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
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
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
[email protected]
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
[email protected]

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
No additional documents have been identified.