Lifestyle Intervention in a General Population for Prevention of Ischaemic Heart Disease

NCT00289237 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 61301

Last updated 2012-10-03

No results posted yet for this study

Summary

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

Conditions

Interventions

BEHAVIORAL

Lifestyle intervention

Sponsors & Collaborators

  • Steno Diabetes Center Copenhagen

    collaborator OTHER
  • Glostrup University Hospital, Copenhagen

    lead OTHER

Principal Investigators

  • Torben Jørgensen, DrMedSci · Research Centre for Prevention and Health

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
30 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
1999-03-31
Primary Completion
2006-03-31
Completion
2011-03-31

Countries

  • Denmark

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00289237 on ClinicalTrials.gov