MalnutritionNCT03928548
Malnutrition Clinical Characteristics Validation and Staffing Optimization Study (MCC Study)
An observational study of Malnutrition, run by Academy of Nutrition and Dietetics at 2 sites in United States.
Trial summary
The purpose of this study is to establish the validity of the adult and pediatric Malnutrition Clinical Characteristics (MCC). In addition, this project will: examine the relationship between the MCC and an objective measure of body composition; and establish the relationship between in-patient Registered Dietitian… Read more about this study
- Who is it for?
- Ages 1 month and olderHealthy volunteers can take part
- Conditions the study is for
- Malnutrition
- How many people
- 887 participants
- Where
- 2 sitesUnited States
- Study dates
- 24 Jun 2019to 31 Dec 2022
- 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 1 month and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: All eligible patients (according to the inclusion and exclusion criteria seen below) who are admitted to the participating hospitals in the United States.
Who may be able to join
- Adult and pediatric acute care patients at participating facility
- Newly identified as needing in-patient nutrition care through current facility policy
- Receive initial nutrition care one day before study enrollment day
- Patient is over one month of age, including infants, children, teenagers and adult patients who are intubated and/or sedated
- Patient, parent, legal guardian or legally authorized representative provide informed consent; children 7 and older provide assent
- Patient and/or parent, legal guardian or legally authorized representative are fluent in English or Spanish
Who cannot join
- Received nutrition care previously during current admission
- Pregnant women
- Prisoners
- Infants currently in the neonatal intensive care unit (NICU) with a diagnosis of prematurity
- Neonates of uncertain viability or non-viable neonates
- Patients receiving palliative/hospice care
- Patient admitted for long-term acute care (LTAC)
Trial locations and contacts
2 sites in 1 country.
United States2 sites
AdventHealth
Daytona Beach, Florida, 32117
The Children's Mercy Hospital
Kansas City, Kansas, 64108
About this study
Official title: Malnutrition Clinical Characteristics Validation and Staffing Optimization Study
The purpose of this study is to establish the validity of the adult and pediatric Malnutrition Clinical Characteristics (MCC). In addition, this project will: examine the relationship between the MCC and an objective measure of body composition; and establish the relationship between in-patient Registered Dietitian Nutritionist (RDN) care and medical outcomes for all in-patients requiring nutrition care, and specifically for malnourished patients. Sixty pediatric and 60 adult in-patient acute care facilities will participate in this research study. The total number of participants enrolled across the 120 facilities will be between 2400-9600.
The aims of the study include:
- Assess the interrater reliability of the MCC.
- Determine the predictive validity of the adult and pediatric MCC relative to a portfolio of patient medical outcomes.
- Determine the relationship between the adult and pediatric MCC and body composition measurements conducted via bioelectrical impedance analysis (BIA) in a subset of patients.
- Identify the utility of BIA for body composition analysis in clinical settings.
- Estimate the level of RDN care necessary to improve patient outcomes within the portfolio of outcomes. Specifically: quantify the dose (minutes of care and frequency of encounters) of RDN care that is associated with improved medical outcomes in patients already identified as requiring nutrition care, after adjusting for disease severity and other potential confounders.
- Identify the additional level of RDN care necessary to improve the medical outcomes in patients who have been identified as malnourished using the MCC.
- Conditions
- Malnutrition
- Medical subject headings
- Malnutrition
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Low Risk Malnutrition | Participants who are determined to be at low risk for malnutrition based on the Malnutrition Screening Tool (adults) or the STRONGkids (pediatrics). | |
| High Risk Malnutrition | Participants who are determined to be at high risk for malnutrition based on the Malnutrition Screening Tool (adults) or the STRONGkids (pediatrics). |
What is being measured
The primary outcome is the main question the study is designed to answer.
