MalnourishmentNCT04798807
Screening Nutritional Status of Hospitalized Patients
An observational study of Malnourishment, run by TC Erciyes University.
Trial summary
This study investigated the results of the nutritional status of hospitalized patients with Nutritional Risk Screening 2002 (NRS-2002) and Subjective Global Assessment (SGA) screening and compared the effects of two screening method in predicting malnutrition. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Malnourishment
- What is being tested?
- Nutritional screening
- How many people
- 134 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2016to 30 Aug 2016
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients who were hospitalized in the clinics (hematology, neurology, gastroenterology, nephrology, endocrine, pulmonary disease and cardiology) of Malatya Training and Research Hospital between January 1 and August 30, 2016.
Who may be able to join
- ≥18 years old
- non-bed-dependent
- non-critİcal service patients
Who cannot join
- < 18 years old,
- hospitalized due to surgical operation,
- pregnant women,
- breastfeeding women,
- bed-dependent,
- suffered an advanced disease that required palliative care.
About this study
Official title: Screening Nutritional Status of Hospitalized Patients With Nutritional Risk Screening 2002 and Subjective Global Assessment Tools
This study investigated the results of the nutritional status of hospitalized patients with Nutritional Risk Screening 2002 (NRS-2002) and Subjective Global Assessment (SGA) screening and compared the effects of two screening method in predicting malnutrition.
Read the detailed description
In the cross-sectional study demographic data, body mass index (BMI), length of hospital stay (LOS), and cause of hospitalization of hospitalized patients were recorded. For the nutritional assessment all patients were screened with NRS 2002 and SGA within the first days of admission to the patients. The primary predictors of interest in our study were the NRS 2002 and SGA results of patients.
- Conditions
- Malnourishment
- Being tested
- Nutritional screening
- Keywords
- Nutritional assessment, Nutritional Risk Screening 2002, Subjective Global Assessment.
- Medical subject headings
- Malnutrition
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nutritional screeningDiagnostic test
| Study group | Role | What they receive |
|---|---|---|
| Hospitalized non-critical services patients | Patients, who were hospitalized in the clinics (hematology, neurology, gastroenterology, nephrology, endocrine, pulmonary disease and cardiology) of Malatya Training and Research Hospital, were screened both Nutritional Risk Screening 2002 (NRS-2002) and Subjective Global Assessment (SGA) tools within the first days of admission to the patients.
The nutritional status of patients categorized according the screening tools.
Nutritional Risk Screening 2002 (NRS-2002) : The patients were classified as being nutritionally risk (NRS+): total score ≥ 3 or nutritionally risk-free (NRS-): total score < 3 according to NRS 2002 results.
Subjective Global Assessment (SGA) The SGA screening provides three alternative categories for nutritional classification: well nourished (A); mild-to-moderately malnourished (B); or severely malnourished (C). Receives: Diagnostic Test: Nutritional screening |
What is being measured
The primary outcome is the main question the study is designed to answer.
Identifying malnourishment according to the Nutritional Risk Screening 2002
The results of the Nutritional Risk Screening 2002 (NRS-2002): The patients were classified as being nutritionally risk (NRS+): total score ≥ 3 or nutritionally risk-free (NRS-): total score < 3 according to NRS 2002 results.
Measured: First 48 hours of hospitalization
Identifying malnourishment according to the Subjective Global Assessment (SGA)
The results of the Subjective Global Assessment (SGA): The SGA screening provides three alternative categories for nutritional classification: well nourished (A); mild-to-moderately malnourished (B); or severely malnourished (C).
Measured: First 48 hours of hospitalization
Compare the results of two screening tools.
Compare the results of NRS-2002 and SGA tools on predicting malnutrition and nutritional status of patients.
Measured: Through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2021
- Study start1 Jan 2016
- Primary completion30 Aug 2016
- Study completion30 Aug 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MalnourishmentStudies of the same condition, open and under way.
- More trials run by TC Erciyes UniversityThe sponsor's other registered studies.
