Malnutrition in People With Complex Multiple Disabilities

February 16, 2011 updated by: Maastricht University Medical Center

Understanding of Malnutrition in People With Complex Multiple Disabilities

Underweight is more prevalent in people with a mental handicap than in people without a mental handicap, especially in people with a severe mental handicap. It is unknown if these people are malnourished. There is no validated screening instrument available to determine the nutrition status in people with complex multiple disabilities. Research regarding malnutrition based on body composition and nutrients in stead of anthropometric data is important.

The aim of the study is to understand the nutritional status of people with complex multiple disabilitiest through measurement of body composition and nutritients. The primary objective of the study is: What percentage of people with complex multiple disabilities are malnourished, based on altered body composition and nutritients? Understanding the nutritional status of these patients is important in order for them to receive appropriate and effective treatment. This treatment is of interest for general health and the quality of daily life.

Study Overview

Status

Unknown

Conditions

Study Type

Observational

Enrollment (Anticipated)

125

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

  • Netherlands
    • Limburg
      • Maastricht, Limburg, Netherlands, 6202 AZ
        • Recruiting
        • Maastricht University Medical Center
        • Contact:
        • Principal Investigator:
          • Nicky SJ Halbach, MD

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

125 people with complex multiple disabilities, living in a care institution participating in the Governor Kremers Centre (GKC).

Description

Inclusion Criteria:

  • Person with complex multiple disabilities;
  • Living in a care institution participating in the Governor Kremers Centre (GKC);
  • Chronically confined to a wheelchair or bedridden;
  • 18+ years

Exclusion Criteria:

  • Parenteral nutrition;
  • Serious infection;
  • Terminal illness

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
Complex multiple disabilities
People with complex multiple disabilities, living in a care institution participating in the Governor Kremers Centre (GKC.)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
What percentage of people with complex multiple disabilities are malnourished, based on altered body composition and nutritients?
Time Frame: One hour
Concerning measurement of body composition, the Deuterium dilution method will be used. A blood sample will be collected for measurement of nutrients. Furthermore, clinical parameters (weight, height and abdominal girth) will be measured.
One hour

Collaborators and Investigators

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

Sponsor

Maastricht University Medical Center

Collaborators

Stichting Pergamijn (Gouverneur Kremers Centrum/azM)
Koraalgroep(Gouverneur Kremers Centrum/azM)
Lunetzorg (Gouverneur Kremers Centrum/azM)

Investigators

  • Study Director: Leopold MG Curfs, Professor, Maastricht University Medical Center
  • Study Director: Eric EJ Smeets, MD, Maastricht University Medical Center

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

February 1, 2011

Primary Completion (Anticipated)

September 1, 2013

Study Completion (Anticipated)

September 1, 2013

Study Registration Dates

First Submitted

November 10, 2010

First Submitted That Met QC Criteria

November 10, 2010

First Posted (Estimate)

November 11, 2010

Study Record Updates

Last Update Posted (Estimate)

February 17, 2011

Last Update Submitted That Met QC Criteria

February 16, 2011

Last Verified

February 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NL32655.068.10
  • MEC 10-2-043 (Other Identifier: Medical Ethical Committee University Hospital Maastricht)

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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