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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Enrollment
1,000
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
Primary helathcare centers in Region Gävleborg
Gävle, Sweden
NOT_YET_RECRUITINGPrimary healthcare centers in Region Halland
Halmstad, Sweden
RECRUITINGPrimay healthcare centers in Region Östergötland
Linköping, Sweden
NOT_YET_RECRUITINGPrimary healthcare centers in region Skåne
Malmo, Sweden
RECRUITINGPrimary healthcare centers in Region Västerbotten
Umeå, Sweden
NOT_YET_RECRUITINGPrimary healthcare centers in Region Västmanland
Västerås, Sweden
RECRUITINGLDL-cholesterol
Low density lipoprotein cholesterol
Time frame: 6 months post-randomization
HDL-cholesterol
High density lipoprotein cholesterol
Time frame: 6 months post-randomization
Total cholesterol
Time frame: 6 months post-randomization
Fasting blood glucose
Time frame: 6 months post-randomization
Triglycerides
Time frame: 6 months post-randomization
Non-HDL cholesterol
Calculated by subtracting HDL cholesterol from total cholesterol
Time frame: 6 months post-randomization
Systolic blood pressure
Time frame: 6 months post-randomization
Diastolic blood pressure
Time frame: 6 months post-randomization
Weight
Time frame: 6 months post-randomization
Height
Time frame: 6 months post-randomization
Body mass index
Time frame: 6 months post-randomization
Waist circumference
Time frame: 6 months post-randomization
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
Time frame: 6 months post-randomization
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'
Time frame: 6 months post-randomization
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.
Time frame: 6 months post-randomization
Diet intake
Assessed by questions on intake quantity of vegetables, fruit, sweet beverages, and snacks the past week
Time frame: 6 months post-randomization
Physical activity
Assessed by questions on time (minutes and hours) spent in moderate and vigorous physical activity the past week
Time frame: 6 months post-randomization
Sedentary time
One question about time in sitting position
Time frame: 6 months post-randomization
Stress
Assessed by the Perceived Stress Scale. Minimum value 0. Maximum value 56. Higher scores indicating greater perceived stress.
Time frame: 6 months post-randomization
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
Time frame: 6 months post-randomization
Alcohol consumption
Questions on monthly frequency of heavy episodic drinking, weekly alcohol consumption
Time frame: 6 months post-randomization
Tobacco use
Questions on frequency of smoking and using snus the past week and the past 4 weeks
Time frame: 6 months post-randomization
Mediated effects on behavior change
Potential mediators to be assessed are confidence, importance, and know-how (i.e., knowing how to change a behavior).
Time frame: 6 months post-randomization
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'
Time frame: 6 months post-randomization
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