Digital lifestyle intervention to prevent cardiovascular disease
A Digital Lifestyle Intervention in Primary Healthcare to Prevent Cardiovascular Disease
This study tests if a digital program can help people aged 40-60 in Sweden make healthier lifestyle choices to prevent heart disease.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 1000 (estimated) |
| Ages | 39 Years to 61 Years |
| Sex | All |
| Sponsor | Karolinska Institutet Academic / other |
| Locations | 6 sites (Gävle and 5 other locations) |
| Trial ID | NCT06847633 on ClinicalTrials.gov |
What this trial studies
This project evaluates a digital lifestyle intervention designed to improve cardiovascular health outcomes and lifestyle behaviors among patients aged 40-60 in Swedish primary healthcare. Participants will be randomized into either a control group receiving standard care or an intervention group receiving the digital lifestyle program. The intervention aims to leverage digital tools to support healthier lifestyle choices and ensure sustained implementation within the healthcare system. The study will assess the effectiveness of this approach in a multi-center randomized controlled trial format.
Who should consider this trial
Good fit: Ideal candidates are patients aged 40-60 who are willing to change at least one lifestyle behavior related to physical activity, diet, smoking, alcohol, sleep, or stress.
Not a fit: Patients with diabetes, heart failure, a history of myocardial infarction, a history of stroke, or those who are pregnant may not benefit from this study.
Why it matters
Potential benefit: If successful, this intervention could significantly reduce the risk of cardiovascular disease by promoting healthier lifestyle choices among patients.
How similar studies have performed: Other studies have shown success with digital lifestyle interventions in improving health outcomes, indicating that this approach is promising and not entirely novel.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Gävle and 5 other locations
- Primary helathcare centers in Region Gävleborg — Gävle, Sweden (Not_yet_recruiting)
- Primary healthcare centers in Region Halland — Halmstad, Sweden (Recruiting)
- Primay healthcare centers in Region Östergötland — Linköping, Sweden (Not_yet_recruiting)
- Primary healthcare centers in region Skåne — Malmö, Sweden (Recruiting)
- Primary healthcare centers in Region Västerbotten — Umeå, Sweden (Not_yet_recruiting)
- Primary healthcare centers in Region Västmanland — Västerås, Sweden (Recruiting)
Study contacts
- Principal investigator: Marie Löf, PhD — Karolinska Institutet
- Study coordinator: Linnea Hedin, PhD
- Email: linnea.hedin@ki.se
- Phone: +4670-2473149
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.