Validation of a Nutrition Screening Tool
This study is ongoing, but not recruiting participants.
Sponsor:
Nestlé
Information provided by (Responsible Party):
Nestlé
ClinicalTrials.gov Identifier:
NCT01473706
First received: November 10, 2011
Last updated: January 6, 2012
Last verified: January 2012
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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 ]
| Estimated Enrollment: | 418 |
| Study Start Date: | August 2011 |
| Estimated 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 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: | January 6, 2012 |
| 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 May 19, 2013