Malnutrition Clinical Characteristics Validation and Staffing Optimization Study (MCC Study)

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

887 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-06-24

Study Completion Date

2022-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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:

1. Assess the interrater reliability of the MCC.
2. Determine the predictive validity of the adult and pediatric MCC relative to a portfolio of patient medical outcomes.
3. Determine the relationship between the adult and pediatric MCC and body composition measurements conducted via bioelectrical impedance analysis (BIA) in a subset of patients.
4. Identify the utility of BIA for body composition analysis in clinical settings.
5. 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.
6. Identify the additional level of RDN care necessary to improve the medical outcomes in patients who have been identified as malnourished using the MCC.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Malnutrition Clinical Characteristics Validation Study

NCT02182427

Malnutrition

COMPLETED

Effect of Protein Intake on Preterm Infant Body Composition

NCT02353013

Premature; Infant, Light-for-dates

COMPLETED NA

Effects of Acute Dietary Changes on Estimates of Body Composition

NCT02888405

Overweight

COMPLETED NA

Ability to Meet Enteral Nutritional Needs with a Peptide-based, High Protein Formula

NCT05025267

Enteral Feeding

COMPLETED NA

Developmental Adaptation to an Obesogenic Environment

NCT02257593

Obesity

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Malnutrition

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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).

No interventions assigned to this group

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).

No interventions assigned to this group

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* 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

Exclusion Criteria

* 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)

Minimum Eligible Age

1 Month

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes