The Undernourished Patient: Prevention and Treatment

September 18, 2017 updated by: Per Ole Iversen, MD, University of Oslo
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

100

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Norway
      • Bekkestua, Norway, 1356
        • Godthaab rehabilitation center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Nutritional counseling
Dietary supplement
Dietary supplement: Nutritional support
Nutritional support and counseling
No Intervention: No nutritional counceling

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Body weight change
Time Frame: Baseline and 3 months
Baseline and 3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Oslo

Collaborators

Godthaab rehabilitation centre

Investigators

  • Principal Investigator: Per O Iversen, MD, University of Oslo

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2012

Primary Completion (Actual)

August 1, 2015

Study Completion (Actual)

August 1, 2015

Study Registration Dates

First Submitted

June 28, 2012

First Submitted That Met QC Criteria

June 28, 2012

First Posted (Estimate)

June 29, 2012

Study Record Updates

Last Update Posted (Actual)

September 19, 2017

Last Update Submitted That Met QC Criteria

September 18, 2017

Last Verified

September 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2012/928

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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