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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 August 28, 2014