A Digital Lifestyle Intervention in Primary Healthcare to Prevent Cardiovascular Disease

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 Overview

• Status: Recruiting
• Conditions: Cardiovascular Diseases; Lifestyle Factors
• Intervention / Treatment: Behavioral: Digital lifestyle intervention

• Study Type: Interventional
• Enrollment (Estimated): 1000
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Linnea Hedin, PhD; Phone Number: +4670-2473149; Email: linnea.hedin@ki.se

Study Locations

• Sweden
  • Gävle, Sweden
    • Not yet recruiting
    • Primary helathcare centers in Region Gävleborg
  • Halmstad, Sweden
    • Recruiting
    • Primary healthcare centers in Region Halland
  • Linköping, Sweden
    • Not yet recruiting
    • Primay healthcare centers in Region Östergötland
  • Malmö, Sweden
    • Recruiting
    • Primary healthcare centers in region Skåne
    • Contact: Phone Number: +46702473149
  • Umeå, Sweden
    • Not yet recruiting
    • Primary healthcare centers in Region Västerbotten
  • Västerås, Sweden
    • Recruiting
    • Primary healthcare centers in Region Västmanland

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control arm; Standard care i.e., a routine appointment to the primary healthcare center for discussing lifestyle habits
Experimental: Digital lifestyle intervention; 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.	Behavioral: Digital lifestyle intervention; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
LDL-cholesterol	Low density lipoprotein cholesterol	6 months post-randomization

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
HDL-cholesterol	High density lipoprotein cholesterol	6 months post-randomization
Total cholesterol		6 months post-randomization
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
Sedentary time	One question about time in sitting position	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
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
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
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
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
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

Collaborators and Investigators

• Sponsor: Karolinska Institutet
• Collaborators: Capio Narsjukvard
• Investigators: Principal Investigator: Marie Löf, PhD, Karolinska Institutet

Study record dates

Study Major Dates

• Study Start (Actual): March 3, 2025
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): June 1, 2027

Study Registration Dates

• First Submitted: February 21, 2025
• First Submitted That Met QC Criteria: February 21, 2025
• First Posted (Actual): February 26, 2025

Study Record Updates

• Last Update Posted (Actual): May 21, 2025
• Last Update Submitted That Met QC Criteria: May 17, 2025
• Last Verified: May 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases
• Other Study ID Numbers: 2024-07911-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No