Validation of a Nutrition Screening Tool

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Nestlé
ClinicalTrials.gov Identifier:
NCT01473706
First received: November 10, 2011
Last updated: July 16, 2013
Last verified: July 2013
  Purpose

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.


Condition Intervention
Malnutrition
Other: Consumer Mini Nutritional Assessment

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Mini Nutritional Assessment: Consumer Validation

Resource links provided by NLM:


Further study details as provided by Nestlé:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Enrollment: 463
Study Start Date: August 2011
Study Completion Date: June 2012
Primary Completion Date: January 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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.

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.

  Eligibility

Ages Eligible for Study:   65 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Consumers aged 65 or older with or without their caregiver

Criteria

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

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01473706

Locations
United States, New York
Kantar Health
New York, New York, United States, 10010
Sponsors and Collaborators
Nestlé
Investigators
Principal Investigator: Kerri Lehrhaupt Kantar Health
  More Information

No publications provided

Responsible Party: Nestlé
ClinicalTrials.gov Identifier: NCT01473706     History of Changes
Other Study ID Numbers: 11.01.US.HCN
Study First Received: November 10, 2011
Last Updated: July 16, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Nestlé:
Malnutrition
Nutrition status
Elderly
Nutrition screening

Additional relevant MeSH terms:
Malnutrition
Nutrition Disorders

ClinicalTrials.gov processed this record on April 17, 2014