Long-term Follow-up of the Helsinki Businessmen Study

Study Overview
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Brief Summary
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The Helsinki Businessmen Study (HBS) is a clinico-epidemiological longitudinal study started in 1964. It also included a 5-year randomized, controlled multifactorial primary prevention trial of cardiovascular diseases between 1974-1980. The cohort is being actively followed-up through national registers since the 1980, and since 2000 with regular questionnaire surveys. Latest in 2015. Also clinical and laboratory studies have been performed in random subcohorts. Follow-up is ongoing with new hypothesis-generating research questions.

Detailed Description
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The Helsinki Businessmen Study (HBS) was originally a convenient cohort of male executives and businessmen (born 1919-1934, n=3490), who participated in health check-ups between 1964-1973, but since the beginning of 1970s it has developed into a clinico-epidemiological longitudinal study. Primary focus was on the prevention of cardiovascular diseases (CVD), but since 2000 focus has been shifting to geriatrics, and with its long follow-up (up to 50 years) HBS can be seen as a life-course study. Traditional CVD risk factors are available from the 1960s and in 1974 participants (available n=3310) were divided in groups according to their clinical status and CVD risk. Two high-risk groups (n=1222) and low-risk group (n=593) participated in a 5-year multifactorial primary prevention study in 1974-1980 (in-trial and post-trial results have been published in 1985 and 1991). The whole original cohort has been followed-up from national registers since 1985 and with regular questionnaire surveys since 2000. Random subcohorts have been studied clinically with laboratory and genetic examinations in 2003 and 2011. The latest questionnaire survey was performed in winter 2015 by which two thirds of the original cohort had died. Follow-up of the cohort is ongoing and new research questions formulated..

Official Title
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Long-term Follow-up of the Helsinki Businessmen Study Cohort of Men Born in 1919-1934

Conditions
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Quality of Life, Syndromes, Aging, Cardiovascular Disease, Death

Intervention / Treatment
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* Other: Intervention


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Participants of director studies at the Institute of Occupational Health in Helsinki, Finland, between 1964-1973 Exclusion Criteria: Non-participants

Ages Eligible for Study
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Minimum Age: 31 Years
Maximum Age: 46 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Total, observational<br>Various cardiovascular risk groups described below | |
| High-risk intervention<br>Healthy but at high risk in 1974 | Other: Intervention<br>* Multifactorial intervention with lifestyle changes and drugs as needed<br>|
| High-risk control<br>Healthy but at high risk in 1974 | |
| Low-risk conrtol<br>Healthy and at low risk in 1974 | |
| Sick control<br>Medications or clinical disease in 1974 | |
| Refused<br>Refused or no response in 1974 | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total mortality: national registers |  | change from baseline up to 612 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Health-related quality of life: questionnaire data |  | change from baseline up to 612 months | 
| Geriatric syndromes and disability: questionnaires, clinical examinations, registers |  | change from baseline up to 612 months | 
| Morbidity: self-report, national registers, hospital and autopsy records |  | change from baseline up to 612 months | 
| Medications: self-report, national registers |  | change from baseline up to 612 months | 
| Cause-specific mortality: national registers, autopsy records |  | change from baseline up to 612 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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cardiovascular disease, frailty, quality of life, mortality, prevention