The Ebeltoft Health Promotion Project
Condition: Primary Prevention
Study type: Interventional
Phase: Phase 3

Summary: 
      The objective of The Ebeltoft Health Promotion Project is investigate the effect of
      multiphasic preventive health screenings and discussions with general practitioners of a
      random population of patients in primary care.

      Outcome parameters are the cardiovascular risk profile, number of health care contacts, life
      years gained, direct costs, i.e. health care costs, and total cost, i.e. including
      productivity costs.
    

Detailed description: 
      The Ebeltoft project was designed as a randomized controlled trial in the district of
      Ebeltoft, Aarhus County, Denmark. All nine general practitioners (GPs) from the four primary
      care units in the district participated. All patients listed in the primary care units
      between 30 and 49 years of age by January 1, 1991 (N=3,464) were identified in the Danish
      Civil Registration system, each Danish resident has a ten digit number, through which
      personal data can be extracted from the health and social registries. A random selection of
      2,030 of the 3,464 persons was sampled for invitation to participate in the study. Those who
      agreed to participate were randomly divided into one control group and two intervention
      groups (A and B). Randomization of subjects into control and intervention groups was
      stratified by primary care unit, sex, age, body mass index (BMI), and cohabitation status as
      stated by the subjects in the invitation questionnaire. Invited subjects received an
      invitation questionnaire in September 1991. All subjects who agreed to participate also
      received questionnaires about their health, health beliefs, and social and demographic status
      at baseline and after one and five years. Subjects in the two intervention groups were
      offered a broad (multiphasic) health screening at baseline and after one and five years.
      After five years all subjects received a questionnaire and an invitation to a health
      screening and consultation. From December 1, 1991 to October 1, 1997 specially trained
      laboratory technicians carried out health screenings that included evaluations of
      cardiovascular, pulmonary, liver and kidney function, endocrine dysfunction, BMI, physical
      endurance, hearing and sight. Evaluation of cardiovascular function included a calculation of
      cardiovascular risk score (CRS), giving an estimate of the risk of premature cardiovascular
      disease for each individual. CRS was based on sex, familial inheritance (number of family
      members with ischemic heart disease before age 55), tobacco consumption, blood pressure,
      total serum cholesterol, and BMI.1 Within three weeks of the screenings, all participants
      received a written letter from their GP explaining the tests. Targeted life style counsels
      were included in the letter if the test results were outside a predefined range. All subjects
      who had been informed that they had an elevated or high CRS were encouraged to see their GP,
      regardless of their intervention status. After the health screenings, the subjects in group B
      were invited to attend a 45-minute patient centred health consultation with their GP. The
      health consultations were aimed primarily at discussing lifestyle-related health problems and
      giving the subject an opportunity to define up to three goals relating to lifestyle changes.

      We investigate the impact of the intervention on the cardiovascular risk profile, number of
      health care contacts, the direct and total costs, and the health effects by comparing mean
      costs and expected life years gained of the intervention groups with those of the control
      group.
    

Intervention name(s): Life style
Intervention type(s): Behavioral
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: multiphasic screening; primary health care; randomized controlled trial; Risk factors