NCT Number: NCT06847633
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.
Interested in participating?
Request Info39 year–61 year
All sexes
Interventional
Not applicable
Primary helathcare centers in Region Gävleborg, Gävle, Sweden
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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
Time frame: 6 months post-randomization
Low density lipoprotein cholesterol
Time frame: 6 months post-randomization
High density lipoprotein cholesterol
Time frame: 6 months post-randomization
Time frame: 6 months post-randomization
Time frame: 6 months post-randomization
Time frame: 6 months post-randomization
Calculated by subtracting HDL cholesterol from total cholesterol
Time frame: 6 months post-randomization
Time frame: 6 months post-randomization
Time frame: 6 months post-randomization
Time frame: 6 months post-randomization
Time frame: 6 months post-randomization
Time frame: 6 months post-randomization
Time frame: 6 months post-randomization
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
Time frame: 6 months post-randomization
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'
Time frame: 6 months post-randomization
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.
Time frame: 6 months post-randomization
Assessed by questions on intake quantity of vegetables, fruit, sweet beverages, and snacks the past week
Time frame: 6 months post-randomization
Assessed by questions on time (minutes and hours) spent in moderate and vigorous physical activity the past week
Time frame: 6 months post-randomization
One question about time in sitting position
Time frame: 6 months post-randomization
Assessed by the Perceived Stress Scale. Minimum value 0. Maximum value 56. Higher scores indicating greater perceived stress.
Time frame: 6 months post-randomization
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
Time frame: 6 months post-randomization
Questions on monthly frequency of heavy episodic drinking, weekly alcohol consumption
Time frame: 6 months post-randomization
Questions on frequency of smoking and using snus the past week and the past 4 weeks
Time frame: 6 months post-randomization
Potential mediators to be assessed are confidence, importance, and know-how (i.e., knowing how to change a behavior).
Time frame: 6 months post-randomization
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'
Contact information is provided by the study sponsor or research team.
Karolinska Institutet
Other
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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