NCT02804672

Brief Summary

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,566

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2008

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2008

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2010

Completed
5.7 years until next milestone

First Submitted

Initial submission to the registry

June 14, 2016

Completed
3 days until next milestone

First Posted

Study publicly available on registry

June 17, 2016

Completed
12 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2017

Completed
Last Updated

May 1, 2019

Status Verified

April 1, 2019

Enrollment Period

2.6 years

First QC Date

June 14, 2016

Last Update Submit

April 29, 2019

Conditions

Keywords

Cardiovascular healthDietFunctional limitationsFrailtyOlder adults

Outcome Measures

Primary Outcomes (1)

  • Change from baseline in Frailty

    Method of assessment: Fried criteria

    3 years

Secondary Outcomes (1)

  • Change from baseline in Cardiovascular health

    3 years

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • Non-institutionalized Spanish resident
  • years and over

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Madrid, 28029, Spain

Location

Related Publications (11)

  • Banegas JR, de la Cruz JJ, Graciani A, Lopez-Garcia E, Gijon-Conde T, Ruilope LM, Rodriguez-Artalejo F. Impact of Ambulatory Blood Pressure Monitoring on Reclassification of Hypertension Prevalence and Control in Older People in Spain. J Clin Hypertens (Greenwich). 2015 Jun;17(6):453-61. doi: 10.1111/jch.12525. Epub 2015 Mar 16.

  • Garcia-Esquinas E, Graciani A, Guallar-Castillon P, Lopez-Garcia E, Rodriguez-Manas L, Rodriguez-Artalejo F. Diabetes and risk of frailty and its potential mechanisms: a prospective cohort study of older adults. J Am Med Dir Assoc. 2015 Sep 1;16(9):748-54. doi: 10.1016/j.jamda.2015.04.008. Epub 2015 May 16.

  • Lana A, Rodriguez-Artalejo F, Lopez-Garcia E. Dairy Consumption and Risk of Frailty in Older Adults: A Prospective Cohort Study. J Am Geriatr Soc. 2015 Sep;63(9):1852-60. doi: 10.1111/jgs.13626. Epub 2015 Aug 27.

  • Sandoval-Insausti H, Perez-Tasigchana RF, Lopez-Garcia E, Garcia-Esquinas E, Rodriguez-Artalejo F, Guallar-Castillon P. Macronutrients Intake and Incident Frailty in Older Adults: A Prospective Cohort Study. J Gerontol A Biol Sci Med Sci. 2016 Oct;71(10):1329-34. doi: 10.1093/gerona/glw033. Epub 2016 Mar 4.

  • Graciani A, Garcia-Esquinas E, Lopez-Garcia E, Banegas JR, Rodriguez-Artalejo F. Ideal Cardiovascular Health and Risk of Frailty in Older Adults. Circ Cardiovasc Qual Outcomes. 2016 May;9(3):239-45. doi: 10.1161/CIRCOUTCOMES.115.002294. Epub 2016 May 10.

  • Vazquez-Fernandez A, Caballero FF, Yevenes-Briones H, Struijk EA, Baylin A, Fung TT, Lopez-Garcia E. Plant and Animal Protein Intake and Transitions From Multimorbidity to Frailty and Mortality in Older Adults. J Cachexia Sarcopenia Muscle. 2025 Feb;16(1):e13729. doi: 10.1002/jcsm.13729.

  • Marcos-Delgado A, Yevenes-Briones H, Fernandez-Villa T, Martin-Sanchez V, Guallar-Castillon P, Rodriguez-Artalejo F, Lopez-Garcia E. Association between diet quality and malnutrition: pooled results from two population-based studies in older adults. BMC Geriatr. 2024 May 10;24(1):417. doi: 10.1186/s12877-024-04984-5.

  • Delgado-Velandia M, Maroto-Rodriguez J, Ortola R, Garcia-Esquinas E, Rodriguez-Artalejo F, Sotos-Prieto M. Plant-Based Diets and All-cause and Cardiovascular Mortality in a Nationwide Cohort in Spain: The ENRICA Study. Mayo Clin Proc. 2022 Nov;97(11):2005-2015. doi: 10.1016/j.mayocp.2022.06.008.

  • Sotos-Prieto M, Ortola R, Lopez-Garcia E, Rodriguez-Artalejo F, Garcia-Esquinas E. Adherence to the Mediterranean Diet and Physical Resilience in Older Adults: The Seniors-ENRICA Cohort. J Gerontol A Biol Sci Med Sci. 2021 Feb 25;76(3):505-512. doi: 10.1093/gerona/glaa277.

  • Garcia-Esquinas E, Rodriguez-Sanchez I, Ortola R, Lopez-Garcia E, Caballero FF, Rodriguez-Manas L, Banegas JR, Rodriguez-Artalejo F. Gender Differences in Pain Risk in Old Age: Magnitude and Contributors. Mayo Clin Proc. 2019 Sep;94(9):1707-1717. doi: 10.1016/j.mayocp.2019.03.034.

  • Sandoval-Insausti H, Blanco-Rojo R, Graciani A, Lopez-Garcia E, Moreno-Franco B, Laclaustra M, Donat-Vargas C, Ordovas JM, Rodriguez-Artalejo F, Guallar-Castillon P. Ultra-processed Food Consumption and Incident Frailty: A Prospective Cohort Study of Older Adults. J Gerontol A Biol Sci Med Sci. 2020 May 22;75(6):1126-1133. doi: 10.1093/gerona/glz140.

MeSH Terms

Conditions

Frailty

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Fernando Rodríguez-Artalejo, MD, PhD

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

    PRINCIPAL INVESTIGATOR
  • Jose R Banegas, MD, PhD

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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Preventive Medicine and Public Health

Study Record Dates

First Submitted

June 14, 2016

First Posted

June 17, 2016

Study Start

March 1, 2008

Primary Completion

October 1, 2010

Study Completion

June 1, 2017

Last Updated

May 1, 2019

Record last verified: 2019-04

Locations