The Undernourished Patient: Prevention and Treatment

NCT ID: NCT01632072

Last Updated: 2017-09-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-06-30

Study Completion Date

2015-08-31

Brief Summary

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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.

Detailed Description

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Conditions

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Weight Loss

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Nutritional counseling

Dietary supplement

Group Type EXPERIMENTAL

Nutritional support

Intervention Type DIETARY_SUPPLEMENT

Nutritional support and counseling

No nutritional counceling

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Nutritional support

Nutritional support and counseling

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Godthaab rehabilitation centre

UNKNOWN

Sponsor Role collaborator

University of Oslo

OTHER

Sponsor Role lead

Responsible Party

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Per Ole Iversen, MD

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Per O Iversen, MD

Role: PRINCIPAL_INVESTIGATOR

University of Oslo

Locations

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Godthaab rehabilitation center

Bekkestua, , Norway

Site Status

Countries

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Norway

References

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Andersson J, Hulander E, Rothenberg E, Iversen PO. Effect on Body Weight, Quality of Life and Appetite Following Individualized, Nutritional Counselling to Home-Living Elderly after Rehabilitation - An Open Randomized Trial. J Nutr Health Aging. 2017;21(7):811-818. doi: 10.1007/s12603-016-0825-8.

Reference Type DERIVED
PMID: 28717811 (View on PubMed)

Related Links

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Other Identifiers

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2012/928

Identifier Type: -

Identifier Source: org_study_id