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MalnutritionKMH2NCT06706661

Implementation of Nutritional Efforts on Discharged Older Patients

A study testing Nutritional treatment in people with Malnutrition, run by Herlev and Gentofte Hospital at 1 site in Denmark.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

The aim of the study is to implement a nutritional treatment when discharging older patients at risk of malnutrition. Data collected in the study will include an assessment of whether a combination of nutritional treatment and a liaison team reduces the risk of readmissions and mortality, improves nutritional status… Read more about this study

Who is it for?
Ages 50 years and older
Conditions the study is for
Malnutrition
What is being tested?
Nutritional treatment
Could I receive a placebo?
No, everyone receives an active treatment
How many people
2,000 participants
Where
1 siteDenmark
Study dates
6 Jan 2025to 31 Dec 2030
Phase
Interventional
Are there results?
Not yet: the study is under way

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 50 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Prescription of the Liaison team At nutritional risk according to NRS2002 Age 50+ Can read, hear and understand Danish or English Cognitive able to participate in the study, based on whether they are informed in time, place and own data

Who cannot join

  • Receives enteral or parenteral nutrition Following a special diet including texture modified food and drinks Short life expectancy Not deemed eligible by the project staff

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Tina Munk, Ph D contact

+45 61160138

tina.munk@regionh.dk

Anne Marie Beck, Ph.d. contact

+45 38682387

Denmark1 site, 1 recruiting

  • Herlev and Gentofte Hospital

    Herlev, 2730

    Anne Marie Beck, Senior researcher, +45 38682387, anne.marie.beck@regionh.dk

    Tina Munk

    Recruiting

Other trials in Denmark

About this study

Official title: Implementation of Nutritional Treatment to Older Patients Discharged With the Liaison Team

The aim of the study is to implement a nutritional treatment when discharging older patients at risk of malnutrition.

Data collected in the study will include an assessment of whether a combination of nutritional treatment and a liaison team reduces the risk of readmissions and mortality, improves nutritional status, physical function and quality of life

Read the detailed description

During hospitalization, many older patients are at risk of malnutrition. Malnutrition in older adults is related to reduced physical function, more complications, re-admissions, days in hospital and reduced quality of life. As hospitalizations are often short (approximately 5 days), it is important to focus on nutritional intake during the convalescence period.

Upon discharge, a "Nutrition Gap" often occurs in practice, where the patient does not consume sufficient nutrition to ensure an optimal convalescence period. The lack of nutritional follow-up in connection with the discharge of older patients has been shown to have a markedly negative effect on, among other things, functional ability and readmissions. A study from Herlev Hospital, where the effect of a nutritional treatment upon discharge of older patients was investigated, showed a significant effect on muscle strength, quality of life and nutritional status. Another study from Herlev Hospital has shown that by associating a clinical dietitian with a liaison team and thus focusing on nutrition, the readmission rate was halved.

The problem is that it has not been investigated whether such a cross-sectoral effort can be implemented in practice and the results confirmed.

Hypothesis 1 is that it is possible to include and retain the older patients who are discharged with the liaison team for an effort that includes treatment of the risk of malnutrition and that the older participants find the effort relevant

Hypothesis 2 is that nutritional treatment will be able to reduce the number of unintended readmissions and thereby be cost-effective. Furthermore, it is expected that the nutritional treatment will increase the participants' nutritional status, muscle strength, muscle mass, quality of life and possibly have a positive effect on mortality.

