A Digital Lifestyle Intervention in Primary Healthcare to Prevent Cardiovascular Disease
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Digital lifestyle intervention.
- Who it may be relevant to
- Registry conditions: Cardiovascular Diseases, Lifestyle Factors. Basic parameters: 39 years — 61 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Sweden
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
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.
Interventions
- 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
Primary outcome measures
- LDL-cholesterol [Time frame: 6 months post-randomization]
Secondary outcome measures (12)
- HDL-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 [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) [Time frame: 6 months post-randomization]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Prevention
Study locations
Sweden · 6 centers
- Primary helathcare centers in Region Gävleborg — Gävle
- Primary healthcare centers in Region Halland — Halmstad
- Primay healthcare centers in Region Östergötland — Linköping
- Primary healthcare centers in region Skåne — Malmö
- Primary healthcare centers in Region Västerbotten — Umeå
- Primary healthcare centers in Region Västmanland — Västerås
Identifiers
NCT: NCT06847633 · 2024-07911-01 · 2025-07793