Type-2 DiabetesNCT02797392
Feasibility of a Preventive Program Against Lifestyle Related Diseases
A study testing Lifestyle intervention in people with Type-2 Diabetes and Cardiovascular Diseases, run by University of Southern Denmark at 6 sites in 3 countries.
Trial summary
The continuously increasing prevalence of cardiovascular diseases, type-2 diabetes, and COPD is a major health problem in developed countries and is mainly caused by an unhealthy lifestyle. Read more about this study
- Who is it for?
- Ages 30 to 59 years
- Conditions the study is for
- Type-2 Diabetes, Cardiovascular Diseases, Chronic Obstructive Pulmonary Disease (COPD)
- What is being tested?
- Lifestyle intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9,400 participants
- Where
- 6 sitesin 3 countries
- Study dates
- Sep 2016to Dec 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 30 to 59 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patients listed to one of the participating GPs
- Place of residence: One of the two participating municipalities in the Region of Southern Denmark.
- Year of birth: 1957-1986
Who cannot join
- None
Trial locations and contacts
6 sites in 3 countries.
6 sites in 3 countries
Denmark4 sites
Research Programme on Health Promotion and Prevention, National Institute of Public Health, University of Southern Denmark,
Copenhagen, DK-1353
Center of Health Economics Research, Department of Business and Economics, University of Southern Denmark
Odense, DK-5230
Department of Sports Science and Clinical Biomechanics, Musculoskeletal Function and Physiotherapy, University of Southern Denmark
Odense, DK-5230
Research Unit of General Practice, Dept. of Public Health, University of Southern Denmark,
Odense C, DK-5000
Norway1 site
Research Group for Information Systems, Department of Informatics, University of Oslo
Oslo, 0373
Sweden1 site
Center for Primary Health Care Research, Department of Clinical Sciences
Malmö, SE-205 02
About this study
Official title: Early Detection and Prevention of Lifestyle Related Diseases - a Pilot Study
The continuously increasing prevalence of cardiovascular diseases, type-2 diabetes, and COPD is a major health problem in developed countries and is mainly caused by an unhealthy lifestyle. Most important lifestyle related causes of morbidity and mortality are smoking, obesity and physical inactivity, and increasing rates of obesity and physical inactivity in combination with smoking will lead to an increase in the number of patients with lifestyle related diseases in the coming decades. There is, therefore, an urgent need to identify and establish strategies and to implement interventions, allowing for the identification and management of citizens at increased risk of disease.
Two recent systematic reviews of general practice based health checks suggest that people at increased risk of a chronic disease may benefit from a targeted approach to health checks. Targeted or selective preventive actions are a generally accepted and well integrated part of the health care system (e.g. treatment of hypertension and hyperlipidemia). However, selective prevention is challenged in terms of how to identify citizens at increased risk of disease in the general population in order to start the indicated preventive actions.
Read more
The aim of the present pilot study is to test the acceptability, feasibility and short-term effect of a selective preventive program that systematically helps citizens evaluate individual risk of lifestyle related disease and offers targeted and coordinated preventive services in the primary health care sector.
The intervention comprises four elements: 1) Systematic collection of information on lifestyle risk factors using questionnaire 2) Risk estimation and stratification into risk groups based on questionnaire data and information from the electronic patient record (EPR) using validated risk estimation models, 3) An individual electronic health profile with personalized advise on lifestyle change and 4) targeted preventive services at the general practitioner (GP) or the municipality for citizens at risk of lifestyle disease and citizens with risk behavior, respectively.
The intervention is supported by a patient-centered health information system that facilitates informed patient action and integrates general practice and municipality health care providers.
Read the detailed description
Recruitment strategy:
The study is carried out in two municipalities in the Region of Southern Denmark (Haderslev and Varde municipality. Total number of inhabitants: 98.925). All general practitioners in the two municipalities (n=68) have been invited, and a total of 47 have agreed to participate in the study. A total of 200 citizens born 1957-1986 are selected from the patient list of each participating GP. Before selection, the citizens are stratified into households, and subsequently households are randomly selected until the total number of citizens per enrolled GP reaches 200. In selection of households the proportion of citizens living alone and the proportion of citizens living with one or more potential participants is taken into account. No disease-related criteria for excluding a citizen are defined prior to the study. The selected citizens are invited to participate and asked to sign a declaration of consent.
