Type 2 Diabetes Clinical Trial
Official title:
A Randomised Non-pharmacological Intervention Study for Prevention of Ischaemic Heart Disease Inter99
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
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.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
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