Length of stay
Number of days a participant is in-patient at an acute care hospital (discharge date - admission date) as measured by the existing medical record
Measured: 90 Days
Post-discharge readmissions
Number of times a participant is readmitted to the hospital after the initial discharge as measured by the existing medical record
Measured: 90 Days
Post discharge emergency department (ED) visits
Number of times a participant visits the ED after the initial discharge as measured by the existing medical record
Measured: 90 Days
Mortality
Participant death as measured by the existing medical record
Measured: 90 Days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2019
- Study start24 Jun 2019
- Primary completion1 Aug 2022
- Study completion31 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- 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
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 887 participants (actual)
Sponsor and investigators
- Lead sponsor
- Academy of Nutrition and Dietetics
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Alison Steiber, PhD, RDN, Principal investigator, Academy of Nutrition and Dietetics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03928548
- Sponsor's protocol ID
- 18-594
- Status last verified
- Jan 2023
- First submitted
- 10 Apr 2019
- Last updated
- 31 Jan 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Jimenez EY, Lamers-Johnson E, Long JM, McCabe G, Ma X, Woodcock L, Bliss C, Abram JK, Steiber AL. Predictive validity of the Academy of Nutrition and Dietetics/American Society for Parenteral and Enteral Nutrition indicators to diagnose malnutrition tool in hospitalized adults: a cohort study. Am J Clin Nutr. 2024 Mar;119(3):779-787. doi: 10.1016/j.ajcnut.2023.12.012. Epub 2024 Feb 12.
PubMed 38432715Jimenez EY, Lamers-Johnson E, Long JM, Mordarski BA, Ma X, Steiber A. Completion of a Nutrition-Focused Physical Exam with hospitalized adults and pediatric patients: Secondary analysis of a prospective cohort study. Nutr Clin Pract. 2024 Aug;39(4):888-902. doi: 10.1002/ncp.11137. Epub 2024 Feb 19.
PubMed 38372592Lamers-Johnson E, Will VK, Long JM, Woodcock L, Kelley K, Steiber AL, Jimenez EY. Factors Associated with IRB Review Time in a Non-Federally Funded Study Using an sIRB of Record. Ethics Hum Res. 2023 Jul-Aug;45(4):16-29. doi: 10.1002/eahr.500173.
PubMed 37368522Jimenez EY, Long JM, Lamers-Johnson E, Woodcock L, Bliss C, Lee J, Scott Parrott J, Hand RK, Kelley K, Abram JK, Steiber A. Academy of Nutrition and Dietetics Nutrition Research Network: Rationale and Protocol for a Study to Validate the Academy of Nutrition and Dietetics/American Society for Parenteral and Enteral Nutrition Consensus-Derived Diagnostic Indicators For Adult And Pediatric Malnutrition and to Determine Optimal Registered Dietitian Nutritionist Staffing in Acute Care Hospital Settings. J Acad Nutr Diet. 2022 Mar;122(3):630-639. doi: 10.1016/j.jand.2021.03.017. Epub 2021 May 4.
PubMed 33962901
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Malnutrition Clinical Characteristics Validation and Staffing Optimization Study
- ClinicalTrials.gov ID
- NCT03928548
- Acronym / sponsor ID
- 18-594
- Conditions
- Malnutrition
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 887 participants (actual)
- Lead sponsor
- Academy of Nutrition and DieteticsUniversity, hospital or other
- Study start
- 24 Jun 2019 (actual)
- Primary completion
- 1 Aug 2022 (actual)
- Study completion
- 31 Dec 2022 (actual)
- First posted
- 26 Apr 2019 (actual)
- 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 establish the validity of the adult and pediatric Malnutrition Clinical Characteristics (MCC). In addition, this project will: examine the relationship between the MCC and an objective measure of body composition; and establish the relationship between in-patient Registered Dietitian Nutritionist (RDN) care and medical outcomes for all in-patients requiring nutrition care, and specifically for malnourished patients. Sixty pediatric and 60 adult in-patient acute care facilities will participate in this research study. The total number of participants enrolled across the 120 facilities will be between 2400-9600.
The aims of the study include:
- Assess the interrater reliability of the MCC.
- Determine the predictive validity of the adult and pediatric MCC relative to a portfolio of patient medical outcomes.
- Determine the relationship between the adult and pediatric MCC and body composition measurements conducted via bioelectrical impedance analysis (BIA) in a subset of patients.
- Identify the utility of BIA for body composition analysis in clinical settings.
- Estimate the level of RDN care necessary to improve patient outcomes within the portfolio of outcomes. Specifically: quantify the dose (minutes of care and frequency of encounters) of RDN care that is associated with improved medical outcomes in patients already identified as requiring nutrition care, after adjusting for disease severity and other potential confounders.