Risk stratification and preventive services offered:
Enrolled participants receive a 15-item questionnaire on lifestyle, familiar disposition of lifestyle disease and selected symptoms. From the individual electronic patient records (EPR) at the GP information on diagnoses and treatment of COPD, type-2 diabetes, hyperlipidemia, hypertension and ischemic heart disease are drawn. Based on questionnaire and EPR data the participants are stratified into four groups: 1) Citizens with an already diagnosed lifestyle related disease, 2) Citizens with an increased risk of lifestyle related disease, 3) Citizens with risk behavior and 4) Citizens with a healthy lifestyle.
Citizens in group 1 are already being treated and/or receive behavioral interventions and are therefore not the primary target of this study. Citizens in group 2 has a calculated increased risk of lifestyle related disease(s) based on validated predictive models for risk of COPD, type-2 diabetes and cardiovascular disease. The risk of COPD is calculated using the COPD-PS screener algorithm taking into account information on age, total cigarette consumption and respiratory symptoms. The risk of type-2 diabetes is calculated based on the algorithm used in the Addition study including information on age, gender, BMI, history of hypertension, physical activity and family history of diabetes. The cut-off value for being at risk of type-2 diabetes, and COPD follows the recommendations of the two models. The risk of cardiovascular disease is calculated using the Heart Score BMI score based on information about age, gender, smoking status and BMI. An increased risk of cardiovascular disease is defined in citizens with a ≥5% risk of dying of cardiovascular disease within the next 10 years. Citizens in group 2 are offered a preventive program at the GP including an initial health examination and subsequent behavior counselling. Citizens in group 3 are defined by having a BMI>35, being daily smoker, having a high risk alcohol consumption, having unhealthy eating habits and/or low physical activity. Evaluation of eating habits is based on the recommendations in the Swedish National Guidelines on Disease Prevention, and evaluation of alcohol consumption and physical activity is based on recommendations from the Danish Health Authority. Citizens in group 3 are offered behavior counselling in the municipality and community health services, if necessary. Citizens in group 4 are not offered any further services.
Electronic health information system:
The intervention is supported by a patient-centered health information system that facilitates informed patient action based on the predictive model for identification and stratification of citizens to the appropriate care providers and that supports the initiation and follow up of preventive care through the provision of health information resources, decision aids, risk calculators, personalized motivational messages and integrates primary care and municipality health care providers.
Common training course:
Before the study commences enrolled GPs, practice staff and health professionals from the municipalities are offered a common training course. The aim of the course is to train the specific intervention elements and to improve the inter-sectoral knowledge and collaboration on prevention of lifestyle diseases.
Evaluation:
Evaluation of the study will be carried out using quantitative as well as qualitative research methods. Details on evaluation methods are included in section 9.
Results of the present pilot study will be used for the adjustment of the intervention prior to a large scale study comprising 10 municipalities, up to 360 GPs and 200.000 citizens.
- Being tested
- Lifestyle intervention
- Keywords
- Tailored lifestyle intervention, Selective prevention, Primary care, Web based health risk assessment, Patient-centered health information system, Lifestyle intervention, preventive treatment
- Medical subject headings
- Cardiovascular Diseases, Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lifestyle interventionBehavioural
- Systematic collection of information on lifestyle risk factors using questionnaire 2) Risk estimation and stratification into risk groups based on questionnaire data and information from the electronic patient record (EPR) using validated risk estimation models, 3) An individual electronic health profile with personalized advise on lifestyle change and 4) targeted preventive services incl. lifestyle counseling at the GP or the municipality for citizens at increased risk of lifestyle disease and citizens with risk behavior, respectively.
