Actively Recruiting

Phase Not Applicable
Age: 39Years - 61Years
All Genders
NCT06847633

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

Age: 39Years - 61Years
All Genders

Eligibility Criteria

Eligible

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
Not Eligible

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

1
2
3
+1

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

Loading map...

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

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here

A Digital Lifestyle Intervention in Primary Healthcare to Prevent Cardiovascular Disease | DecenTrialz