Long-term Follow-up of the Helsinki Businessmen Study (HBS)

August 14, 2015 updated by: Timo Strandberg, Helsinki University Central Hospital

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

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

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..

Study Type

Observational

Enrollment (Actual)

3490

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

31 years to 46 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Sampling Method

Non-Probability Sample

Study Population

Originally a convenient cohort of male executives and businessmen (born 1919-1934, n=3490), who participated in health check-ups during 1964-1973, but since the beginning of 1970s it has developed into a clinic-epidemiological longitudinal study.

Description

Inclusion Criteria:

  • Participants of director studies at the Institute of Occupational Health in Helsinki, Finland, between 1964-1973

Exclusion Criteria:

  • Non-participants

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Helsinki University Central Hospital

Investigators

  • Principal Investigator: Timo E Strandberg, MD, Helsinki University Central Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 1964

Primary Completion (Anticipated)

December 1, 2040

Study Completion (Anticipated)

December 1, 2040

Study Registration Dates

First Submitted

June 10, 2015

First Submitted That Met QC Criteria

August 14, 2015

First Posted (Estimate)

August 18, 2015

Study Record Updates

Last Update Posted (Estimate)

August 18, 2015

Last Update Submitted That Met QC Criteria

August 14, 2015

Last Verified

August 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HBS Group

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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