| Study group | Role | What they receive |
|---|---|---|
| Lifestyle intervention | Experimental | All included citizens receive a questionnaire to estimate risk of disease and risk behavior. Information about lifestyle is collated with existing Electronic Patient Record (EPR) data and the citizen's risk of lifestyle-related disease is estimated based on validated algorithms for risk of type-2 diabetes, cardiovascular disease and COPD (Stratification). All citizens receive an electronic health profile and targeted advice. Citizens at increased risk of disease are offered a preventive program at the GP including an initial health examination and subsequent lifestyle counselling. Citizens with risk behavior are offered lifestyle counselling in the municipality and community health services, if necessary. Citizens diagnosed with a lifestyle related disease are already being treated by the GP, and therefore, like citizens with a healthy lifestyle, they are not offered any further services. Receives: Behavioral: Lifestyle intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in proportion of citizens at increased risk of lifestyle related disease from baseline to the 12 weeks follow up
Questionnaire. Risk of lifestyle related disease is estimated based on the validated algorithms described under Detailed Study Description
Measured: At baseline and within 1 month following the 12 weeks study period.
Secondary outcomes (15)
Evaluation of the patient centered health information system with focus on design, usability and effect of the decision support system.
Focus group interviews within three months before study start. The focus groups comprise 6 GPs and 2 practice staff members, 9 municipality staff members, 9 citizens and representatives from 6 stakeholder organizations, respectively.
Observational studies focusing on 6-8 citizens during the 12 weeks study period with focus on all situations where the health information system is used (at home, at the GPs, etc.).
Questionnaire to all participating citizens within 1 month following the 12 weeks study period and to all participating GPs and municipality staff members following each study related patient encounter.
Measured: Three months before the study period, ongoing during the 12 weeks study period and within one month following the 12 weeks study period, respectively.
Process evaluation focusing on the intervention in general practice.
Observational studies during 10-15 behavior counseling sessions in different general practices, followed by qualitative interviews with the participating citizens, GPs and practice staff.
Questionnaire to all participating GPs and practice staff members following each study related patient encounter.
Measured: Ongoing during the 12 weeks study period
Quality of Life Subscale on the Hip injury and Osteoarthritis Outcome Score (HOOS)/Knee Injury and Osteoarthritis Outcome Score (KOOS)
Participants replying "yes" to any of the osteoarthritis related questions on hip/knee pain, GP care seeking or surgery at baseline will receive additional questions on knee/hip related quality of life.
Measured: At baseline
Patient enablement following the behavior counselling session at the GP.
Questionnaire incl. Patient Enablement Instrument (PEI)
Measured: Within one week following each behavior counselling session at the GP.
Patient reported self-efficacy
Questionnaire incl. The General Self-Efficacy Scale
Measured: At baseline
Patient reported mental well-being.
Questionnaire incl. The short Warwick-Edinburgh Mental Well-being Scale (SWEMWBS)
Measured: At baseline and within 1 month following the 12 weeks study period.
Process evaluation focusing on the common training course for enrolled GPs, practice staff and health professionals from the municipalities.
Observational studies during the common training course and questionnaire at the end of the course.
Measured: The common training course before study start.
GPs and the citizens preferences with regard to the content of the behavior counselling session, and change in preferences from baseline to the 12 weeks follow up.
Questionnaire using discrete choice modelling.
Measured: At baseline and within 1 month following the 12 weeks study period.
Patients' perceptions of relational empathy following the behavior counselling session at the GP.
Questionnaire including The Consultation And Relational Empathy (CARE) measure.
Measured: Within one week following each behavior counselling session at the GP.
Patient reported Meaning-Making and Health
Questionnaire with items sampled from the validated questionnaire SoMe (Sources of Meaning)
Measured: Within 1 month following the 12 weeks study period.
Patient reported Spiritual Wellbeing
Questionnaire including the validated FACITSp scale
Measured: Within 1 month following the 12 weeks study period.
Patient reported Religious belief and practices
Questionnaire with items sampled from the validated questionnaire European Value Study (EVS)
Measured: Within 1 month following the 12 weeks study period
GP reported perceived importance of communication on existential and spiritual issues
Questionnaire with two tested items developed for this study
Measured: Within 1 month following the 12 weeks study period.
