Lifestyle Intervention in a General Population for Prevention of Ischaemic Heart Disease
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ClinicalTrials.gov Identifier: NCT00289237 |
Recruitment Status :
Completed
First Posted : February 9, 2006
Last Update Posted : October 3, 2012
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In spite of declining trend coronary heart disease (CHD) is still a leading cause of morbidity and mortality. Many years of epidemiological research have identified several risk factors for CHD. The main causes are physical inactivity and inappropriate diet (mediated through high blood pressure, high cholesterol and fatness) and smoking. So far intervention studies on lifestyle factors have shown disappointing results, most probably due to insufficient interventions and methodology.
Inter99 is a randomized non-pharmacological intervention study comprising 61,301 persons representing a well-defined population. About 13,000 are invited for a health examination and assessment of risk for CHD. Those at high risk are offered lifestyle intervention in three waves over a five year period. A priori the group is divided into a high intensive and low intensive intervention group. The remaining 48.285 individuals serve as control.
After five years all individuals who attended the base-line examination are re-invited to assess the effect of the intervention on intermediate end-points as lifestyle, absolute risk of CHD and biological risk factors. The total cohort (61.301) is followed through central registers to evaluate the effect of the intervention on use of the health care system and the long term effect on incidence of CHD.
The status for the project is that the four waves of intervention have been performed, the last follow-up was in March 2006.
Data collection finalized with 10 years follow-up via Central National Registries and a questionnaire. No further follow-up is scheduled for the main purposes of the study.
Analyses as regard the primary effect (on incidence of cardiovascular diseases) and secondary effect (on incidence of type 2 diabetes) are on-going. Analyses for a large number of spin off project are on-going.
More than 25 Ph.d. studies and more than 200 peer-review publication have so far been produced.
Summary of results, links to articles and theses at: www.Inter99.dk
Condition or disease | Intervention/treatment | Phase |
---|---|---|
CHD AMI CVD Type 2 Diabetes COLD | Behavioral: Lifestyle intervention | Not Applicable |
In spite of declining trend coronary heart disease (CHD) is still a leading cause of morbidity and mortality. Many years of epidemiological research have identified several risk factors for CHD. The main causes are physical inactivity and inappropriate diet (mediated through high blood pressure, high cholesterol and fatness) and smoking. So far intervention studies on lifestyle factors have shown disappointing results.
Inter99 is a randomized non-pharmacological intervention study comprising 61,301 persons representing a well-defined population. About 13,000 are invited for a health examination and assessment of risk for CHD. Those at high risk are offered lifestyle intervention in three waves over a five year period. A priori the group is divided into a high intensive and low intensive intervention group. The remaining 48.285 individuals serve as control.
After five years all individuals who attended the base-line examination are re-invited to assess the effect of the intervention on intermediate end-points as lifestyle, absolute risk of CHD and biological risk factors. The total cohort (61.301) is followed through central registers to evaluate the effect of the intervention on use of the health care system and the long term effect on incidence of CHD.
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 61301 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Prevention |
Official Title: | A Randomised Non-pharmacological Intervention Study for Prevention of Ischaemic Heart Disease Inter99 |
Study Start Date : | March 1999 |
Actual Primary Completion Date : | March 2006 |
Actual Study Completion Date : | March 2011 |

Arm | Intervention/treatment |
---|---|
Experimental: High intensity intervention group
Lifestyle intervention consisted of 15-30 minutes of individual lifestyle counselling + offer of participation in group-based lifestyle counselling (½ year). This offer was given at baseline to all participants in the group. Persons at high risk of IHD: offer additionally given at 1- and 3-year follow-up |
Behavioral: Lifestyle intervention |
Experimental: Low intensity intervention group
Lifestyle intervention consisted of 15-30 minutes of individual lifestyle counselling. This offer was given at baseline to all participants in the group. Persons at high risk of IHD: offer additionally given at 1- and 3-year follow-up |
Behavioral: Lifestyle intervention |
No Intervention: Control group
Questionnaires regarding lifestyle and general health were sent to all participants in this group. The importance of healthy lifestyle was not mentioned, and no intervention was offered. |
- Incidence of CHD and other lifestyle related diseases after ten years [ Time Frame: 2012 ]Ongoing analyses in National Central Registers (Oct 2012)
- Changes in lifestyle and biological markers after one, three and five years [ Time Frame: 2006 ]Analyses completed. Results at: www.Inter99.dk

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Ages Eligible for Study: | 30 Years to 60 Years (Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- All citizens in a predefined area
Exclusion Criteria:
- Drug abuse
- Language problem

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00289237
Denmark | |
Research Centre for Prevention and Health | |
Glostrup, Denmark, 2600 |
Principal Investigator: | Torben Jørgensen, DrMedSci | Research Centre for Prevention and Health |
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | Birgitte Pickering, B. Pickering is the secretary of Professor Torben Joergensen, who is the primary investigator, Glostrup University Hospital, Copenhagen |
ClinicalTrials.gov Identifier: | NCT00289237 |
Other Study ID Numbers: |
RCPH - 99-1 |
First Posted: | February 9, 2006 Key Record Dates |
Last Update Posted: | October 3, 2012 |
Last Verified: | October 2012 |
Lifestyle intervention Behavioural changes CHD Type 2 diabetes |
Heart Diseases Myocardial Ischemia Coronary Artery Disease Diabetes Mellitus, Type 2 Diabetes Mellitus Glucose Metabolism Disorders Metabolic Diseases |
Endocrine System Diseases Cardiovascular Diseases Vascular Diseases Coronary Disease Arteriosclerosis Arterial Occlusive Diseases |