NCT01632072

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Jun 2012

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2012

Completed
27 days until next milestone

First Submitted

Initial submission to the registry

June 28, 2012

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 29, 2012

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2015

Completed
Last Updated

September 19, 2017

Status Verified

September 1, 2017

Enrollment Period

3.2 years

First QC Date

June 28, 2012

Last Update Submit

September 18, 2017

Conditions

Weight Loss

Outcome Measures

Primary Outcomes (1)

  • Body weight change

    Baseline and 3 months

Study Arms (2)

Nutritional counseling

EXPERIMENTAL

Dietary supplement

Dietary Supplement: Nutritional support

No nutritional counceling

NO INTERVENTION

Interventions

Nutritional supportDIETARY_SUPPLEMENT

Nutritional support and counseling

Nutritional counseling

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • Unwilling to participate
  • Less than 12 months life expectancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Godthaab rehabilitation center

Bekkestua, 1356, Norway

Location

Related Publications (1)

  • 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.

    PMID: 28717811DERIVED

Related Links

MeSH Terms

Conditions

Weight Loss

Interventions

Nutritional Support

Condition Hierarchy (Ancestors)

Body Weight ChangesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Nutrition TherapyTherapeutics

Study Officials

  • Per O Iversen, MD

    University of Oslo

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

June 28, 2012

First Posted

June 29, 2012

Study Start

June 1, 2012

Primary Completion

August 1, 2015

Study Completion

August 1, 2015

Last Updated

September 19, 2017

Record last verified: 2017-09

Locations

NO(1)