GP reported Self-efficacy and barriers in communication on existential and spiritual issues
Questionnaire with items sampled from the validated Self-efficacy questionnaire
Measured: Within 1 month following the 12 weeks study period.
GP reported Personal belief
Questionnaire with items sampled from the validated questionnaire European Value Study (EVS)
Measured: Within 1 month following the 12 weeks study period.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jun 2016 (estimated)
- Study startSep 2016
- Primary completion28 Feb 2017
- Study completionDec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (14)Papers the sponsor has linked to this study.
- Other trials for Type-2 DiabetesStudies of the same condition, open and under way.
- More trials run by University of Southern DenmarkThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 9,400 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Southern Denmark
- Sponsor type
- University, hospital or other
- Collaborators
- University of Oslo, Lund University
- Responsible party
- Principal investigator, Trine Thilsing, University of Southern Denmark
- Investigators
- Jens Søndergaard, Principal investigator, Research Unit of General Practice, Dept. of Public Health, University of Southern Denmark, DK-5000 Odense C, Denmark
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02797392
- Sponsor's protocol ID
- TOFpilot2016
- Other IDs
- 11/13244, 15/10562, 14/43732., 2015-57-0008
- Status last verified
- Apr 2019
- First submitted
- 29 Apr 2016
- Last updated
- 29 Apr 2019
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
James WP. The epidemiology of obesity: the size of the problem. J Intern Med. 2008 Apr;263(4):336-52. doi: 10.1111/j.1365-2796.2008.01922.x. Epub 2008 Feb 27.
PubMed 18312311King H, Aubert RE, Herman WH. Global burden of diabetes, 1995-2025: prevalence, numerical estimates, and projections. Diabetes Care. 1998 Sep;21(9):1414-31. doi: 10.2337/diacare.21.9.1414.
PubMed 9727886Yusuf S, Reddy S, Ounpuu S, Anand S. Global burden of cardiovascular diseases: part I: general considerations, the epidemiologic transition, risk factors, and impact of urbanization. Circulation. 2001 Nov 27;104(22):2746-53. doi: 10.1161/hc4601.099487.
PubMed 11723030Si S, Moss JR, Sullivan TR, Newton SS, Stocks NP. Effectiveness of general practice-based health checks: a systematic review and meta-analysis. Br J Gen Pract. 2014 Jan;64(618):e47-53. doi: 10.3399/bjgp14X676456.
PubMed 24567582Engelsen Cd, Koekkoek PS, Godefrooij MB, Spigt MG, Rutten GE. Screening for increased cardiometabolic risk in primary care: a systematic review. Br J Gen Pract. 2014 Oct;64(627):e616-26. doi: 10.3399/bjgp14X681781.
PubMed 25267047Martinez FJ, Raczek AE, Seifer FD, Conoscenti CS, Curtice TG, D'Eletto T, Cote C, Hawkins C, Phillips AL; COPD-PS Clinician Working Group. Development and initial validation of a self-scored COPD Population Screener Questionnaire (COPD-PS). COPD. 2008 Apr;5(2):85-95. doi: 10.1080/15412550801940721.
PubMed 18415807Christensen JO, Sandbaek A, Lauritzen T, Borch-Johnsen K. Population-based stepwise screening for unrecognised Type 2 diabetes is ineffective in general practice despite reliable algorithms. Diabetologia. 2004 Sep;47(9):1566-73. doi: 10.1007/s00125-004-1496-2. Epub 2004 Sep 8.
PubMed 15365615Cardiology. ESo. Heartscore BMI score [Internet]. Available from: https://escol.escardio.org/heartscore/calc.aspx?model=europelow. 2014.
