Health BehaviorsNCT04912739
Targeted Health Dialogues in Primary Care
An observational study of Health Behaviors and Risk Factors, run by Region Skane at 1 site in Sweden.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 40 to 70 years
- Conditions the study is for
- Health Behaviors, Risk Factors, Cardiovascular Diseases
- What is being tested?
- Targeted health dialogues
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 18,000 participants
- Where
- 1 siteSweden
- Study dates
- 1 Oct 2020to 31 Dec 2040
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 70 years
- All sexes
- Adult, Older adult
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.
Who may be able to join
- 40-, 50-, 60-, and 70-year old men and women
- Listed at a healthcare center in Skåne county
Who cannot join
- Inability to understand the written study information and give informed consent
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Hanna Glock, MD, PhD contact
Sweden1 site, 1 recruiting
- Recruiting
Center for Primary Health Care Research, Lund University and Region Skåne
Malmö, Skåne County, 20502
Kristina Sundquist, PhD, MD, +46 (0)40 391 376, kristina.sundquist@med.lu.se
Hanna Glock, PhD, MD, hanna.glock@med.lu.se
About this study
Official title: 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.
Read the 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.
- Being tested
- Targeted health dialogues
- Medical subject headings
- Health Behavior, Cardiovascular Diseases, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Targeted health dialoguesBehavioural
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 2035
Secondary outcomes (14)
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)
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 2035
Associations between dental and general health
Associations between dental health at baseline and incidence of CVD, cancer, other serious diseases and preterm death.
Measured: 2035
Validation of the targeted health dialogue method
Validity and reliability of the questionnaire and targeted health dialogue method
Measured: 2035
Health economy
Costs related to the targeted health dialogues versus individual and societal gains.
Measured: 2035
The effect of targeted health dialogues on health behaviors and self-rated health
Measured: 2035
Do targeted health dialogues reach all societal groups?
Measured: 2035
Can other lifestyle interventions influence the effect of targeted health dialogues?
Measured: 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?
Measured: 2035
Do the the targeted health dialogues influence care seeking?
Evaluation of new search patterns due to the targeted health dialogues.
Measured: 2035
Obstacles and motivators for physical activity
What obstacles and motivators for physical activity do inactive people experience?
Measured: 2035
Effect of targeted health dialogues on blood metabolites
Do targeted health dialogues affect food-related metabolites in the blood?
Measured: 2035
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2021
- Study start1 Oct 2020
- Primary completion31 Dec 2030 (estimated)
- Study completion31 Dec 2040 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Health BehaviorsStudies of the same condition, open and under way.
- More trials run by Region SkaneThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 18,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Region Skane
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Kristina Sundquist, PhD, MD, Principal investigator, Center for Primary Health Care Research, Department of Clinical Sciences Malmö, Lund University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04912739
- Sponsor's protocol ID
- 2020-02689
- Status last verified
- Oct 2026
- First submitted
- 23 Apr 2021
- Last updated
- 29 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Nymberg P, Milos-Nymberg V, Grundberg A, Oscarson N, Stenman E, Sundquist K. Exploring the link between self-rated poor oral health and cardiovascular risk: a cross-sectional study using SCORE2. BMC Oral Health. 2025 Feb 24;25(1):298. doi: 10.1186/s12903-025-05671-6.
PubMed 39994610Stenman E, Borgstrom Bolmsjo B, Grundberg A, Sundquist K. Health determinants among participants in targeted health dialogues offered to all 40-year-old individuals in a metropolitan region of 1.4 million people. Scand J Prim Health Care. 2025 Mar;43(1):24-35. doi: 10.1080/02813432.2024.2385547. Epub 2024 Aug 1.
PubMed 39091122
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Targeted Health Dialogues in Primary Care: Lifestyle Screening and Molecular Profiling for a Healthier Life
- ClinicalTrials.gov ID
- NCT04912739
- Acronym / sponsor ID
- 2020-02689
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 18,000 participants (estimated)
- Lead sponsor
- Region SkaneUniversity, hospital or other
- Study start
- 1 Oct 2020 (actual)
- Primary completion
- 31 Dec 2030 (estimated)
- Study completion
- 31 Dec 2040 (estimated)
- First posted
- 3 Jun 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 40 to 70 years
- Sex
- All
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- 40-, 50-, 60-, and 70-year old men and women
- Listed at a healthcare center in Skåne county
Key exclusion criteria (1 listed)
- Inability to understand the written study information and give informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Targeted health dialoguesBefore 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. | Behavioural | – |
Primary outcome
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.
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.
14 secondary outcomes
Modification by individual characteristics
Time frame: 2035
Association between risk factors and disease incidence
Time frame: 2035
Identification of molecular biomarkers
Time frame: 2035
Public health profile of middle-aged citizens in Sweden's southernmost county
Time frame: 2035
Associations between dental and general health
Time frame: 2035
Validation of the targeted health dialogue method
Time frame: 2035
Health economy
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.
Time frame: 2035
Do the the targeted health dialogues influence care seeking?
Time frame: 2035
Obstacles and motivators for physical activity
Time frame: 2035
Effect of targeted health dialogues on blood metabolites
Time frame: 2035
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2026.
- Derived from this study: PubMed 39994610Nymberg P, Milos-Nymberg V, Grundberg A, Oscarson N, Stenman E, Sundquist K. Exploring the link between self-rated poor oral health and cardiovascular risk: a cross-sectional study using SCORE2. BMC Oral Health. 2025 Feb 24;25(1):298. doi: 10.1186/s12903-025-05671-6.
- Derived from this study: PubMed 39091122Stenman E, Borgstrom Bolmsjo B, Grundberg A, Sundquist K. Health determinants among participants in targeted health dialogues offered to all 40-year-old individuals in a metropolitan region of 1.4 million people. Scand J Prim Health Care. 2025 Mar;43(1):24-35. doi: 10.1080/02813432.2024.2385547. Epub 2024 Aug 1.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Hanna Glock, MD, PhD contact
Kristina Sundquist, PhD, MD principal investigator
Center for Primary Health Care Research, Department of Clinical Sciences Malmö, Lund University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Health Behaviors and Risk Factors, run by Region Skane at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 29 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Kristina Sundquist, PhD, MD (+46 (0)40 391 376, kristina.sundquist@med.lu.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effect of targeted health dialogues on CVD incidence (time frame: 2035). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04912739, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Oct 2026.