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The Undernourished Patient: Prevention and Treatment

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ClinicalTrials.gov Identifier: NCT01632072
Recruitment Status : Completed
First Posted : June 29, 2012
Last Update Posted : September 19, 2017
Sponsor:
Collaborator:
Godthaab rehabilitation centre
Information provided by (Responsible Party):
Per Ole Iversen, MD, University of Oslo

Tracking Information
First Submitted Date  ICMJE June 28, 2012
First Posted Date  ICMJE June 29, 2012
Last Update Posted Date September 19, 2017
Study Start Date  ICMJE June 2012
Actual Primary Completion Date August 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 29, 2012)
Body weight change [ Time Frame: Baseline and 3 months ]
Original Primary Outcome Measures  ICMJE
 (submitted: June 28, 2012)
Body weight change [ Time Frame: 3 months ]
Change History Complete list of historical versions of study NCT01632072 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The Undernourished Patient: Prevention and Treatment
Official Title  ICMJE The Undernourished Patient: Prevention and Treatment
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE Weight Loss
Intervention  ICMJE Dietary Supplement: Nutritional support
Nutritional support and counseling
Study Arms  ICMJE
  • Experimental: Nutritional counseling
    Dietary supplement
    Intervention: Dietary Supplement: Nutritional support
  • No Intervention: No nutritional counceling
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 29, 2012)
100
Original Enrollment  ICMJE Not Provided
Actual Study Completion Date  ICMJE August 2015
Actual Primary Completion Date August 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. In risk of undernutrition or undernourished according to the screening tool NRS-2002, score 3 or above.
  2. Living in Oslo, Bærum or Asker municipality.
  3. Must be able to cooperate.

Exclusion Criteria:

  1. Unwilling to participate
  2. Less than 12 months life expectancy
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Norway
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01632072
Other Study ID Numbers  ICMJE 2012/928
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Per Ole Iversen, MD, University of Oslo
Study Sponsor  ICMJE University of Oslo
Collaborators  ICMJE Godthaab rehabilitation centre
Investigators  ICMJE
Principal Investigator: Per O Iversen, MD University of Oslo
PRS Account University of Oslo
Verification Date September 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP