NCT06847633

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,000

participants targeted

Target at P75+ for not_applicable cardiovascular-diseases

Timeline
13mo left

Started Mar 2025

Geographic Reach
1 country

6 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress53%
Mar 2025Jun 2027

First Submitted

Initial submission to the registry

February 21, 2025

Completed
5 days until next milestone

First Posted

Study publicly available on registry

February 26, 2025

Completed
5 days until next milestone

Study Start

First participant enrolled

March 3, 2025

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2027

Expected
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2027

Last Updated

May 21, 2025

Status Verified

May 1, 2025

Enrollment Period

2 years

First QC Date

February 21, 2025

Last Update Submit

May 17, 2025

Conditions

Cardiovascular DiseasesLifestyle Factors

Outcome Measures

Primary Outcomes (1)

  • LDL-cholesterol

    Low density lipoprotein cholesterol

    6 months post-randomization

Secondary Outcomes (23)

  • HDL-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

    6 months post-randomization

  • +18 more secondary outcomes

Study Arms (2)

Digital lifestyle intervention

EXPERIMENTAL

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

Control arm

NO INTERVENTION

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

Interventions

Digital lifestyle interventionBEHAVIORAL

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

Digital lifestyle intervention

Eligibility Criteria

Age39 Years - 61 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • diabetes
  • heart failure
  • history of myocardial infarction
  • history of stroke
  • pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

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

Malmo, Sweden

RECRUITING

Primary healthcare centers in Region Västerbotten

Umeå, Sweden

NOT YET RECRUITING

Primary healthcare centers in Region Västmanland

Västerås, Sweden

RECRUITING

MeSH Terms

Conditions

Cardiovascular Diseases

Study Officials

  • Marie Löf, PhD

    Karolinska Institutet

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Linnea Hedin, PhD

CONTACT

+4670-2473149linnea.hedin@ki.se

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

February 21, 2025

First Posted

February 26, 2025

Study Start

March 3, 2025

Primary Completion (Estimated)

March 1, 2027

Study Completion (Estimated)

June 1, 2027

Last Updated

May 21, 2025

Record last verified: 2025-05

Data Sharing

IPD Sharing
Will not share

Locations

SE(6)