Targeted Health Dialogues in Primary Care

August 12, 2026 updated by: Region Skane

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
18000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Sweden
    • Skåne County
      • Malmö, Skåne County, Sweden, 20502
        • Recruiting
        • Center for Primary Health Care Research, Lund University and Region Skåne
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

40 years to 60 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
2035
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.
2035

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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)
2035
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.
2035
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.
2035
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.
2035
Validation of the targeted health dialogue method
Time Frame: 2035
Validity and reliability of the questionnaire and targeted health dialogue method
2035
Health economy
Time Frame: 2035
Costs related to the targeted health dialogues versus individual and societal gains.
2035
The effect of targeted health dialogues on health behaviors and self-rated health
Time Frame: 2035
2035
Do targeted health dialogues reach all societal groups?
Time Frame: 2035
2035
Can other lifestyle interventions influence the effect of targeted health dialogues?
Time Frame: 2035
2035
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.
2035
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?
2035
Do the the targeted health dialogues influence care seeking?
Time Frame: 2035
Evaluation of new search patterns due to the targeted health dialogues.
2035
Obstacles and motivators for physical activity
Time Frame: 2035
What obstacles and motivators for physical activity do inactive people experience?
2035
Effect of targeted health dialogues on blood metabolites
Time Frame: 2035
Do targeted health dialogues affect food-related metabolites in the blood?
2035

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Region Skane

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Kristina Sundquist, PhD, MD, Center for Primary Health Care Research, Department of Clinical Sciences Malmö, Lund University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 1, 2020

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2030

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2040

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 23, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 31, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 3, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 13, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 12, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2020-02689

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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