Feasibility of Estimating the Prevalence of Malnutrition, Frailty and Sarcopenia in Older People in UK Biobank, Cross-sectional Study: A Study Protocol

April 27, 2021 updated by: Nada Adnan AlMohaisen, University of Manchester

Background: measuring the prevalence of malnutrition, frailty and sarcopenia in same group of older adults is effective in understanding the relation between these conditions. This could support diagnosing, treatment and prevention in future practice. The research is aiming to measure the estimate prevalence of malnutrition, frailty, sarcopenia and their overlap in older adults, using the UK Biobank. In addition, it will aim to compare the two models of frailty the phenotype and deficit accumulation using the UK Biobank database, as data comparing these models is limited.

Methods/design: This is a cross-sectional study design that will use the UK Biobank database, which includes 381,000 participants males and females, aged 50 years and above, who completed the UK Biobank baseline assessments were included that is a subset from the main sample size from the UK Biobank. For baseline, details of participant's characteristics will be included. All three conditions will be identified as malnutrition by using GLIM criteria, while frailty by using two models; the first model will be the 36 deficits model and phenotype model. Finally, sarcopenia condition will be judge according to EWGSOP standard. All these models will be determining the feasibility to apply it using the available database in the UK Biobank.

Discussion: This proposed study will help in understanding the relation between malnutrition, frailty and sarcopenia. As in worldwide, there is little published research on the overlap between malnutrition, frailty and sarcopenia. Despite definitions and diagnostic criteria were developed for these conditions. There is conflict extend to the definitions and identification criteria's. This study will use UK Biobank database to measuring the estimate prevalence in older people and determine the overlap between three conditions.

Study Overview

Status

Completed

Detailed Description

The UK Biobank is a population-based study of a large prospective longitudinal cohort with information on 500,000 people, who were aged 40-69 when recruited in 2006-2010 from England, Scotland and Wales. The database includes demographic data, online questionnaires, X-rays and scan image of (brain, heart, abdomen, bones and carotid artery), as well as urine and saliva samples and blood biochemistry including: hormones and blood lipid. The online questionnaires (about: diet, cognitive function, work history and digestive health). It aims to improve the following: prevention, diagnosis and treatment for a broad number of diseases including cancer, heart diseases, stroke, diabetes, arthritis, osteoporosis, eye disorders, depression and forms of dementia. This detailed information on participants provide a resource for investigators to conduct research related a particular diseases.

There are four phases of assessment in UK Biobank. The first phase was the UK Biobank Pilot assessment that included 3798 participants from Stockport only in 2006. Then, the second phase was the initial assessment visit that started in 2007 until 2010. This was the baseline assessment and included approximately 500000 participants. After that, the third phase was conducted and called the first repeat assessment visit which took place between 2012-2013 and included 20346 participants. Lastly, the imaging visit which is considered the fourth phase started in 2014 until present.

Study Type

Observational

Enrollment (Actual)

381000

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

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

50 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Virtually all members of the general population are registered with a general practitioner through the NHS. Subsequently, recruitment was through NHS and all people aged 40-69 were eligible to participate. An invitation by mail was sent to those people who were living within reasonable travelling distance from assessment centres of UK Biobank. Additional information was collected prior sending an invitation; title, forename, gender, address, date of birth, name and address of General Practitioner and NHS number.

Description

Inclusion Criteria:

The inclusion criteria will be both genders, age more than or equal to 50 years old, who completed the touchscreen questionnaire, 24-hour recall and physical measurements to enable the identification of malnutrition, frailty and sarcopenia.

Exclusion Criteria:

Any participant who is under 50 or with incomplete information will be excluded.

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
Determine the feasibility of obtaining variables to be able to determine malnutrition, frailty and sarcopenia in the UK Biobank.
Time Frame: cross sectional, 2007
Determine if the variables in the UK biobank would be able to use different models to investigating malnutrition by mapping GLIM criteria, frailty by mapping it with two models 36 deficits and phenotype model. while sarcopenia will be matched with EWGSOP standard.
cross sectional, 2007
Measuring the prevalence of the three conditions by applying the models in UK Biobank.
Time Frame: cross sectional, 2007
Measuring the estimate prevalence of malnutrition, frailty and sarcopenia in older people using UK Biobank database.
cross sectional, 2007

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Determine the overlap between three conditions in the baseline assessment
Time Frame: cross sectional, 2007
Frailty overlaps with sarcopenia and malnutrition due to similarities of outcome related to body weight. In addition, frailty and sarcopenia have recently had set definitions and diagnostic criteria
cross sectional, 2007
Compare prevalence results between different models
Time Frame: cross sectional, 2007
Estimating the frailty prevalence using two different measurement techniques the phenotype model with cumulative deficits model. In order to draw conclusion by comparing the results from each model.
cross sectional, 2007

Collaborators and Investigators

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

Investigators

  • Study Director: Sorrel Burden, University Of Manchester

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.

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)

April 1, 2007

Primary Completion (ACTUAL)

November 20, 2020

Study Completion (ACTUAL)

November 20, 2020

Study Registration Dates

First Submitted

November 30, 2020

First Submitted That Met QC Criteria

November 30, 2020

First Posted (ACTUAL)

December 7, 2020

Study Record Updates

Last Update Posted (ACTUAL)

April 30, 2021

Last Update Submitted That Met QC Criteria

April 27, 2021

Last Verified

April 1, 2021

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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