Back to resultsThe Undernourished Patient: Prevention and Treatment
Primary Purpose
Weight Loss
Status
Completed
Phase
Phase 2
Locations
Norway
Study Type
Interventional
Intervention
Nutritional support
Sponsored by
About this trial
This is an interventional prevention trial for Weight Loss
Eligibility Criteria
Inclusion Criteria:
- In risk of undernutrition or undernourished according to the screening tool NRS-2002, score 3 or above.
- Living in Oslo, Bærum or Asker municipality.
- Must be able to cooperate.
Exclusion Criteria:
- Unwilling to participate
- Less than 12 months life expectancy
Sites / Locations
- Godthaab rehabilitation center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Nutritional counseling
No nutritional counceling
Arm Description
Dietary supplement
Outcomes
Primary Outcome Measures
Body weight change
Secondary Outcome Measures
Full Information
NCT ID
NCT01632072
First Posted
June 28, 2012
Last Updated
September 18, 2017
Sponsor
University of Oslo
Collaborators
Godthaab rehabilitation centre
1. Study Identification
Unique Protocol Identification Number
NCT01632072
Brief Title
The Undernourished Patient: Prevention and Treatment
Official Title
The Undernourished Patient: Prevention and Treatment
Study Type
Interventional
2. Study Status
Record Verification Date
September 2017
Overall Recruitment Status
Completed
Study Start Date
June 2012 (undefined)
Primary Completion Date
August 2015 (Actual)
Study Completion Date
August 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Oslo
Collaborators
Godthaab rehabilitation centre
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to determine whether a nutrition intervention during a rehabilitation stay followed by nutritional advice after discharge, can improve the nutritional status of the patients after 3 months.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Weight Loss
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Nutritional counseling
Arm Type
Experimental
Arm Description
Dietary supplement
Arm Title
No nutritional counceling
Arm Type
No Intervention
Intervention Type
Dietary Supplement
Intervention Name(s)
Nutritional support
Intervention Description
Nutritional support and counseling
Primary Outcome Measure Information:
Title
Body weight change
Time Frame
Baseline and 3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
In risk of undernutrition or undernourished according to the screening tool NRS-2002, score 3 or above.
Living in Oslo, Bærum or Asker municipality.
Must be able to cooperate.
Exclusion Criteria:
Unwilling to participate
Less than 12 months life expectancy
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Per O Iversen, MD
Organizational Affiliation
University of Oslo
Official's Role
Principal Investigator
Facility Information:
Facility Name
Godthaab rehabilitation center
City
Bekkestua
ZIP/Postal Code
1356
Country
Norway
12. IPD Sharing Statement
Citations:
PubMed Identifier
28717811
Citation
Andersson J, Hulander E, Rothenberg E, Iversen PO. Effect on Body Weight, Quality of Life and Appetite Following Individualized, Nutritional Counselling to Home-Living Elderly after Rehabilitation - An Open Randomized Trial. J Nutr Health Aging. 2017;21(7):811-818. doi: 10.1007/s12603-016-0825-8.
Results Reference
derived
Links:
URL
https://www.ncbi.nlm.nih.gov/pubmed/?term=Ole+Iversen+P
Description
Published paper
Learn more about this trial
The Undernourished Patient: Prevention and Treatment
We'll reach out to this number within 24 hrs