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The Undernourished Patient: Prevention and Treatment

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2014 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: May 15, 2014
Last verified: May 2014
  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: December 2014
Estimated Primary Completion Date: October 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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: May 15, 2014
Health Authority: Norway: Regional Committee for Medical and Health Research Ethics

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

ClinicalTrials.gov processed this record on November 20, 2014