- 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
- Cross-sectional
- Enrolment
- 134 participants (actual)
Sponsor and investigators
- Lead sponsor
- TC Erciyes University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Neşe Kaya, TC Erciyes University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04798807
- Sponsor's protocol ID
- 2016/144
- Status last verified
- Mar 2021
- First submitted
- 5 Mar 2021
- Last updated
- 15 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Screening Nutritional Status of Hospitalized Patients With Nutritional Risk Screening 2002 and Subjective Global Assessment Tools
- ClinicalTrials.gov ID
- NCT04798807
- Acronym / sponsor ID
- 2016/144
- Conditions
- Malnourishment
- Keywords
- Nutritional assessment, Nutritional Risk Screening 2002, Subjective Global Assessment.
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 134 participants (actual)
- Lead sponsor
- TC Erciyes UniversityUniversity, hospital or other
- Study start
- 1 Jan 2016 (actual)
- Primary completion
- 30 Aug 2016 (actual)
- Study completion
- 30 Aug 2016 (actual)
- First posted
- 15 Mar 2021 (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.
This study investigated the results of the nutritional status of hospitalized patients with Nutritional Risk Screening 2002 (NRS-2002) and Subjective Global Assessment (SGA) screening and compared the effects of two screening method in predicting malnutrition.
Detailed description
In the cross-sectional study demographic data, body mass index (BMI), length of hospital stay (LOS), and cause of hospitalization of hospitalized patients were recorded. For the nutritional assessment all patients were screened with NRS 2002 and SGA within the first days of admission to the patients. The primary predictors of interest in our study were the NRS 2002 and SGA results of patients.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Hospitalized non-critical services patients | – | Diagnostic Test: Nutritional screeningPatients, who were hospitalized in the clinics (hematology, neurology, gastroenterology, nephrology, endocrine, pulmonary disease and cardiology) of Malatya Training and Research Hospital, were screened both Nutritional Risk Screening 2002 (NRS-2002) and Subjective Global Assessment (SGA) tools within the first days of admission to the patients. The nutritional status of patients categorized according the screening tools. Nutritional Risk Screening 2002 (NRS-2002) : The patients were classified as being nutritionally risk (NRS+): total score ≥ 3 or nutritionally risk-free (NRS-): total score < 3 according to NRS 2002 results. Subjective Global Assessment (SGA) The SGA screening provides three alternative categories for nutritional classification: well nourished (A); mild-to-moderately malnourished (B); or severely malnourished (C). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who were hospitalized in the clinics (hematology, neurology, gastroenterology, nephrology, endocrine, pulmonary disease and cardiology) of Malatya Training and Research Hospital between January 1 and August 30, 2016.
Key inclusion criteria (3 listed)
- ≥18 years old
- non-bed-dependent
- non-critİcal service patients
Key exclusion criteria (6 listed)
- < 18 years old,
- hospitalized due to surgical operation,
- pregnant women,
- breastfeeding women,
- bed-dependent,
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 |
|---|---|---|
| Nutritional screening | Diagnostic test | Hospitalized non-critical services patients |
Primary outcome
Identifying malnourishment according to the Nutritional Risk Screening 2002
Time frame: First 48 hours of hospitalization
The results of the Nutritional Risk Screening 2002 (NRS-2002): The patients were classified as being nutritionally risk (NRS+): total score ≥ 3 or nutritionally risk-free (NRS-): total score < 3 according to NRS 2002 results.
Identifying malnourishment according to the Subjective Global Assessment (SGA)
Time frame: First 48 hours of hospitalization
The results of the Subjective Global Assessment (SGA): The SGA screening provides three alternative categories for nutritional classification: well nourished (A); mild-to-moderately malnourished (B); or severely malnourished (C).
Compare the results of two screening tools.
Time frame: Through study completion, an average of 1 year
Compare the results of NRS-2002 and SGA tools on predicting malnutrition and nutritional status of patients.
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 15 Mar 2021.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Malnourishment, run by TC Erciyes University.
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 3 inclusion and 6 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 15 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
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?
Identifying malnourishment according to the Nutritional Risk Screening 2002 (time frame: First 48 hours of hospitalization). The study lists 3 primary outcomes in all. 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 15 Mar 2021.