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| ID | Type | Description | Link |
|---|---|---|---|
| 2025-07793 | Other Grant/Funding Number | Swedish research council |
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| Name | Class |
|---|---|
| Capio Narsjukvard | UNKNOWN |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Digital lifestyle intervention | Experimental | 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. |
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| Control arm | No Intervention | Standard care i.e., a routine appointment to the primary healthcare center for discussing lifestyle habits |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| LDL-cholesterol | Low density lipoprotein cholesterol | 6 months post-randomization |
| Measure | Description | Time Frame |
|---|---|---|
| HDL-cholesterol | High density lipoprotein cholesterol | 6 months post-randomization |
| Total cholesterol | 6 months post-randomization | |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Linnea Hedin, PhD | Contact | +4670-2473149 | linnea.hedin@ki.se |
| Name | Affiliation | Role |
|---|---|---|
| Marie Löf, PhD | Karolinska Institutet | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Primary helathcare centers in Region Gävleborg | Not yet recruiting | Gävle | Sweden | |||
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| ID | Term |
|---|---|
| D002318 | Cardiovascular Diseases |
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| Fasting blood glucose |
| 6 months post-randomization |
| Triglycerides | 6 months post-randomization |
| Non-HDL cholesterol | Calculated by subtracting HDL cholesterol from total cholesterol | 6 months post-randomization |
| Systolic blood pressure | 6 months post-randomization |
| Diastolic blood pressure | 6 months post-randomization |
| Weight | 6 months post-randomization |
| Height | 6 months post-randomization |
| Body mass index | 6 months post-randomization |
| Waist circumference | 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 | 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' | 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. | 6 months post-randomization |
| Diet intake | Assessed by questions on intake quantity of vegetables, fruit, sweet beverages, and snacks the past week | 6 months post-randomization |
| Physical activity | Assessed by questions on time (minutes and hours) spent in moderate and vigorous physical activity the past week | 6 months post-randomization |
| Sedentary time | One question about time in sitting position | 6 months post-randomization |
| Stress | Assessed by the Perceived Stress Scale. Minimum value 0. Maximum value 56. Higher scores indicating greater perceived stress. | 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 | 6 months post-randomization |
| Alcohol consumption | Questions on monthly frequency of heavy episodic drinking, weekly alcohol consumption | 6 months post-randomization |
| Tobacco use | Questions on frequency of smoking and using snus the past week and the past 4 weeks | 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). | 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' | 6 months post-randomization |
| Primary healthcare centers in Region Halland |
| Recruiting |
| Halmstad |
| Sweden |
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| Primay healthcare centers in Region Östergötland | Recruiting | Linköping | Sweden |
| Primary healthcare centers in region Skåne | Recruiting | Malmö | Sweden |
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| Primary healthcare centers in Region Västerbotten | Recruiting | Umeå | Sweden |
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| Primary healthcare centers in Region Västmanland | Recruiting | Västerås | Sweden |