The Undernourished Patient: Prevention and Treatment
This study is currently recruiting participants.
Verified June 2012 by University of Oslo
Sponsor:
University of Oslo
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: June 29, 2012
Last verified: June 2012
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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 2013 |
| Estimated Primary Completion Date: | March 2013 (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:
- In risk of undernutrition or undernourished according to the screening tool NRS-2002, score 3 or above.
- Living in Oslo, Bærum or Asker municipality.
- Must be able to cooperate.
Exclusion Criteria:
- Unwilling to participate
- 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: | June 29, 2012 |
| 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 June 18, 2013