A Prospective Cohort Study of Aged People for Chronic Diseases (HAPPY)

March 29, 2021 updated by: Soo Lim, Seoul National University Bundang Hospital

A Hospital-based Prospective Cohort Study With Aged People to Elucidate Predictive Factors Including Muscle and Fat Mass for Chronic Diseases and Mortality

This study is a hospital-based, prospective cohort study to elucidate the predictive factors including muscle and fat mass for chronic diseases and mortality in elderly persons aged 60 years and older.

Study Overview

Status

Completed

Conditions

Detailed Description

This study is a hospital-based, prospective cohort study to elucidate the predictive factors among anthropometric and biochemical parameters and body composition information for chronic diseases including diabetes mellitus, myocardial infarction, stroke, osteoporosis, fracture, and cognitive dysfunction, and mortality in elderly persons aged 60 years and older.

Study Type

Observational

Enrollment (Anticipated)

1000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
    • Gyeonggi
      • Seongnam, Gyeonggi, Korea, Republic of, 463-707
        • Seoul National University Bundang Hospital

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

60 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Aged 60 years and older Capable of communication with the research team Provided written informed consent

Description

Inclusion Criteria:

  • Aged 60 years and older
  • Capable of communication with the research team
  • Provided written informed consent

Exclusion Criteria:

  • Age < 60 years
  • active malignancy
  • uncompensated liver cirrhosis
  • ESRD
  • severe cognitive impairment which cannot communicate with the research term

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

Cohorts and Interventions

Group / Cohort
HAPPY Cohort
A elderly cohort for chronic diseases

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Alll cause mortality
Time Frame: 9 years
9 years

Secondary Outcome Measures

Outcome Measure
Time Frame
Cardiometabolic mortality
Time Frame: 9 years
9 years
Incidence of major adverse cardiac event including nonfatal myocardial infarction, nonfatal stroke, and unstable angina
Time Frame: 9 years
9 years
Incidence of frailty defined by the Korean Fraility Index
Time Frame: 9 years
9 years
Incidence of osteoporotic fracture
Time Frame: 9 years
9 years
Incidence of cognitive dysfunction measured by minimental status examination
Time Frame: 9 years
9 years
Development of sarcopenia defined by the Foundation for the National Institutes of Health (FNIH) criteria
Time Frame: 9 years
9 years

Collaborators and Investigators

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

Sponsor

Seoul National University Bundang Hospital

Investigators

  • Principal Investigator: Soo Lim, MD, PhD, SNUBH

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)

July 1, 2015

Primary Completion (Actual)

December 31, 2018

Study Completion (Actual)

March 15, 2021

Study Registration Dates

First Submitted

December 19, 2015

First Submitted That Met QC Criteria

December 22, 2015

First Posted (Estimate)

December 29, 2015

Study Record Updates

Last Update Posted (Actual)

March 30, 2021

Last Update Submitted That Met QC Criteria

March 29, 2021

Last Verified

March 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SNUBH-HAPPY Cohort

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

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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