Socialstyrelsen. S. Sjukdomsförebyggande metoder. Vetenskabeligt underlag för nationella riktlinjer. 2011
Leick C, Larsen LB, Larrabee Sonderlund A, Svensson NH, Sondergaard J, Thilsing T. Non-participation in a targeted prevention program aimed at lifestyle-related diseases: a questionnaire-based assessment of patient-reported reasons. BMC Public Health. 2022 May 13;22(1):970. doi: 10.1186/s12889-022-13382-8.
PubMed 35562735Hansen CB, Pavlovic KMH, Sondergaard J, Thilsing T. Does GP empathy influence patient enablement and success in lifestyle change among high risk patients? BMC Fam Pract. 2020 Aug 8;21(1):159. doi: 10.1186/s12875-020-01232-8.
PubMed 32770946Thilsing T, Sonderlund AL, Sondergaard J, Svensson NH, Christensen JR, Thomsen JL, Hvidt NC, Larsen LB. Changes in Health-Risk Behavior, Body Mass Index, Mental Well-Being, and Risk Status Following Participation in a Stepwise Web-Based and Face-to-Face Intervention for Prevention of Lifestyle-Related Diseases: Nonrandomized Follow-Up Cohort Study. JMIR Public Health Surveill. 2020 Jul 9;6(3):e16083. doi: 10.2196/16083.
PubMed 32673269Larsen LB, Thilsing T, Pedersen LB. Patient preferences for preventive health checks in Danish general practice: a discrete choice experiment among patients at high risk of noncommunicable diseases. Fam Pract. 2020 Oct 19;37(5):689-694. doi: 10.1093/fampra/cmaa038.
PubMed 32311022van Tunen JAC, Peat G, Bricca A, Larsen LB, Sondergaard J, Thilsing T, Roos EM, Thorlund JB. Association of osteoarthritis risk factors with knee and hip pain in a population-based sample of 29-59 year olds in Denmark: a cross-sectional analysis. BMC Musculoskelet Disord. 2018 Aug 21;19(1):300. doi: 10.1186/s12891-018-2183-7.
PubMed 30126395
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Detection and Prevention of Lifestyle Related Diseases - a Pilot Study
- ClinicalTrials.gov ID
- NCT02797392
- Acronym / sponsor ID
- TOFpilot2016
- Keywords
- Tailored lifestyle intervention, Selective prevention, Primary care, Web based health risk assessment, Patient-centered health information system, Lifestyle intervention, preventive treatment
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 9,400 participants (actual)
- Lead sponsor
- University of Southern DenmarkUniversity, hospital or other
- Collaborators
- University of Oslo, Lund University
- Study start
- Sep 2016 (actual)
- Primary completion
- 28 Feb 2017 (actual)
- Study completion
- Dec 2017 (actual)
- First posted
- 13 Jun 2016 (estimated)
- 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 continuously increasing prevalence of cardiovascular diseases, type-2 diabetes, and COPD is a major health problem in developed countries and is mainly caused by an unhealthy lifestyle. Most important lifestyle related causes of morbidity and mortality are smoking, obesity and physical inactivity, and increasing rates of obesity and physical inactivity in combination with smoking will lead to an increase in the number of patients with lifestyle related diseases in the coming decades. There is, therefore, an urgent need to identify and establish strategies and to implement interventions, allowing for the identification and management of citizens at increased risk of disease.
Two recent systematic reviews of general practice based health checks suggest that people at increased risk of a chronic disease may benefit from a targeted approach to health checks. Targeted or selective preventive actions are a generally accepted and well integrated part of the health care system (e.g. treatment of hypertension and hyperlipidemia). However, selective prevention is challenged in terms of how to identify citizens at increased risk of disease in the general population in order to start the indicated preventive actions.
The aim of the present pilot study is to test the acceptability, feasibility and short-term effect of a selective preventive program that systematically helps citizens evaluate individual risk of lifestyle related disease and offers targeted and coordinated preventive services in the primary health care sector.
The intervention comprises four elements: 1) Systematic collection of information on lifestyle risk factors using questionnaire 2) Risk estimation and stratification into risk groups based on questionnaire data and information from the electronic patient record (EPR) using validated risk estimation models, 3) An individual electronic health profile with personalized advise on lifestyle change and 4) targeted preventive services at the general practitioner (GP) or the municipality for citizens at risk of lifestyle disease and citizens with risk behavior, respectively.
