A Digital Lifestyle Intervention in Primary Healthcare to Prevent Cardiovascular Disease

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age39-61
SponsorKarolinska Institutet

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

diabetes

heart failure

history of myocardial infarction

history of stroke

Trial design

Design model

Parallel

Treatments tested in this trial

  • Digital lifestyle intervention

    Behavioral

    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

Treatment groups

1,000 Participants
are divided into 2 treatment groups
Group A: Digital lifestyle interventionExperimental treatment 1 intervention
Group B: Control armNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

LDL-cholesterol

Low density lipoprotein cholesterol

Time frame
6 months post-randomization

Secondary outcomes

1

HDL-cholesterol

High density lipoprotein cholesterol

Time frame
6 months post-randomization
2

Total cholesterol

Time frame
6 months post-randomization
3

Fasting blood glucose

Time frame
6 months post-randomization
4

Triglycerides

Time frame
6 months post-randomization

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Karolinska Institutet

Lead sponsor

Capio Narsjukvard

Collaborator