Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12612000328875
Ethics application status
Approved
Date submitted
19/03/2012
Date registered
22/03/2012
Date last updated
22/03/2012
Type of registration
Retrospectively registered

Titles & IDs
Public title
Malnutrition risk in newly hospitalized obese individuals
Scientific title
Obese malnourished vs. obese adequately nourished newly hospitalized patients: effects on duration of hospitalization and in-hospital mortality
Secondary ID [1] 280167 0
Nil
Universal Trial Number (UTN)
U1111-1129-2317
Trial acronym
Mr NOI
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Obesity 286096 0
Malnutrition 286097 0
Condition category
Condition code
Diet and Nutrition 286289 286289 0 0
Obesity
Diet and Nutrition 286290 286290 0 0
Other diet and nutrition disorders

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Nutrition status defined by the Nutrition Risk Screen 2002 malnourished vs. adequately nourished patients. Patients are screened on a single occasion, within 24 hours after admission to the hospital. Data acquisition continued for a period of 5 weeks total, and our goal was to screen all adults newly admitted to internal medicine and surgical departments at E. Wolfson Medical Center, Holon, Israel.
Intervention code [1] 284496 0
Not applicable
Comparator / control treatment
no treatment
Control group
Uncontrolled

Outcomes
Primary outcome [1] 286760 0
Duration of hospitalization
Timepoint [1] 286760 0
Until discharge or in-hospital death
Secondary outcome [1] 296602 0
In hospital death
Timepoint [1] 296602 0
Until death or discharge from hospital

Eligibility
Key inclusion criteria
Admission to hospital for any reason. All newly hospitalized patients are eligible. Obesity is defined as BMI 30 kg/m sq or more; overweight is defined as BMI 25-30 kg/m sq. Normal BMI is defined as BMI 18.5-24.99 kg/m sq.
Minimum age
18 Years
Maximum age
110 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Pregnancy; outpatient status; discharge prior to performance of nutrition screen

Study design
Purpose
Screening
Duration
Cross-sectional
Selection
Convenience sample
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
17/03/2011
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
500
Accrual to date
Final
Recruitment outside Australia
Country [1] 4207 0
Israel
State/province [1] 4207 0

Funding & Sponsors
Funding source category [1] 284916 0
Self funded/Unfunded
Name [1] 284916 0
Country [1] 284916 0
Israel
Primary sponsor type
Hospital
Name
E. Wolfson Medical Center
Address
Halohamim 62
Holon
58100
Country
Israel
Secondary sponsor category [1] 283791 0
None
Name [1] 283791 0
Address [1] 283791 0
Country [1] 283791 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 286916 0
Helsinki Committee, Institutional Review Board, E. Wolfson Medical Center
Ethics committee address [1] 286916 0
E. Wolfson Medical Center
62 Halohamim St.
Holon 58100
Ethics committee country [1] 286916 0
Israel
Date submitted for ethics approval [1] 286916 0
15/11/2010
Approval date [1] 286916 0
31/12/2010
Ethics approval number [1] 286916 0
0218-10-WOMC

Summary
Brief summary
Malnutrition is prevalent among 20-50% of hospitalized individuals, particularly among the elderly and those with chronic disease. The co-existence of malnutrition in obese, newly hospitalized patients has not been evaluated. This study was designed to estimate malnutrition prevalence among newly hospitalized overweight and obese patients; to characterize malnutrition by body weight category; and to assess the degree to which elevated BMI protects individuals from malnutrition and its manifestations such as length of hospitalization. For a period of five weeks, all adults newly admitted to internal medicine and surgical departments at the E. Wolfson Medical Center, Holon, Israel, were screened for malnutrition risk using the Nutrition Risk Screen 2002 (NRS 2002). Malnutrition was compared between overweight/obese patients and normal weight patients. Overweight/obese patients were compared by malnutrition status (malnourished vs. adequately nourished).
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 33940 0
Address 33940 0
Country 33940 0
Phone 33940 0
Fax 33940 0
Email 33940 0
Contact person for public queries
Name 17187 0
Mona Boaz
Address 17187 0
Epidemiology and Research Unit
E. Wolfson Medical Center
62 Halohamim St.
Holon, 58100
Country 17187 0
Israel
Phone 17187 0
+972-3-502-8384
Fax 17187 0
Email 17187 0
mboaz8@yahoo.com
Contact person for scientific queries
Name 8115 0
Mona Boaz
Address 8115 0
Epidemiology and Research Unit
E. Wolfson Medical Center
62 Halohamim St.
Holon, 58100
Country 8115 0
Israel
Phone 8115 0
+972-3-502-8384
Fax 8115 0
Email 8115 0
mboaz8@yahoo.com

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
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