Validation of a Nutrition Screening Tool

July 16, 2013 updated by: Nestlé

Mini Nutritional Assessment: Consumer Validation

The purpose of this study is to compare the accuracy of a new consumer nutrition screening tool to an established and validated nutrition screening tool currently completed by healthcare practitioners.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The main objective of the study is to determine the accuracy of the self-administered consumer Mini Nutritional Assessment by comparing the level of agreement in the categorization of nutritional status between the self-administered Mini Nutritional Assessment and a validated nutrition screening tool in a population aged 65 and older.

Study Type

Observational

Enrollment (Actual)

463

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

  • United States
    • New York
      • New York, New York, United States, 10010
        • Kantar Health

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

65 years and older (Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Consumers aged 65 or older with or without their caregiver

Description

Inclusion Criteria:

- Consumer

  • Age ≥ 65 years
  • Employed part-time, unemployed, retired, full-time homemaker

  • English speaking

    - Caregiver of Consumer

  • Family, relative, friend, professional caregiver of an individual age ≥ 65 years

  • Lives with individual aged ≥ 65 years OR Visits individual aged ≥ 65 years five or more days a week

    • Makes decisions or has strong influence on the individual aged ≥ 65 years' diet and medical needs.
  • English speaking

Exclusion Criteria:

- Consumer

-- Full time employment

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

  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Consumers
Adults aged ≥ 65 years; Employed part-time, unemployed, retired, full-time or a homemaker; English speaking
Other: Consumer Mini Nutritional Assessment
A 11 question, self administered nutrition screening tool. The consumer and their caregiver will complete the consumer version of the Mini Nutritional Assessment. A healthcare professional will then meet with the consumer and complete a nutrition screening with utilizing a validated nutrition screening tool.
Caregivers of Consumers
Family, relative, friend, professional caregiver of an individual age ≥ 65 years; Lives with individual aged ≥ 65 years OR Visits individual aged ≥ 65 years five or more days a week; Makes decisions or has strong influence on the individual aged ≥ 65 years' diet and medical needs; English speaking
Other: Consumer Mini Nutritional Assessment
A 11 question, self administered nutrition screening tool. The consumer and their caregiver will complete the consumer version of the Mini Nutritional Assessment. A healthcare professional will then meet with the consumer and complete a nutrition screening with utilizing a validated nutrition screening tool.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Sensitivity and the specificity (in percent) of the consumer version of the Mini Nutritional Assessment versus a validated nutrition screening tool
Time Frame: Within a one hour visit
Within a one hour visit

Secondary Outcome Measures

Outcome Measure
Time Frame
Ability of the consumer version of the Mini Nutritional Assessment to predict the accuracy of the nutrition status classifications (normal nutritional status, at risk of malnutrition & malnourished)
Time Frame: Within a one hour visit
Within a one hour visit

Collaborators and Investigators

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

Sponsor

Nestlé

Investigators

  • Principal Investigator: Kerri Lehrhaupt, Kantar Health

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

August 1, 2011

Primary Completion (Actual)

January 1, 2012

Study Completion (Actual)

June 1, 2012

Study Registration Dates

First Submitted

November 10, 2011

First Submitted That Met QC Criteria

November 14, 2011

First Posted (Estimate)

November 17, 2011

Study Record Updates

Last Update Posted (Estimate)

July 17, 2013

Last Update Submitted That Met QC Criteria

July 16, 2013

Last Verified

July 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 11.01.US.HCN

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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