Weight LossPhase 2NCT01632072
The Undernourished Patient: Prevention and Treatment
A Phase 2 study testing Nutritional support in people with Weight Loss, run by University of Oslo at 1 site in Norway.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Weight Loss
- What is being tested?
- Nutritional support
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteNorway
- Study dates
- Jun 2012to Aug 2015
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Unwilling to participate
- Less than 12 months life expectancy
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Weight Loss
- Being tested
- Nutritional support
- Medical subject headings
- Weight Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nutritional supportDietary supplement
Nutritional support and counseling
| Study group | Role | What they receive |
|---|---|---|
| Nutritional counseling | Experimental | Dietary supplement Receives: Dietary Supplement: Nutritional support |
| No nutritional counceling | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Body weight change
Measured: Baseline and 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2012 (estimated)
- Study startJun 2012
- Primary completionAug 2015
- Study completionAug 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Weight LossStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Oslo
- Sponsor type
- University, hospital or other
- Collaborators
- Godthaab rehabilitation centre
- Responsible party
- Principal investigator, Per Ole Iversen, MD, University of Oslo
- Investigators
- Per O Iversen, MD, Principal investigator, University of Oslo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01632072
- Sponsor's protocol ID
- 2012/928
- Status last verified
- Sep 2017
- First submitted
- 28 Jun 2012
- Last updated
- 19 Sep 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 28717811
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Undernourished Patient: Prevention and Treatment
- ClinicalTrials.gov ID
- NCT01632072
- Acronym / sponsor ID
- 2012/928
- Conditions
- Weight Loss
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- University of OsloUniversity, hospital or other
- Collaborators
- Godthaab rehabilitation centre
- Study start
- Jun 2012
- Primary completion
- Aug 2015 (actual)
- Study completion
- Aug 2015 (actual)
- First posted
- 29 Jun 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Nutritional counseling | Experimental | Dietary Supplement: Nutritional supportDietary supplement |
| No nutritional counceling | No intervention | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (2 listed)
- Unwilling to participate
- Less than 12 months life expectancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nutritional supportNutritional support and counseling | Dietary supplement | Nutritional counseling |
Primary outcome
Body weight change
Time frame: Baseline and 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2017.
- Derived from this study: PubMed 28717811Andersson 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.
- Published paperLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Per O Iversen, MD principal investigator
University of Oslo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Nutritional support in people with Weight Loss, run by University of Oslo at 1 site in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Sep 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Body weight change (time frame: Baseline and 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01632072, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2017.