The intervention is supported by a patient-centered health information system that facilitates informed patient action and integrates general practice and municipality health care providers.
Detailed description
Recruitment strategy:
The study is carried out in two municipalities in the Region of Southern Denmark (Haderslev and Varde municipality. Total number of inhabitants: 98.925). All general practitioners in the two municipalities (n=68) have been invited, and a total of 47 have agreed to participate in the study. A total of 200 citizens born 1957-1986 are selected from the patient list of each participating GP. Before selection, the citizens are stratified into households, and subsequently households are randomly selected until the total number of citizens per enrolled GP reaches 200. In selection of households the proportion of citizens living alone and the proportion of citizens living with one or more potential participants is taken into account. No disease-related criteria for excluding a citizen are defined prior to the study. The selected citizens are invited to participate and asked to sign a declaration of consent.
Risk stratification and preventive services offered:
Enrolled participants receive a 15-item questionnaire on lifestyle, familiar disposition of lifestyle disease and selected symptoms. From the individual electronic patient records (EPR) at the GP information on diagnoses and treatment of COPD, type-2 diabetes, hyperlipidemia, hypertension and ischemic heart disease are drawn. Based on questionnaire and EPR data the participants are stratified into four groups: 1) Citizens with an already diagnosed lifestyle related disease, 2) Citizens with an increased risk of lifestyle related disease, 3) Citizens with risk behavior and 4) Citizens with a healthy lifestyle.
Citizens in group 1 are already being treated and/or receive behavioral interventions and are therefore not the primary target of this study. Citizens in group 2 has a calculated increased risk of lifestyle related disease(s) based on validated predictive models for risk of COPD, type-2 diabetes and cardiovascular disease. The risk of COPD is calculated using the COPD-PS screener algorithm taking into account information on age, total cigarette consumption and respiratory symptoms. The risk of type-2 diabetes is calculated based on the algorithm used in the Addition study including information on age, gender, BMI, history of hypertension, physical activity and family history of diabetes. The cut-off value for being at risk of type-2 diabetes, and COPD follows the recommendations of the two models. The risk of cardiovascular disease is calculated using the Heart Score BMI score based on information about age, gender, smoking status and BMI. An increased risk of cardiovascular disease is defined in citizens with a ≥5% risk of dying of cardiovascular disease within the next 10 years. Citizens in group 2 are offered a preventive program at the GP including an initial health examination and subsequent behavior counselling. Citizens in group 3 are defined by having a BMI>35, being daily smoker, having a high risk alcohol consumption, having unhealthy eating habits and/or low physical activity. Evaluation of eating habits is based on the recommendations in the Swedish National Guidelines on Disease Prevention, and evaluation of alcohol consumption and physical activity is based on recommendations from the Danish Health Authority. Citizens in group 3 are offered behavior counselling in the municipality and community health services, if necessary. Citizens in group 4 are not offered any further services.
Electronic health information system:
The intervention is supported by a patient-centered health information system that facilitates informed patient action based on the predictive model for identification and stratification of citizens to the appropriate care providers and that supports the initiation and follow up of preventive care through the provision of health information resources, decision aids, risk calculators, personalized motivational messages and integrates primary care and municipality health care providers.
Common training course:
Before the study commences enrolled GPs, practice staff and health professionals from the municipalities are offered a common training course. The aim of the course is to train the specific intervention elements and to improve the inter-sectoral knowledge and collaboration on prevention of lifestyle diseases.
Evaluation:
Evaluation of the study will be carried out using quantitative as well as qualitative research methods. Details on evaluation methods are included in section 9.
