Validation of a Nutrition Screening Tool

Malnutrition Clinical Trial

Official title:

Mini Nutritional Assessment: Consumer Validation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01473706
• Other study ID #: 11.01.US.HCN
• Status: Completed
• Phase: N/A
• First received: November 10, 2011
• Last updated: July 16, 2013
• Start date: August 2011
• Est. completion date: June 2012

Study information

• Verified date: July 2013
• Source: Nestlé
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 463
• Est. completion date: June 2012
• Est. primary completion date: January 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 65 Years and older

Eligibility

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 Design

Time Perspective: Prospective

Related Conditions & MeSH terms

• Malnutrition

Intervention

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.

Locations

Country	Name	City	State
United States	Kantar Health	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Nestlé

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sensitivity and the specificity (in percent) of the consumer version of the Mini Nutritional Assessment versus a validated nutrition screening tool		Within a one hour visit	No
Secondary	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)		Within a one hour visit	No