A Digital Lifestyle Intervention in Primary Healthcare to Prevent Cardiovascular Disease

Karolinska Institute

Status: Enrolling

Conditions: Lifestyle Factors; Cardiovascular Diseases

Treatments: Behavioral: Digital lifestyle intervention

Study type: Interventional

Funder types: Other

Identifiers

NCT06847633

2024-07911-01

Details and patient eligibility

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.

Enrollment: 1,000 estimated patients

Sex: All

Ages: 39 to 61 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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1,000 participants in 2 patient groups

Digital lifestyle intervention

Experimental group

Description:

Access to the digital intervention which will provide support for healthier lifestyle behaviors regarding diet, physical activity, sleep, stress, alcohol consumption, and use of tobacco.

Treatment:

Behavioral: Digital lifestyle intervention

Control arm

No Intervention group

Description:

Standard care i.e., a routine appointment to the primary healthcare center for discussing lifestyle habits