MalnutritionNCT01473706
Validation of a Nutrition Screening Tool
An observational study of Malnutrition, run by Société des Produits Nestlé (SPN) at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Malnutrition
- What is being tested?
- Consumer Mini Nutritional Assessment
- How many people
- 463 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2011to Jun 2012
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Study population: Consumers aged 65 or older with or without their caregiver
Who may be able to join
- 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
Show all 9Show fewer
- 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
Who cannot join
- Consumer
- -- Full time employment
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Mini Nutritional Assessment: Consumer Validation
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.
Read the 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.
- Conditions
- Malnutrition
- Being tested
- Consumer Mini Nutritional Assessment
- Keywords
- Malnutrition, Nutrition status, Elderly, Nutrition screening
- Medical subject headings
- Malnutrition
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Consumer Mini Nutritional AssessmentOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Consumers | Adults aged ≥ 65 years; Employed part-time, unemployed, retired, full-time or a homemaker; English speaking Receives: 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 Receives: Other: Consumer Mini Nutritional Assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensitivity and the specificity (in percent) of the consumer version of the Mini Nutritional Assessment versus a validated nutrition screening tool
Measured: 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)
Measured: Within a one hour visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2011 (estimated)
- Study startAug 2011
- Primary completionJan 2012
- Study completionJun 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MalnutritionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Time perspective
- Prospective
- Enrolment
- 463 participants (actual)
Sponsor and investigators
- Lead sponsor
- Société des Produits Nestlé (SPN)
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Kerri Lehrhaupt, Principal investigator, Kantar Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01473706
- Sponsor's protocol ID
- 11.01.US.HCN
- Status last verified
- Jul 2013
- First submitted
- 10 Nov 2011
- Last updated
- 17 Jul 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mini Nutritional Assessment: Consumer Validation
- ClinicalTrials.gov ID
- NCT01473706
- Acronym / sponsor ID
- 11.01.US.HCN
- Conditions
- Malnutrition
- Keywords
- Malnutrition, Nutrition status, Elderly, Nutrition screening
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 463 participants (actual)
- Lead sponsor
- Société des Produits Nestlé (SPN)Industry (pharma, biotech, devices)
- Study start
- Aug 2011
- Primary completion
- Jan 2012 (actual)
- Study completion
- Jun 2012 (actual)
- First posted
- 17 Nov 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Consumers | – | Other: Consumer Mini Nutritional AssessmentAdults aged ≥ 65 years; Employed part-time, unemployed, retired, full-time or a homemaker; English speaking |
| Caregivers of Consumers | – | Other: Consumer Mini Nutritional AssessmentFamily, 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 |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
- Study population
- Consumers aged 65 or older with or without their caregiver
Key inclusion criteria (9 listed)
- Consumer
- Age ≥ 65 years
- Employed part-time, unemployed, retired, full-time homemaker
- English speaking
- Family, relative, friend, professional caregiver of an individual age ≥ 65 years
Key exclusion criteria (2 listed)
- Consumer
- -- Full time employment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Consumer Mini Nutritional AssessmentA 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. | Other | Caregivers of Consumers, Consumers |
Primary outcome
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
1 secondary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jul 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kerri Lehrhaupt principal investigator
Kantar Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Malnutrition, run by Société des Produits Nestlé (SPN) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Jul 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jul 2013.