MalnutritionNCT03131856
Nutritional Intervention in Geriatric Patients
A study testing Nutritional intervention programme in people with Malnutrition, run by University Hospital, Gentofte, Copenhagen.
Trial summary
This study aims to investigate the effect of a multi-disciplinary nutritional intervention program in geriatric nutritional at risk patients. The study is carried out as randomized controlled trial. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Malnutrition
- What is being tested?
- Nutritional intervention programme
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- No sites listed yet
- Study dates
- 15 Oct 2012to 31 Dec 2015
- Phase
- Interventional
- 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 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Age 65 or above
- BMI <20.5 and/or weight loss within the last 3 months and/or a reduced dietary intake in the previous week and/or severely ill
Who cannot join
- Terminal illness
- Active cancer diagnosis
- Permanently living in a nursing home
- Not willing or able to give an informed consent.
About this study
Official title: A Multidisciplinary Nutritional Intervention Programme Across Sectors to Improve the Nutritional Status of Geriatric Patients at Nutritional Risk - A Randomized Controlled Trial.
This study aims to investigate the effect of a multi-disciplinary nutritional intervention program in geriatric nutritional at risk patients. The study is carried out as randomized controlled trial. The intervention consists of an individual dietary plan conducted by a clinical dietician before discharge in combination with three follow-up visits after discharge (1, 4 and 8 weeks).
- Conditions
- Malnutrition
- Being tested
- Nutritional intervention programme
- Keywords
- Geriatrics, Nutritional risk, Multi-disciplinary intervention, Randomized Controlled Trial
- Medical subject headings
- Malnutrition
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nutritional intervention programmeBehavioural
The intervention consisted of an individual dietary plan conducted by a clinical dietician before discharge in combination with three follow-up visits after discharge (1, 4 and 8 weeks) conducted by a district nurse.
| Study group | Role | What they receive |
|---|---|---|
| Nutritional intervention programme | Experimental | An individual dietary plan conducted by a clinical dietician before discharge in combination with three follow-up visits after discharge (1, 4 and 8 weeks). Receives: Behavioral: Nutritional intervention programme |
| Usual care | No intervention | Usual care which means no individual dietary plan and no nutrition follow-up visits after discharge. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Nutritional status
Change in body weight (kg)
Measured: Three months follow-up
Secondary outcomes (5)
Functional status
Barthel Index (scale 0-100)
Measured: Three months follow-up
Functional status
Handgrip strength (kg)
Measured: Three months follow-up
Self-rated health
Self-rated health was measured with one single question with 5 possible responses on a Likert scale: In general, how would you rate your Health?
Measured: Three months follow-up
Re-admission
All-cause unplanned readmissions
Measured: Up to three months
Mortality
All-cause mortality
Measured: 1) Up to 90 days after discharge 2) Up to 120 days after discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2017
- Study start15 Oct 2012
- Primary completion17 Aug 2015
- Study completion31 Dec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MalnutritionStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Eligible patients were randomized to either the intervention group or control group.
- Masking
- None (open label)
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Gentofte, Copenhagen
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rikke Terp, University Hospital, Gentofte, Copenhagen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03131856
- Sponsor's protocol ID
- Geriatric-Project-2012
- Status last verified
- Apr 2017
- First submitted
- 31 Mar 2017
- Last updated
- 27 Apr 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multidisciplinary Nutritional Intervention Programme Across Sectors to Improve the Nutritional Status of Geriatric Patients at Nutritional Risk - A Randomized Controlled Trial.
- ClinicalTrials.gov ID
- NCT03131856
- Acronym / sponsor ID
- Geriatric-Project-2012
- Conditions
- Malnutrition
- Keywords
- Geriatrics, Nutritional risk, Multi-disciplinary intervention, Randomized Controlled Trial
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- University Hospital, Gentofte, CopenhagenUniversity, hospital or other
- Study start
- 15 Oct 2012 (actual)
- Primary completion
- 17 Aug 2015 (actual)
- Study completion
- 31 Dec 2015 (actual)
- First posted
- 27 Apr 2017 (actual)
- 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.
This study aims to investigate the effect of a multi-disciplinary nutritional intervention program in geriatric nutritional at risk patients. The study is carried out as randomized controlled trial. The intervention consists of an individual dietary plan conducted by a clinical dietician before discharge in combination with three follow-up visits after discharge (1, 4 and 8 weeks).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Eligible patients were randomized to either the intervention group or control group.
| Arm | Type | Receives |
|---|---|---|
| Nutritional intervention programme | Experimental | Behavioral: Nutritional intervention programmeAn individual dietary plan conducted by a clinical dietician before discharge in combination with three follow-up visits after discharge (1, 4 and 8 weeks). |
| Usual care | No intervention | –Usual care which means no individual dietary plan and no nutrition follow-up visits after discharge. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (2 listed)
- Age 65 or above
- BMI <20.5 and/or weight loss within the last 3 months and/or a reduced dietary intake in the previous week and/or severely ill
Key exclusion criteria (4 listed)
- Terminal illness
- Active cancer diagnosis
- Permanently living in a nursing home
- Not willing or able to give an informed consent.
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 intervention programmeThe intervention consisted of an individual dietary plan conducted by a clinical dietician before discharge in combination with three follow-up visits after discharge (1, 4 and 8 weeks) conducted by a district nurse. | Behavioural | Nutritional intervention programme |
Primary outcome
Nutritional status
Time frame: Three months follow-up
Change in body weight (kg)
5 secondary outcomes
Functional status
Time frame: Three months follow-up
Functional status
Time frame: Three months follow-up
Self-rated health
Time frame: Three months follow-up
Re-admission
Time frame: Up to three months
Mortality
Time frame: 1) Up to 90 days after discharge 2) Up to 120 days after discharge
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 27 Apr 2017.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Nutritional intervention programme in people with Malnutrition, run by University Hospital, Gentofte, Copenhagen.
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 2 inclusion and 4 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 27 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.
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.
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?
Nutritional status (time frame: Three months follow-up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 27 Apr 2017.