Clinical trial NCT06847633: A Digital Lifestyle Intervention in Primary Healthcare to Prevent Cardiovascular Disease
Official title: A Digital Lifestyle Intervention in Primary Healthcare to Prevent Cardiovascular Disease
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Cardiovascular Diseases
Lifestyle Factors
Lead sponsor: Karolinska Institutet
Sponsor class: OTHER
Collaborators: name: Capio Narsjukvard
First posted: 2025-02-26
Enrollment: 1000
Sex: ALL
Minimum age (years): 39
Maximum age (years): 61
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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 criteria: 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

Primary outcomes:
measure: LDL-cholesterol
timeFrame: 6 months post-randomization
Secondary outcomes:
measure: HDL-cholesterol
timeFrame: 6 months post-randomization
measure: Total cholesterol
timeFrame: 6 months post-randomization
measure: Fasting blood glucose
timeFrame: 6 months post-randomization
measure: Triglycerides
timeFrame: 6 months post-randomization
measure: Non-HDL cholesterol
timeFrame: 6 months post-randomization
measure: Systolic blood pressure
timeFrame: 6 months post-randomization
measure: Diastolic blood pressure
timeFrame: 6 months post-randomization
measure: Weight
timeFrame: 6 months post-randomization
measure: Height
timeFrame: 6 months post-randomization
measure: Body mass index
timeFrame: 6 months post-randomization
measure: Waist circumference
timeFrame: 6 months post-randomization
measure: Systematic COronary Risk Evaluation model, second version (SCORE2)
timeFrame: 6 months post-randomization
measure: Health-related quality of life
timeFrame: 6 months post-randomization
measure: Health-related quality of life
timeFrame: 6 months post-randomization
measure: Diet intake
timeFrame: 6 months post-randomization
measure: Physical activity
timeFrame: 6 months post-randomization
measure: Sedentary time
timeFrame: 6 months post-randomization
measure: Stress
timeFrame: 6 months post-randomization
measure: Sleep
timeFrame: 6 months post-randomization
measure: Alcohol consumption
timeFrame: 6 months post-randomization
measure: Tobacco use
timeFrame: 6 months post-randomization
measure: Mediated effects on behavior change
timeFrame: 6 months post-randomization
measure: Participant experience from using the digital intervention
timeFrame: 6 months post-randomization
Other outcomes:
Locations:
city: Gävle
country: Sweden
facility: Primary helathcare centers in Region Gävleborg
city: Halmstad
country: Sweden
facility: Primary healthcare centers in Region Halland
city: Linköping
country: Sweden
facility: Primay healthcare centers in Region Östergötland
city: Malmö
country: Sweden
facility: Primary healthcare centers in region Skåne
city: Umeå
country: Sweden
facility: Primary healthcare centers in Region Västerbotten
city: Västerås
country: Sweden
facility: Primary healthcare centers in Region Västmanland
Study officials:
affiliation: Karolinska Institutet
name: Marie Löf, PhD
role: PRINCIPAL_INVESTIGATOR
References: