Skip to main content
OpenTrials
Recruiting

NCT Number: NCT04912739

Targeted Health Dialogues in Primary Care

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.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Health Behaviors Behavior Cancer Cardiovascular Diseases Health Behavior Neoplasms Risk Factors Serious Diseases

Age range

40 year–70 year

Sex eligibility

All sexes

Study type

Observational

Primary location

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 40-, 50-, 60-, and 70-year old men and women
  • Listed at a healthcare center in Skåne county

Exclusion criteria

  • Inability to understand the written study information and give informed consent

Treatment and study plan

Targeted health dialogues

Behavioral

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.

Primary outcomes

  1. Effect of targeted health dialogues on CVD incidence

    Time frame: 2035

    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.

  2. Effect of targeted health dialogues on incidence of cancer and other serious diseases

    Time frame: 2035

    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.

Secondary outcomes

  1. Modification by individual characteristics

    Time frame: 2035

    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)

  2. Association between risk factors and disease incidence

    Time frame: 2035

    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.

  3. Identification of molecular biomarkers

    Time frame: 2035

    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.

  4. Public health profile of middle-aged citizens in Sweden's southernmost county

    Time frame: 2035

    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.

  5. Associations between dental and general health

    Time frame: 2035

    Associations between dental health at baseline and incidence of CVD, cancer, other serious diseases and preterm death.

  6. Validation of the targeted health dialogue method

    Time frame: 2035

    Validity and reliability of the questionnaire and targeted health dialogue method

  7. Health economy

    Time frame: 2035

    Costs related to the targeted health dialogues versus individual and societal gains.

  8. The effect of targeted health dialogues on health behaviors and self-rated health

    Time frame: 2035

  9. Do targeted health dialogues reach all societal groups?

    Time frame: 2035

  10. Can other lifestyle interventions influence the effect of targeted health dialogues?

    Time frame: 2035

  11. Follow-up of samples taken after the targeted health dialogues.

    Time frame: 2035

    Which samples and tests were taken as a result of the targeted health dialogues?

  12. Do the the targeted health dialogues influence care seeking?

    Time frame: 2035

    Evaluation of new search patterns due to the targeted health dialogues.

  13. Obstacles and motivators for physical activity

    Time frame: 2035

    What obstacles and motivators for physical activity do inactive people experience?

  14. Effect of targeted health dialogues on blood metabolites

    Time frame: 2035

    Do targeted health dialogues affect food-related metabolites in the blood?

Study contacts

Contact information is provided by the study sponsor or research team.

Emelie Stenman, PhD

CONTACT

[email protected]

+46 (0)702 900 920

Kristina Sundquist, PhD, MD

CONTACT

[email protected]

+46 (0)40 391 376

Sponsors and collaborators

Lead sponsor

Region Skane

Other

Registry information

Official study title

Targeted Health Dialogues in Primary Care: Lifestyle Screening and Molecular Profiling for a Healthier Life

Important dates

Study start
2020
Primary completion
2030
Study completion
2040
First posted
Jun 3, 2021
Registry last updated
Jun 25, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.