The Undernourished Patient: Prevention and Treatment

This study is currently recruiting participants.
Verified November 2013 by University of Oslo
Sponsor:
Collaborator:
Godthaab rehabilitation centre
Information provided by (Responsible Party):
Per Ole Iversen, MD, University of Oslo
ClinicalTrials.gov Identifier:
NCT01632072
First received: June 28, 2012
Last updated: November 14, 2013
Last verified: November 2013
  Purpose

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.


Condition Intervention Phase
Weight Loss
Dietary Supplement: Nutritional support
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: The Undernourished Patient: Prevention and Treatment

Resource links provided by NLM:


Further study details as provided by University of Oslo:

Primary Outcome Measures:
  • Body weight change [ Time Frame: Baseline and 3 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 100
Study Start Date: June 2012
Estimated Study Completion Date: March 2014
Estimated Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Nutritional counseling
Dietary supplement
Dietary Supplement: Nutritional support
Nutritional support and counseling
No Intervention: No nutritional counceling

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01632072

Contacts
Contact: Joanna Andersson, MSc 95960808 ext 47 joannaandersson@hotmail.com

Locations
Norway
Godthaab rehabilitation center Recruiting
Bekkestua, Norway, 1356
Contact: Joanna Andersson, MSc    95960808 ext 47    joannaandersson@hotmail.com   
Sponsors and Collaborators
University of Oslo
Godthaab rehabilitation centre
Investigators
Principal Investigator: Per O Iversen, MD University of Oslo
  More Information

No publications provided

Responsible Party: Per Ole Iversen, MD, Professor, University of Oslo
ClinicalTrials.gov Identifier: NCT01632072     History of Changes
Other Study ID Numbers: 2012/928
Study First Received: June 28, 2012
Last Updated: November 14, 2013
Health Authority: Norway: Regional Committee for Medical and Health Research Ethics

Additional relevant MeSH terms:
Weight Loss
Malnutrition
Body Weight Changes
Body Weight
Signs and Symptoms
Nutrition Disorders

ClinicalTrials.gov processed this record on April 22, 2014