A Digital Lifestyle Intervention in Primary Healthcare to Prevent Cardiovascular Disease

NCT ID: NCT06847633

Last Updated: 2025-05-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

1000 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-03-03

Study Completion Date

2027-06-30

Brief Summary

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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.

Detailed Description

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Conditions

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Cardiovascular Diseases Lifestyle Factors

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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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.

Group Type EXPERIMENTAL

Digital lifestyle intervention

Intervention Type 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

Control arm

Standard care i.e., a routine appointment to the primary healthcare center for discussing lifestyle habits

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

39 Years

Maximum Eligible Age

61 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Capio Narsjukvard

UNKNOWN

Sponsor Role collaborator

Karolinska Institutet

OTHER

Sponsor Role lead

Responsible Party

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Marie Löf, docent

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Marie Löf, PhD

Role: PRINCIPAL_INVESTIGATOR

Karolinska Institutet

Locations

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Primary helathcare centers in Region Gävleborg

Gävle, , Sweden

Site Status NOT_YET_RECRUITING

Primary healthcare centers in Region Halland

Halmstad, , Sweden

Site Status RECRUITING

Primay healthcare centers in Region Östergötland

Linköping, , Sweden

Site Status NOT_YET_RECRUITING

Primary healthcare centers in region Skåne

Malmo, , Sweden

Site Status RECRUITING

Primary healthcare centers in Region Västerbotten

Umeå, , Sweden

Site Status NOT_YET_RECRUITING

Primary healthcare centers in Region Västmanland

Västerås, , Sweden

Site Status RECRUITING

Countries

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Sweden

Central Contacts

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Linnea Hedin, PhD

Role: CONTACT

+4670-2473149

Facility Contacts

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Role: primary

+46702473149

Other Identifiers

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2024-07911-01

Identifier Type: -

Identifier Source: org_study_id

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