visit and 1 follow-up visit
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
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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