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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:
Information provided by (Responsible Party):

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.

Condition or disease Intervention/treatment Phase
Weight Loss Dietary Supplement: Nutritional support Phase 2

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: The Undernourished Patient: Prevention and Treatment
Study Start Date : June 2012
Primary Completion Date : August 2015
Study Completion Date : August 2015

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: Nutritional counseling
Dietary supplement
Dietary Supplement: Nutritional support
Nutritional support and counseling
No Intervention: No nutritional counceling


Outcome Measures

Primary Outcome Measures :
  1. Body weight change [ Time Frame: Baseline and 3 months ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01632072


Locations
Norway
Godthaab rehabilitation center
Bekkestua, Norway, 1356
Sponsors and Collaborators
University of Oslo
Godthaab rehabilitation centre
Investigators
Principal Investigator: Per O Iversen, MD University of Oslo
More Information

Additional Information:
Responsible Party: Per Ole Iversen, MD, Professor, University of Oslo
ClinicalTrials.gov Identifier: NCT01632072     History of Changes
Other Study ID Numbers: 2012/928
First Posted: June 29, 2012    Key Record Dates
Last Update Posted: September 19, 2017
Last Verified: September 2017

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