Study on Cardiovascular Health, Nutrition and Frailty in Older Adults in Spain (Seniors-ENRICA)

April 29, 2019 updated by: Fernando Rodríguez-Artalejo, Universidad Autonoma de Madrid
The purpose of this study is to examine the association between ideal cardiovascular health, diet and other lifestyles, biological risk factors, either well-established or emergent, and the risk of frailty in older adults, throughout different waves (2008-10, 2012 and 2015 -16).

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

1566

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

  • Spain
      • Madrid, Spain, 28029
        • Department of Preventive Medicine and Public Health, Universidad Autónoma de Madrid

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

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Community-living individuals in Spain aged 60 years or older.

Description

Inclusion Criteria:

  • Non-institutionalized Spanish resident
  • 60 years and over

Exclusion Criteria:

  • None

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from baseline in Frailty
Time Frame: 3 years
Method of assessment: Fried criteria
3 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from baseline in Cardiovascular health
Time Frame: 3 years
Method of assessment: 7 cardiovascular health metrics as defined by American Heart Association
3 years

Collaborators and Investigators

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

Sponsor

Universidad Autonoma de Madrid

Investigators

  • Principal Investigator: Jose R Banegas, MD, PhD, Department of Preventive Medicine and Public Health, Universidad Autónoma de Madrid
  • Principal Investigator: Fernando Rodríguez-Artalejo, MD, PhD, Department of Preventive Medicine and Public Health, Universidad Autónoma de Madrid

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 (Actual)

March 1, 2008

Primary Completion (Actual)

October 1, 2010

Study Completion (Actual)

June 1, 2017

Study Registration Dates

First Submitted

June 14, 2016

First Submitted That Met QC Criteria

June 16, 2016

First Posted (Estimate)

June 17, 2016

Study Record Updates

Last Update Posted (Actual)

May 1, 2019

Last Update Submitted That Met QC Criteria

April 29, 2019

Last Verified

April 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Seniors-ENRICA

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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