NCT01473706

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
463

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Aug 2011

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2011

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

November 10, 2011

Completed
7 days until next milestone

First Posted

Study publicly available on registry

November 17, 2011

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2012

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2012

Completed
Last Updated

July 17, 2013

Status Verified

July 1, 2013

Enrollment Period

5 months

First QC Date

November 10, 2011

Last Update Submit

July 16, 2013

Conditions

Keywords

MalnutritionNutrition statusElderlyNutrition screening

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (1)

  • 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

Study Arms (2)

Consumers

Adults aged ≥ 65 years; Employed part-time, unemployed, retired, full-time or a homemaker; English speaking

Other: Consumer Mini Nutritional Assessment

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

Interventions

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 ConsumersConsumers

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersYes
Age GroupsOlder Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Consumers aged 65 or older with or without their caregiver

You may qualify if:

  • \- 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

You may not qualify if:

  • \- Consumer
  • \-- Full time employment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kantar Health

New York, New York, 10010, United States

Location

MeSH Terms

Conditions

Malnutrition

Condition Hierarchy (Ancestors)

Nutrition DisordersNutritional and Metabolic Diseases

Study Officials

  • Kerri Lehrhaupt

    Kantar Health

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 10, 2011

First Posted

November 17, 2011

Study Start

August 1, 2011

Primary Completion

January 1, 2012

Study Completion

June 1, 2012

Last Updated

July 17, 2013

Record last verified: 2013-07

Locations