- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07514572
Impact of Estimated Weight and Height on Nutritional Assessment in Elderly
Accuracy of Estimated Weight and Height in Old Inpatients and Their Impact on Nutritional Assessment
Recording the exact weight and height should represent a standard practice for all inpatients, as they significantly impact on patients' care, drug dosing and nutritional assessment.
However, these measurements are recorded in a small percentage of inpatients and, even worse, they often are estimated by nurses or Physicians, or self-reported by patients. This error may contribute to a wrong nutritional assessment, since the body mass index (BMI) is one of the parameters included in some of the most used nutritional scores.
In this study the investigators will perform a nutritional assessement, at hospital admission, in a group of inpatients by the mini-nutritional assessment short form (MNA-SF), by means of estimated, self-reported and exact body weight measures.
Moreover, in those subjects with a malnutrition diagnosis (by MNA-SF) the investigators will perform bioimpedence analysis and will evaluate a series of anthropometric measurements offering insights into body composition and distribution of fat and muscle, such as calf, waist and hip circumference.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Patients of both sexes with free and informed consent.
- Age 65 or older (in line with the World Health Organization definition and the recommendations of the ESPEN guidelines for geriatric nutritional assessment).
Exclusion Criteria:
- Inability or unwillingness to provide informed consent.
- Severe cognitive impairment.
- Language or communication barriers.
- Clinical or logistical conditions that make objective measurement of weight and/or height impossible (e.g., non-transferable bedridden status, clinical instability, risk to the patient).
- Clinical judgment of unsuitability, at the discretion of the physician responsible for the study
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Single arm
Patients of both sexes, age 65 or older, hospitalized in the Internal Medicine 2 Admission Room of the Fondazione Policlinico Universitario Agostino Gemelli IRCCS. Description of interventions. At admission, collection of self-reported weight and height, the exact measurement of weight and height with certified instruments, the administration of the MNA-SF questionnaire and the detection of body circumferences |
Collection of self-reported weight and height, the exact measurement of weight and height with certified instruments, the administration of the MNA-SF questionnaire and the detection of body circumferences
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
To assess the impact of discrepancies between estimated weight values reported in the medical record and those exactly measured
Time Frame: At admission
|
Comparison among estimated (by nurses), self-reported (by patients) and exact body weight measures in kilograms (by nurses and physicians).
|
At admission
|
|
To assess the impact of discrepancies between estimated height values reported in the medical record and those exactly measured
Time Frame: At admission
|
Comparison among estimated (by nurses), self-reported (by patients) and exact height measures in centimeters (by nurses and physicians).
|
At admission
|
|
Differences in MNA-SF scores
Time Frame: At admission
|
Comparison among MNA-SF scores obtained using estimated, self-reported and exact weight measures in kilograms.
|
At admission
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Number of patients with a diagnosis of sarcopenia by both bioimpedance and anthropometric analysis
Time Frame: At admission
|
Evaluation of the diagnosis of sarcopenia through the comparison between bioimpedance analysis (measured in %) and anthropometric measurements (calf, hip, waist, measured in cm).
|
At admission
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- ID 8105
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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