An observational study in Health Behaviors, Risk Factors and Cardiovascular Diseases, sponsored by Region Skane. Recruiting at 1 site in Sweden. Open to participants aged 40 Years to 70 Years. Per ClinicalTrials.gov, last updated 2026-09-29.
Sponsored by Region Skane · Observational
The County Council of Region Skåne, Sweden, has recently initiated Targeted Health Dialogues in primary care. The prevention program includes health dialogues provided by specially trained personnel, collection of clinical and laboratory data as well as questionnaire data on, e.g., individual health and health behaviors. So far, it enrolls all 40-year old Swedish and foreign-born inhabitants in the county and it will also include all 50- and 60-year old persons within a near future. A research project will be integrated within the program where the collected data will be linked, on the individual level, to national and regional data on hospital admissions, clinical diagnoses from specialist clinics and primary care, causes of death, and prescriptions. The individual linkages will also include population data on sociodemographic characteristics, neighborhood of residence and family relations. Blood samples will be collected for analyses of molecular biomarkers. The research project will examine associations between potential predictors and future risk of cardiovascular diseases and other serious diseases, such as cancer, and also whether the effect of the prevention program is modified by these potential predictors. The effect of the intervention will be examined, and whether the protocol needs to be modified in order to develop more precise and personalized medicine.
The County Council of Region Skåne, the third most populous region in Sweden with 1.4 million inhabitants, has recently initiated Targeted Health Dialogues in primary care with the ultimate goal to improve cardiovascular health in the entire population in Skåne. Targeted health dialogues have previously been proven to improve health behaviors and risk factors and decrease the incidence of cardiovascular disease and mortality. The prevention program includes, in addition to the health dialogues provided by specially trained personnel, collection of clinical and laboratory data (e.g. blood pressure, BMI, waist hip ratio, lipids, fasting blood glucose) as well as detailed questionnaire data on, e.g., individual health and symptoms, family history, diet, physical activity, alcohol and smoking. So far, it enrolls all 40-year old Swedish and foreign-born inhabitants in the county and it will also include all 50- and 60-year old persons within a near future. The County Council and the Ethical Review Board have granted permission to integrate a research project within the program where collected data will be linked, at the individual level, to national and regional data on hospital admissions, clinical diagnoses from specialist clinics and primary care, causes of death, and prescriptions. The individual linkages will also include population data on sociodemographic characteristics, neighborhood of residence and family relations. In addition to the collection and linkages of these data, blood samples will be collected for analyses of molecular biomarkers. The research project will allow for examining associations between a number of potential predictors and future risk of cardiovascular disease and other serious diseases, such as cancer, and also whether the effect of the prevention program is modified by these potential predictors. The effect of the intervention will be examined and whether the protocol needs to be modified in order to develop more precise and personalized medicine.
In Sweden, most people are listed at one healthcare center. The study population consists of all listed 40-, 50-, 60-year, and 70-year-old patients that perform a targeted health dialogue and consent to take part in the research study.
Exclusion Criteria:
* Inability to understand the written study information and give informed consent
Before the targeted health dialogue, the participants fill in a questionnaire about health behaviors, background characteristics and self-rated health. Samples for blood glucose and total cholesterol are taken. BMI, waist-to-hip ratio and blood pressure are measured. The results are summoned in a "health curve", which is discussed with specially trained healthcare personnel in a Targeted heath dialogue. In a sub-group, blood samples are collected for molecular analyses.
Effect of targeted health dialogues on CVD incidence
The short- and long-term effect of targeted health dialogues on incidence of CVD events, its comorbidity and CVD-related deaths in the participants compared to a general population cohort and historical controls.
Time frame: 2035
Effect of targeted health dialogues on incidence of cancer and other serious diseases
The short- and long-term effect of targeted health dialogues on incidence of cancer and other serious diseases in the participants compared to a general population cohort and historical controls.
Time frame: 2035
Modification by individual characteristics
Modification of possible associations between targeted health dialogues and future CVD, cancer, other serious diseases and preterm death by individual characteristics (e.g., sociodemographic factors)
Time frame: 2035
Association between risk factors and disease incidence
Associations between risk factors/combination of risk factors (lifestyle-related, metabolic, psychosocial and familial) at baseline and incidence of CVD, cancer, other serious diseases and preterm death.
Time frame: 2035
Identification of molecular biomarkers
The ability of biological aging, epigenetic changes and genetic and metabolomic profiles to predict CVD, cancer, other serious diseases and preterm death as well as the effect of targeted health dialogues.
Time frame: 2035
Public health profile of middle-aged citizens in Sweden's southernmost county
Level of physical activity and sedentary behavior, intake of healthy/unhealthy food, alcohol consumption, smoking habits, stress, psychological well-being, blood glucose, cholesterol, BMI, waist-hip ratio. Comparisons between subgroups: age, sex, sociodemography, previous diagnoses.
Time frame: 2035
Associations between dental and general health
Associations between dental health at baseline and incidence of CVD, cancer, other serious diseases and preterm death.
Time frame: 2035
Validation of the targeted health dialogue method
Validity and reliability of the questionnaire and targeted health dialogue method
Time frame: 2035
Health economy
Costs related to the targeted health dialogues versus individual and societal gains.
Time frame: 2035
The effect of targeted health dialogues on health behaviors and self-rated health
Time frame: 2035
Do targeted health dialogues reach all societal groups?
Time frame: 2035
Can other lifestyle interventions influence the effect of targeted health dialogues?
Time frame: 2035
Follow-up of samples taken after the targeted health dialogues.
Which samples and tests were taken as a result of the targeted health dialogues?
Time frame: 2035
Do the the targeted health dialogues influence care seeking?
Evaluation of new search patterns due to the targeted health dialogues.
Time frame: 2035
Obstacles and motivators for physical activity
What obstacles and motivators for physical activity do inactive people experience?
Time frame: 2035
Effect of targeted health dialogues on blood metabolites
Do targeted health dialogues affect food-related metabolites in the blood?
Time frame: 2035
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Region Skane