Conditions
Malnutrition
Being tested
Nutritional treatment
Keywords
food, dietician, malnutrition, nutrition risk, quality of life, muscle strength, readmissions, mortality, multimodal
Medical subject headings
Malnutrition

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Nutritional treatmentOther

    At the day of discharge the intervention group (IG) receives a package containing foods and drinks covering dietary requirements for the next 24 h. Further, a goodie-bag containing samples of protein-rich milk-based drinks is provided. At day 4 after discharge, the IG receives dietetic counselling including a recommendation of daily exercise, and an individual nutrition plan. Information regarding recommendations of nutritional therapy after discharge is systematically and electronically communicated to the municipality. The dietician performes telephone follow-ups on day 30 and a home visit at 12 weeks

Study groups in NCT06706661
Study groupRoleWhat they receive
Nutritional treamentExperimentalAt the day of discharge the intervention group (IG) receives a package containing foods and drinks covering dietary requirements for the next 24 h. Further, a goodie-bag containing samples of protein-rich milk-based drinks is provided. At day 4 after discharge, the IG receives dietetic counselling including a recommendation of daily exercise, and an individual nutrition plan. Information regarding recommendations of nutritional therapy after discharge is systematically and electronically communicated to the municipality. The dietician performes telephone follow-ups on day 30 and a home visit at 12 weeks
Receives: Other: Nutritional treatment

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Eligibility

    Eligibility will be assessed as the number of patients who fulfil the inclusion criteria out of the number of patients discharged with the liaison team

    Measured: Assessed at baseline

  2. Recruitment

    Recruitment rate will be assessed as the number of patients recruited out of the number of eligible patients

    Measured: Assessed at baseline

  3. Retention

    Retention rate will be assessed as the number of patients who complete the nutritional treatment out of the total number of patients recruited

    Measured: Assessed at three months

Secondary outcomes (8)

  1. Mortality

    health care records

    Measured: 30 days, 12 weeks, 6 monts, 1 year and 3 year

  2. Hospital re-admissions

    health care records

    Measured: 30 days, 12 weeks, 6 monts, 1 year and 3 year

  3. Health related Quality of life

    Euro-qol tool EQ5D5L

    Measured: 12 weeks

  4. Appetite

    SNAQ with a score from 5 to 20 where a score at or below 14 can predict weight loss

    Measured: 30 days, 12 weeks

  5. Muscle strenght

    30 seconds chair stand

    Measured: 4 days, 30 days, 12 weeks

  6. Dietary intake

    24 hours recall

    Measured: 30 days, 12 weeks

  7. weight

    body weight measurement

    Measured: 4 days, 30 days

  8. muscle mass

    calf circumference

    Measured: 12 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Nov 2024
  2. Study start6 Jan 2025
  3. Primary completion31 Dec 2030 (estimated)
  4. Study completion31 Dec 2030 (estimated)

Resources

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
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
2,000 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06706661
Sponsor's protocol ID
F-24065575
Acronym
KMH2
Status last verified
Jul 2026
First submitted
22 Nov 2024
Last updated
7 Jul 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: Due to GDPR

Publications

  • Beck A, Andersen UT, Leedo E, Jensen LL, Martins K, Quvang M, Rask KO, Vedelspang A, Ronholt F. Does adding a dietician to the liaison team after discharge of geriatric patients improve nutritional outcome: a randomised controlled trial. Clin Rehabil. 2015 Nov;29(11):1117-28. doi: 10.1177/0269215514564700. Epub 2014 Dec 31.

    PubMed 25552522

  • Munk T, Svendsen JA, Knudsen AW, Ostergaard TB, Thomsen T, Olesen SS, Rasmussen HH, Beck AM. A multimodal nutritional intervention after discharge improves quality of life and physical function in older patients - a randomized controlled trial. Clin Nutr. 2021 Nov;40(11):5500-5510. doi: 10.1016/j.clnu.2021.09.029. Epub 2021 Sep 24.

    PubMed 34656032

Questions about this trial

What is this clinical trial studying?

A study testing Nutritional treatment in people with Malnutrition, run by Herlev and Gentofte Hospital at 1 site in Denmark.

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 1 inclusion and 1 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: looking for participants now, as of the sponsor's last update on 7 Jul 2026. 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 Denmark. 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.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Tina Munk, Ph D (+45 61160138, tina.munk@regionh.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Eligibility (time frame: Assessed at baseline). The study lists 3 primary outcomes in all. 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 NCT06706661, which also lists 2 linked publications.

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 7 Jul 2026.

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