- Identify the additional level of RDN care necessary to improve the medical outcomes in patients who have been identified as malnourished using the MCC.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Low Risk Malnutrition | – | –Participants who are determined to be at low risk for malnutrition based on the Malnutrition Screening Tool (adults) or the STRONGkids (pediatrics). |
| High Risk Malnutrition | – | –Participants who are determined to be at high risk for malnutrition based on the Malnutrition Screening Tool (adults) or the STRONGkids (pediatrics). |
Who may qualify
- Ages
- 1 month and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All eligible patients (according to the inclusion and exclusion criteria seen below) who are admitted to the participating hospitals in the United States.
Key inclusion criteria (6 listed)
- Adult and pediatric acute care patients at participating facility
- Newly identified as needing in-patient nutrition care through current facility policy
- Receive initial nutrition care one day before study enrollment day
- Patient is over one month of age, including infants, children, teenagers and adult patients who are intubated and/or sedated
- Patient, parent, legal guardian or legally authorized representative provide informed consent; children 7 and older provide assent
Key exclusion criteria (7 listed)
- Received nutrition care previously during current admission
- Pregnant women
- Prisoners
- Infants currently in the neonatal intensive care unit (NICU) with a diagnosis of prematurity
- Neonates of uncertain viability or non-viable neonates
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Length of stay
Time frame: 90 Days
Number of days a participant is in-patient at an acute care hospital (discharge date - admission date) as measured by the existing medical record
Post-discharge readmissions
Time frame: 90 Days
Number of times a participant is readmitted to the hospital after the initial discharge as measured by the existing medical record
Post discharge emergency department (ED) visits
Time frame: 90 Days
Number of times a participant visits the ED after the initial discharge as measured by the existing medical record
Mortality
Time frame: 90 Days
Participant death as measured by the existing medical record
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 31 Jan 2023.
- Derived from this study: PubMed 38432715Jimenez EY, Lamers-Johnson E, Long JM, McCabe G, Ma X, Woodcock L, Bliss C, Abram JK, Steiber AL. Predictive validity of the Academy of Nutrition and Dietetics/American Society for Parenteral and Enteral Nutrition indicators to diagnose malnutrition tool in hospitalized adults: a cohort study. Am J Clin Nutr. 2024 Mar;119(3):779-787. doi: 10.1016/j.ajcnut.2023.12.012. Epub 2024 Feb 12.
- Derived from this study: PubMed 38372592Jimenez EY, Lamers-Johnson E, Long JM, Mordarski BA, Ma X, Steiber A. Completion of a Nutrition-Focused Physical Exam with hospitalized adults and pediatric patients: Secondary analysis of a prospective cohort study. Nutr Clin Pract. 2024 Aug;39(4):888-902. doi: 10.1002/ncp.11137. Epub 2024 Feb 19.
- Derived from this study: PubMed 37368522Lamers-Johnson E, Will VK, Long JM, Woodcock L, Kelley K, Steiber AL, Jimenez EY. Factors Associated with IRB Review Time in a Non-Federally Funded Study Using an sIRB of Record. Ethics Hum Res. 2023 Jul-Aug;45(4):16-29. doi: 10.1002/eahr.500173.
- Derived from this study: PubMed 33962901Jimenez EY, Long JM, Lamers-Johnson E, Woodcock L, Bliss C, Lee J, Scott Parrott J, Hand RK, Kelley K, Abram JK, Steiber A. Academy of Nutrition and Dietetics Nutrition Research Network: Rationale and Protocol for a Study to Validate the Academy of Nutrition and Dietetics/American Society for Parenteral and Enteral Nutrition Consensus-Derived Diagnostic Indicators For Adult And Pediatric Malnutrition and to Determine Optimal Registered Dietitian Nutritionist Staffing in Acute Care Hospital Settings. J Acad Nutr Diet. 2022 Mar;122(3):630-639. doi: 10.1016/j.jand.2021.03.017. Epub 2021 May 4.
- Individual participant dataSharing planned: No
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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.
Alison Steiber, PhD, RDN principal investigator
Academy of Nutrition and Dietetics
2 sites 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 Academy of Nutrition and Dietetics at 2 sites 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 6 inclusion and 7 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 31 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Length of stay (time frame: 90 Days). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03928548, which also lists 4 linked publications.
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 31 Jan 2023; AzTrials last refreshed its copy on 4 Nov 2026.