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Cardiovascular DiseasesNCT06847633

A Digital Lifestyle Intervention in Primary Healthcare to Prevent Cardiovascular Disease

A study testing Digital lifestyle intervention in people with Cardiovascular Diseases and Lifestyle Factors, run by Karolinska Institutet at 6 sites in Sweden.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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… Read more about this study

Who is it for?
Ages 39 to 61 years
Conditions the study is for
Cardiovascular Diseases, Lifestyle Factors
What is being tested?
Digital lifestyle intervention
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,000 participants
Where
6 sitesSweden
Study dates
3 Mar 2025to Dec 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 39 to 61 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • 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

Who cannot join

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

Trial locations and contacts

6 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Linnea Hedin, PhD contact

+4670-2473149

linnea.hedin@ki.se

6 sites in 1 country

Sweden6 sites, 6 recruiting

  • Primary helathcare centers in Region Gävleborg

    Gävle

    Not yet recruiting

  • Primary healthcare centers in Region Halland

    Halmstad

    +46702473149

    Recruiting

  • Primay healthcare centers in Region Östergötland

    Linköping

    Recruiting

  • Primary healthcare centers in region Skåne

    Malmö

    +46702473149

    Recruiting

  • Primary healthcare centers in Region Västerbotten

    Umeå

    +46702473149

    Recruiting

  • Primary healthcare centers in Region Västmanland

    Västerås

    Recruiting

Other trials in Sweden

About this study

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.

Being tested
Digital lifestyle intervention
Medical subject headings
Cardiovascular Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Digital lifestyle interventionBehavioural

    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

Study groups in NCT06847633
Study groupRoleWhat they receive
Digital lifestyle interventionExperimentalAccess to the digital intervention which will provide support for healthier lifestyle behaviors regarding diet, physical activity, sleep, stress, alcohol consumption, and use of tobacco.
Receives: Behavioral: Digital lifestyle intervention
Control armNo interventionStandard care i.e., a routine appointment to the primary healthcare center for discussing lifestyle habits

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. LDL-cholesterol

    Low density lipoprotein cholesterol

    Measured: 6 months post-randomization

Secondary outcomes (23)

  1. HDL-cholesterol

    High density lipoprotein cholesterol

    Measured: 6 months post-randomization

  2. Total cholesterol

    Measured: 6 months post-randomization

  3. Fasting blood glucose

    Measured: 6 months post-randomization

  4. Triglycerides

    Measured: 6 months post-randomization

  5. Non-HDL cholesterol

    Calculated by subtracting HDL cholesterol from total cholesterol

    Measured: 6 months post-randomization

  6. Systolic blood pressure

    Measured: 6 months post-randomization

  7. Diastolic blood pressure

    Measured: 6 months post-randomization

  8. Weight

    Measured: 6 months post-randomization

  9. Height

    Measured: 6 months post-randomization

  10. Body mass index

    Measured: 6 months post-randomization

  11. Waist circumference

    Measured: 6 months post-randomization

  12. Systematic COronary Risk Evaluation model, second version (SCORE2)

    Estimated percentage risk of fatal and non-fatal cardiovascular disease within the next 10 years. The estimation is based on data on sex, age, smoking, systolic blood pressure (SBP), total cholesterol, and HDL cholesterol

    Measured: 6 months post-randomization

  13. Health-related quality of life

    Measured by the questionnaire EuroQol-5 Dimensions-5 Levels (EQ-5D-5L). Five dimensions including mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has five response options, scored 1-5, ranging from 'no problems' to 'extreme problems'

    Measured: 6 months post-randomization

  14. Health-related quality of life

    Measured by the questionnaire EuroQol-5 Dimensions-5 Levels (EQ-5D-5L) visual analogue scale (VAS) ranging from 0 to 100 where higher values represents better self-assessed health.

    Measured: 6 months post-randomization

  15. Diet intake

    Assessed by questions on intake quantity of vegetables, fruit, sweet beverages, and snacks the past week

    Measured: 6 months post-randomization

  16. Physical activity

    Assessed by questions on time (minutes and hours) spent in moderate and vigorous physical activity the past week

    Measured: 6 months post-randomization

  17. Sedentary time

    One question about time in sitting position

    Measured: 6 months post-randomization

  18. Stress

    Assessed by the Perceived Stress Scale. Minimum value 0. Maximum value 56. Higher scores indicating greater perceived stress.

    Measured: 6 months post-randomization

  19. Sleep

    Assessed by the Karolinska Sleep Questionnaire. No single set of minimum and maximum values. Each item is scored from 0-5, where higher values indicate greater sleep issues

    Measured: 6 months post-randomization

  20. Alcohol consumption

    Questions on monthly frequency of heavy episodic drinking, weekly alcohol consumption

    Measured: 6 months post-randomization

  21. Tobacco use

    Questions on frequency of smoking and using snus the past week and the past 4 weeks

    Measured: 6 months post-randomization

  22. Mediated effects on behavior change

    Potential mediators to be assessed are confidence, importance, and know-how (i.e., knowing how to change a behavior).

    Measured: 6 months post-randomization

  23. Participant experience from using the digital intervention

    Questions on experience from using the intervention (intervention group only). The questions are framed as statements with five response options ranging from 'Not agreeing at all' to 'Fully agreeing'

    Measured: 6 months post-randomization

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Feb 2025
  2. Study start3 Mar 2025
  3. Primary completionDec 2027 (estimated)
  4. Study completionDec 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
1,000 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06847633
Sponsor's protocol ID
2024-07911-01
Other IDs
2025-07793, 2025
Status last verified
Jun 2026
First submitted
21 Feb 2025
Last updated
9 Jun 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Digital lifestyle intervention in people with Cardiovascular Diseases and Lifestyle Factors, run by Karolinska Institutet at 6 sites in Sweden.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 9 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 sites in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Linnea Hedin, PhD (+4670-2473149, linnea.hedin@ki.se), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

LDL-cholesterol (time frame: 6 months post-randomization). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06847633.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jun 2026.

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