Please select the eligibility criteria that correspond to the clinical trial below.
Title: 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


Options:
A: Inclusion Criteria:

* All citizens in a predefined area

Exclusion Criteria:

* Drug abuse
* Language problem
B: Inclusion Criteria:

* Participants were required to be sedentary, between 18-65 years old, have a BMI above 25.0 kg/m2 and physical inactive (not meeting the MVPA recommendations and not exceed 6000 steps/day). In addition subjects had to be free of any major disease with a general healthy status warranted.

Exclusion Criteria:

* Taking any medication or dietary supplements that may interfere with body composition or energy expenditure regulation, performing more than 5000 steps/day and meeting actual MVPA recommendations
C: Inclusion Criteria:

* Office workers with mainly sedentary tasks
* BMI 25-40

Exclusion Criteria:

* Severe depression and/or anxiety
* Exhaustion disorder
* Diabetes Mellitus
* Severe cardiovascular disease
* Severe kidney disease
* Musculoskeletal disorders that prohibit walking on a treadmill
* Contraindications for physical activity
* Thyroidea illness
* Pregnancy

For fMRI-study, additional exclusion criteria are:

* Implanted metal- or electrical devices
* Pregnancy
* Extraneous metal pieces in the body
D: Inclusion Criteria:

1. Workplaces should be:

   * Office-based with sedentary workers
   * Able to include four sections of about equal size (about 25 people) and which could be separated to minimize spill-over effects (e.g. four different addresses, buildings or floors).
   * Have a management willing to collaborate about the project by participating at meetings and at kick-off.
   * Should have at least some financial resources to make structural changes at the work place.
2. Individuals should be:

   * Adults \>18 years
   * Sedentary office-based work-
   * Understanding of Danish
   * Without sickness or disabilities affecting their ability to stand or walk
   * Not pregnant
   * Working more than 4 days a week (\>30 h)

Exclusion Criteria:

* Not providing signed informed consent.

Answer: A