A Digital Lifestyle Intervention in Primary Healthcare to Prevent Cardiovascular Disease

Not Applicable

Recruiting

• Conditions: Cardiovascular Diseases; Lifestyle Factors

• Registration Number: NCT06847633
• Lead Sponsor: Karolinska Institutet

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2025-02-21
• Study First Submitted QC: 2025-02-21
• Study First Posted: 2025-02-26
• Study Start: 2025-03-03
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-17
• Last Update Posted: 2025-05-21
• Primary Completion: 2027-03
• Study Completion: 2027-06

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 1000

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
LDL-cholesterol	6 months post-randomization	Low density lipoprotein cholesterol

Secondary Outcome Measures

Name	Time	Method
Height	6 months post-randomization
Sedentary time	6 months post-randomization	One question about time in sitting position
Stress	6 months post-randomization	Assessed by the Perceived Stress Scale. Minimum value 0. Maximum value 56. Higher scores indicating greater perceived stress.
Sleep	6 months post-randomization	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
Weight	6 months post-randomization
HDL-cholesterol	6 months post-randomization	High density lipoprotein cholesterol
Total cholesterol	6 months post-randomization
Fasting blood glucose	6 months post-randomization
Triglycerides	6 months post-randomization
Non-HDL cholesterol	6 months post-randomization	Calculated by subtracting HDL cholesterol from total cholesterol
Systolic blood pressure	6 months post-randomization
Diastolic blood pressure	6 months post-randomization
Health-related quality of life	6 months post-randomization	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.
Diet intake	6 months post-randomization	Assessed by questions on intake quantity of vegetables, fruit, sweet beverages, and snacks the past week
Physical activity	6 months post-randomization	Assessed by questions on time (minutes and hours) spent in moderate and vigorous physical activity the past week
Body mass index	6 months post-randomization
Waist circumference	6 months post-randomization
Systematic COronary Risk Evaluation model, second version (SCORE2)	6 months post-randomization	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
Alcohol consumption	6 months post-randomization	Questions on monthly frequency of heavy episodic drinking, weekly alcohol consumption
Tobacco use	6 months post-randomization	Questions on frequency of smoking and using snus the past week and the past 4 weeks
Mediated effects on behavior change	6 months post-randomization	Potential mediators to be assessed are confidence, importance, and know-how (i.e., knowing how to change a behavior).
Participant experience from using the digital intervention	6 months post-randomization	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'

Trial Locations

Locations (6)

Primary helathcare centers in Region Gävleborg; 🇸🇪 Gävle, Sweden

Primary healthcare centers in Region Halland; 🇸🇪 Halmstad, Sweden

Primay healthcare centers in Region Östergötland; 🇸🇪 Linköping, Sweden

Primary healthcare centers in region Skåne; 🇸🇪 Malmö, Sweden

Primary healthcare centers in Region Västerbotten; 🇸🇪 Umeå, Sweden

Primary healthcare centers in Region Västmanland; 🇸🇪 Västerås, Sweden