Kuopio Ischaemic Heart Disease Risk Factor Study (Nutrition Component)

April 17, 2019 updated by: University of Eastern Finland
To determine associations between dietary factors and risk of major chronic diseases and their risk factors

Study Overview

Status

Active, not recruiting

Conditions

Detailed Description

STUDY POPULATION The Kuopio Ischaemic Heart Disease Risk Factor Study (KIHD) is an on-going prospective, population-based cohort study of risk factors for cardiovascular diseases, other chronic diseases and metabolic conditions in a sample of men from eastern Finland. The baseline examinations were carried out between 1984 and 1989, when 2,682 men (82.9% of those eligible) who were 42, 48, 54 or 60 years old were recruited. The first cohort consisted of 1166 men who were 54 years old, enrolled in 1984-1986, and the second cohort included 1516 men who were 42, 48, 54 or 60 years old, enrolled in 1986-1989. The baseline examinations were followed by the 4-year examinations (1991-1993), in which 1038 men from the second cohort (88% of the eligible) participated. At the 11-year examinations (1998-2001), all men from the second cohort were invited and 854 men (95% of the eligible) participated. These examinations were also the baseline for 920 postmenopausal women (78.4% of the 1173 eligible women) from the same area, aged 53-73 years. During the 20-year examination round, all men from the first and second baseline cohorts and all women were invited to the study site, and a total of 1241 men (80% of the eligible) and 634 women (81.0%) participated.

ASSESSMENT OF DIETARY INTAKES Food consumption has been assessed with an instructed food recording of four days, one of which was a weekend day, by household measures. A picture book of common foods and dishes was used to help in estimation of portion sizes. For each food item the participant could choose from 3-5 commonly used portion sizes or describe the portion size in relation to those in the book. In order to further improve accuracy, instructions were given and completed food records were checked by a nutritionist together with a participant. Nutrient intakes were estimated using the NUTRICA® 2.5 software (Social Insurance Institution, Turku, Finland). The databank of the software is mainly based on Finnish values of nutrient composition of foods.

OUTCOME ASSESSMENT Registration of the incidence of major chronic diseases and deaths during the follow up is based on the national registries (Hospital discharge registry, Cause of death register, Social Insurance Institution of Finland register for reimbursement of medicine expenses) by use of the Finnish personal identification code (social security number), and/or on findings at the re-examination rounds (such as fasting plasma glucose or 2-h oral glucose tolerance test to define type 2 diabetes in addition to data from the national registries).

Study Type

Observational

Enrollment (Actual)

2682

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

42 years to 73 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

See "Detailed description"

Description

Inclusion Criteria:

  • Aged 42, 48, 54 or 60 years (men at baseline in 1984-1989)
  • Aged 53 to 73 years (women at their baseline in 1998-2001)
  • Living in the city of Kuopio or neighboring rural areas

Exclusion Criteria:

  • Condition that prevented visit at study clinic

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cardiovascular disease
Time Frame: Annually between March 1984 and December 2052
Incidence of cardiovascular disease
Annually between March 1984 and December 2052
Carotid atherosclerosis
Time Frame: From baseline to 4-y, 11-y and 20-y examinations
Progression of common carotid artery - intima-media thickness (CCA-IMT)
From baseline to 4-y, 11-y and 20-y examinations
Death
Time Frame: Annually between March 1984 and December 2052
Incidence of death
Annually between March 1984 and December 2052

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Type 2 diabetes
Time Frame: Annually between March 1984 and December 2052
Incidence of type 2 diabetes
Annually between March 1984 and December 2052
Dementia
Time Frame: Annually between March 1984 and December 2052
Incidence of dementia
Annually between March 1984 and December 2052
Cancer
Time Frame: Annually between March 1984 and December 2052
Incidence of cancer
Annually between March 1984 and December 2052
Infectious disease
Time Frame: Annually between March 1984 and December 2052
Incidence of hospitalization due infectious disease
Annually between March 1984 and December 2052

Collaborators and Investigators

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

Sponsor

University of Eastern Finland

Investigators

  • Principal Investigator: Jussi Kauhanen, MD, PhD, University of Eastern Finland, Institute of Public Health and Clinical Nutrition

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

Helpful Links

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 (Actual)

March 1, 1984

Primary Completion (Anticipated)

December 31, 2052

Study Completion (Anticipated)

December 31, 2052

Study Registration Dates

First Submitted

July 7, 2017

First Submitted That Met QC Criteria

July 13, 2017

First Posted (Actual)

July 18, 2017

Study Record Updates

Last Update Posted (Actual)

April 18, 2019

Last Update Submitted That Met QC Criteria

April 17, 2019

Last Verified

April 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KIHD Nutrition

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Plan Description

Data available for collaborative projects

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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