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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
Sponsor:
Collaborator:
Steno Diabetes Center
Information provided by (Responsible Party):
Birgitte Pickering, Glostrup University Hospital, Copenhagen

Tracking Information
First Submitted Date  ICMJE September 19, 2005
First Posted Date  ICMJE February 9, 2006
Last Update Posted Date October 3, 2012
Study Start Date  ICMJE March 1999
Actual Primary Completion Date March 2006   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 2, 2012)
Incidence of CHD and other lifestyle related diseases after ten years [ Time Frame: 2012 ]
Ongoing analyses in National Central Registers (Oct 2012)
Original Primary Outcome Measures  ICMJE
 (submitted: February 8, 2006)
Incidence of CHD and other lifestyle related diseases after ten years
Change History Complete list of historical versions of study NCT00289237 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: October 2, 2012)
Changes in lifestyle and biological markers after one, three and five years [ Time Frame: 2006 ]
Analyses completed. Results at: www.Inter99.dk
Original Secondary Outcome Measures  ICMJE
 (submitted: February 8, 2006)
Changes in lifestyle and biological markers after one, three and five years
Current Other Outcome Measures  ICMJE Not Provided
Original Other Outcome Measures  ICMJE Not Provided
 
Descriptive Information
Brief Title  ICMJE Lifestyle Intervention in a General Population for Prevention of Ischaemic Heart Disease
Official Title  ICMJE A Randomised Non-pharmacological Intervention Study for Prevention of Ischaemic Heart Disease Inter99
Brief 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

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.

Study Type  ICMJE Interventional
Study Phase Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE
  • CHD
  • AMI
  • CVD
  • Type 2 Diabetes
  • COLD
Intervention  ICMJE Behavioral: Lifestyle intervention
Study Arms
  • 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

    Intervention: 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

    Intervention: 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.

Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 2, 2012)
61301
Original Enrollment  ICMJE
 (submitted: February 8, 2006)
61201
Actual Study Completion Date March 2011
Actual Primary Completion Date March 2006   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • All citizens in a predefined area

Exclusion Criteria:

  • Drug abuse
  • Language problem
Sex/Gender
Sexes Eligible for Study: All
Ages 30 Years to 60 Years   (Adult)
Accepts Healthy Volunteers Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Denmark
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00289237
Other Study ID Numbers  ICMJE RCPH - 99-1
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Birgitte Pickering, Glostrup University Hospital, Copenhagen
Study Sponsor  ICMJE Glostrup University Hospital, Copenhagen
Collaborators  ICMJE Steno Diabetes Center
Investigators  ICMJE
Principal Investigator: Torben Jørgensen, DrMedSci Research Centre for Prevention and Health
PRS Account Glostrup University Hospital, Copenhagen
Verification Date October 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP