Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

This study has been completed.
Sponsor:
Collaborator:
Steno Diabetes Center
Information provided by (Responsible Party):
Birgitte Pickering, Glostrup University Hospital, Copenhagen
ClinicalTrials.gov Identifier:
NCT00289237
First received: September 19, 2005
Last updated: October 2, 2012
Last verified: October 2012
  Purpose

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 Intervention
CHD
AMI
CVD
Type 2 Diabetes
COLD
Behavioral: Lifestyle intervention

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: A Randomised Non-pharmacological Intervention Study for Prevention of Ischaemic Heart Disease Inter99

Resource links provided by NLM:


Further study details as provided by Glostrup University Hospital, Copenhagen:

Primary Outcome Measures:
  • Incidence of CHD and other lifestyle related diseases after ten years [ Time Frame: 2012 ] [ Designated as safety issue: No ]
    Ongoing analyses in National Central Registers (Oct 2012)


Secondary Outcome Measures:
  • Changes in lifestyle and biological markers after one, three and five years [ Time Frame: 2006 ] [ Designated as safety issue: No ]
    Analyses completed. Results at: www.Inter99.dk


Enrollment: 61301
Study Start Date: March 1999
Study Completion Date: March 2011
Primary Completion Date: March 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.


Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   30 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • All citizens in a predefined area

Exclusion Criteria:

  • Drug abuse
  • Language problem
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00289237

Locations
Denmark
Research Centre for Prevention and Health
Glostrup, Denmark, 2600
Sponsors and Collaborators
Glostrup University Hospital, Copenhagen
Steno Diabetes Center
Investigators
Principal Investigator: Torben Jørgensen, DrMedSci Research Centre for Prevention and Health
  More Information

Additional Information:
Publications:

Additional 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     History of Changes
Other Study ID Numbers: RCPH - 99-1
Study First Received: September 19, 2005
Last Updated: October 2, 2012
Health Authority: Denmark: National Board of Health

Keywords provided by Glostrup University Hospital, Copenhagen:
Lifestyle intervention
Behavioural changes
CHD
Type 2 diabetes

Additional relevant MeSH terms:
Coronary Artery Disease
Diabetes Mellitus, Type 2
Heart Diseases
Myocardial Ischemia
Arterial Occlusive Diseases
Arteriosclerosis
Cardiovascular Diseases
Coronary Disease
Diabetes Mellitus
Endocrine System Diseases
Glucose Metabolism Disorders
Metabolic Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on November 20, 2014