Results of the present pilot study will be used for the adjustment of the intervention prior to a large scale study comprising 10 municipalities, up to 360 GPs and 200.000 citizens.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Lifestyle intervention | Experimental | Behavioral: Lifestyle interventionAll included citizens receive a questionnaire to estimate risk of disease and risk behavior. Information about lifestyle is collated with existing Electronic Patient Record (EPR) data and the citizen's risk of lifestyle-related disease is estimated based on validated algorithms for risk of type-2 diabetes, cardiovascular disease and COPD (Stratification). All citizens receive an electronic health profile and targeted advice. Citizens at increased risk of disease are offered a preventive program at the GP including an initial health examination and subsequent lifestyle counselling. Citizens with risk behavior are offered lifestyle counselling in the municipality and community health services, if necessary. Citizens diagnosed with a lifestyle related disease are already being treated by the GP, and therefore, like citizens with a healthy lifestyle, they are not offered any further services. |
Who may qualify
- Ages
- 30 to 59 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Patients listed to one of the participating GPs
- Place of residence: One of the two participating municipalities in the Region of Southern Denmark.
- Year of birth: 1957-1986
Key exclusion criteria (1 listed)
- None
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 |
|---|---|---|
| Lifestyle intervention1) Systematic collection of information on lifestyle risk factors using questionnaire 2) Risk estimation and stratification into risk groups based on questionnaire data and information from the electronic patient record (EPR) using validated risk estimation models, 3) An individual electronic health profile with personalized advise on lifestyle change and 4) targeted preventive services incl. lifestyle counseling at the GP or the municipality for citizens at increased risk of lifestyle disease and citizens with risk behavior, respectively. | Behavioural | Lifestyle intervention |
Primary outcome
Change in proportion of citizens at increased risk of lifestyle related disease from baseline to the 12 weeks follow up
Time frame: At baseline and within 1 month following the 12 weeks study period.
Questionnaire. Risk of lifestyle related disease is estimated based on the validated algorithms described under Detailed Study Description
15 secondary outcomes
Evaluation of the patient centered health information system with focus on design, usability and effect of the decision support system.
Time frame: Three months before the study period, ongoing during the 12 weeks study period and within one month following the 12 weeks study period, respectively.
Process evaluation focusing on the intervention in general practice.
Time frame: Ongoing during the 12 weeks study period
Quality of Life Subscale on the Hip injury and Osteoarthritis Outcome Score (HOOS)/Knee Injury and Osteoarthritis Outcome Score (KOOS)
Time frame: At baseline
Patient enablement following the behavior counselling session at the GP.
Time frame: Within one week following each behavior counselling session at the GP.
Patient reported self-efficacy
Time frame: At baseline
Patient reported mental well-being.
Time frame: At baseline and within 1 month following the 12 weeks study period.
Process evaluation focusing on the common training course for enrolled GPs, practice staff and health professionals from the municipalities.
Time frame: The common training course before study start.
GPs and the citizens preferences with regard to the content of the behavior counselling session, and change in preferences from baseline to the 12 weeks follow up.
Time frame: At baseline and within 1 month following the 12 weeks study period.
Patients' perceptions of relational empathy following the behavior counselling session at the GP.
Time frame: Within one week following each behavior counselling session at the GP.
Patient reported Meaning-Making and Health
Time frame: Within 1 month following the 12 weeks study period.
Patient reported Spiritual Wellbeing
Time frame: Within 1 month following the 12 weeks study period.
Patient reported Religious belief and practices
Time frame: Within 1 month following the 12 weeks study period
GP reported perceived importance of communication on existential and spiritual issues
Time frame: Within 1 month following the 12 weeks study period.
GP reported Self-efficacy and barriers in communication on existential and spiritual issues
Time frame: Within 1 month following the 12 weeks study period.
GP reported Personal belief
Time frame: Within 1 month following the 12 weeks study period.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2019.
- Background: PubMed 18312311James WP. The epidemiology of obesity: the size of the problem. J Intern Med. 2008 Apr;263(4):336-52. doi: 10.1111/j.1365-2796.2008.01922.x. Epub 2008 Feb 27.
- Background: PubMed 9727886King H, Aubert RE, Herman WH. Global burden of diabetes, 1995-2025: prevalence, numerical estimates, and projections. Diabetes Care. 1998 Sep;21(9):1414-31. doi: 10.2337/diacare.21.9.1414.
