RecruitingNot ApplicableNCT06847633

A Digital Lifestyle Intervention in Primary Healthcare to Prevent Cardiovascular Disease


Sponsor

Karolinska Institutet

Enrollment

1,000 participants

Start Date

Mar 3, 2025

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 39 YearsMax Age: 61 Years

Inclusion Criteria2

  • 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 Criteria5

  • diabetes
  • heart failure
  • history of myocardial infarction
  • history of stroke
  • pregnancy

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Interventions

BEHAVIORALDigital 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


Locations(6)

Primary helathcare centers in Region Gävleborg

Gävle, Sweden

Primary healthcare centers in Region Halland

Halmstad, Sweden

Primay healthcare centers in Region Östergötland

Linköping, Sweden

Primary healthcare centers in region Skåne

Malmö, Sweden

Primary healthcare centers in Region Västerbotten

Umeå, Sweden

Primary healthcare centers in Region Västmanland

Västerås, Sweden

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NCT06847633


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