- Background: PubMed 11723030Yusuf S, Reddy S, Ounpuu S, Anand S. Global burden of cardiovascular diseases: part I: general considerations, the epidemiologic transition, risk factors, and impact of urbanization. Circulation. 2001 Nov 27;104(22):2746-53. doi: 10.1161/hc4601.099487.
- Background: PubMed 24567582Si S, Moss JR, Sullivan TR, Newton SS, Stocks NP. Effectiveness of general practice-based health checks: a systematic review and meta-analysis. Br J Gen Pract. 2014 Jan;64(618):e47-53. doi: 10.3399/bjgp14X676456.
- Background: PubMed 25267047Engelsen Cd, Koekkoek PS, Godefrooij MB, Spigt MG, Rutten GE. Screening for increased cardiometabolic risk in primary care: a systematic review. Br J Gen Pract. 2014 Oct;64(627):e616-26. doi: 10.3399/bjgp14X681781.
- Background: PubMed 18415807Martinez FJ, Raczek AE, Seifer FD, Conoscenti CS, Curtice TG, D'Eletto T, Cote C, Hawkins C, Phillips AL; COPD-PS Clinician Working Group. Development and initial validation of a self-scored COPD Population Screener Questionnaire (COPD-PS). COPD. 2008 Apr;5(2):85-95. doi: 10.1080/15412550801940721.
- Background: PubMed 15365615Christensen JO, Sandbaek A, Lauritzen T, Borch-Johnsen K. Population-based stepwise screening for unrecognised Type 2 diabetes is ineffective in general practice despite reliable algorithms. Diabetologia. 2004 Sep;47(9):1566-73. doi: 10.1007/s00125-004-1496-2. Epub 2004 Sep 8.
- BackgroundCardiology. ESo. Heartscore BMI score [Internet]. Available from: https://escol.escardio.org/heartscore/calc.aspx?model=europelow. 2014.
- BackgroundSocialstyrelsen. S. Sjukdomsförebyggande metoder. Vetenskabeligt underlag för nationella riktlinjer. 2011
- Derived from this study: PubMed 35562735Leick C, Larsen LB, Larrabee Sonderlund A, Svensson NH, Sondergaard J, Thilsing T. Non-participation in a targeted prevention program aimed at lifestyle-related diseases: a questionnaire-based assessment of patient-reported reasons. BMC Public Health. 2022 May 13;22(1):970. doi: 10.1186/s12889-022-13382-8.
- Derived from this study: PubMed 32770946Hansen CB, Pavlovic KMH, Sondergaard J, Thilsing T. Does GP empathy influence patient enablement and success in lifestyle change among high risk patients? BMC Fam Pract. 2020 Aug 8;21(1):159. doi: 10.1186/s12875-020-01232-8.
- Derived from this study: PubMed 32673269Thilsing T, Sonderlund AL, Sondergaard J, Svensson NH, Christensen JR, Thomsen JL, Hvidt NC, Larsen LB. Changes in Health-Risk Behavior, Body Mass Index, Mental Well-Being, and Risk Status Following Participation in a Stepwise Web-Based and Face-to-Face Intervention for Prevention of Lifestyle-Related Diseases: Nonrandomized Follow-Up Cohort Study. JMIR Public Health Surveill. 2020 Jul 9;6(3):e16083. doi: 10.2196/16083.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Jens Søndergaard principal investigator
Research Unit of General Practice, Dept. of Public Health, University of Southern Denmark, DK-5000 Odense C, Denmark
6 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lifestyle intervention in people with Type-2 Diabetes and Cardiovascular Diseases, run by University of Southern Denmark at 6 sites in 3 countries.
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 3 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: finished, as of the sponsor's last update on 29 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Denmark, Norway, 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in proportion of citizens at increased risk of lifestyle related disease from baseline to the 12 weeks follow up (time frame: At baseline and within 1 month following the 12 weeks study period.). 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 NCT02797392, which also lists 14 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 Apr 2019.