Malnutrition SevereDENUTADOMNCT06976827
Management of Undernutrition on Discharge From Hospital by Dieticians and Physical Activity Teachers at Home
A study testing Dietary and physical activity monitoring during the 3-months post-hospitalization period in people with Malnutrition Severe and Malnutrition; Moderate, run by Centre hospitalier Henri Mondor d'Aurillac at 1 site in France.
Trial summary
The DENUTADOM study is a single-center feasibility study. It is an interventional research project involving human subjects (RIPH2), which will lead to a change in the care and treatment of adult patients diagnosed as suffering from moderate to severe undernutrition during hospitalization. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Malnutrition Severe, Malnutrition; Moderate
- What is being tested?
- Dietary and physical activity monitoring during the 3-months post-hospitalization period
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 27 participants
- Where
- 1 siteFrance
- Study dates
- 15 May 2025to 31 Dec 2025
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Moderately or severely malnourished adult patient according to HAS diagnostic criteria: At least one phenotypic criterion: weight loss (> 5% in 1 month, > 10% in 6 months or relative to pre-disease weight), BMI < 18.5 in < 70 years or BMI < 22 in ≥ 70 years, reduced muscle mass and/or function AND At least one etiological criterion: reduction in food intake > 50% for > 7 days or > 14 days regardless of reduction, reduced absorption, aggressive situation with hypercatabolism
- Patient with an attending physician wishing to participate in the study
- Patient wishing to be followed by a private dietician participating in the study
Who cannot join
- Patients with cognitive disorders
- Patients with eating disorders
- Pregnant or breast-feeding patient
- Patient with an estimated life expectancy of less than 6 months (at investigator's discretion)
- Patient under legal protection
- Patient not affiliated to the social security system
- Patient who has not signed a free, written and informed consent form
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site
Centre hospitalier Henri Mondor d'Aurillac
Aurillac, 15000
Pauline LOSORGIO-PETITJEAN, MSc, +33 04 71 46 56 13, p.losorgio-petitjean@ch-aurillac.fr
Arnaud VILANOVA, MD
About this study
Official title: Prise en Charge de la dénutrition en Sortie d'Hospitalisation Par Des diététiciennes et Des Enseignants en activité Physique adapté à Domicile : étude de faisabilité (DENUTADOM)
The DENUTADOM study is a single-center feasibility study. It is an interventional research project involving human subjects (RIPH2), which will lead to a change in the care and treatment of adult patients diagnosed as suffering from moderate to severe undernutrition during hospitalization. The aim of this study was to assess patient compliance with a new undernutrition management program (diet and physical activity) at discharge from hospital.
In this study, during hospitalization, patients may be included in the study if they meet the inclusion criteria. To this end, the physician will offer to participate in the study, and will provide the patient with an information document. If the patient agrees to take part, he or she will be included in the study after signing the consent form. Participation will last 3 months.
Read more
On inclusion, after seeing the physician, an adapted physical activity teacher (EAPA) and a hospital dietician will assess the patient's physical capacities and dietary needs, in order to draw up an adapted physical and dietary program. The CRA will assess the patient's quality of life using a questionnaire. When the patient is discharged, he will be given a notebook in which to keep track of appointments with healthcare professionals (GP, private dietician, EAPA). Patients are also asked to keep a record of their non-protocol care appointments and participation in physical activities.
After hospitalization, the patient will have to follow a multi-professional program: dietetic by a private dietician (at D3-J5, at 3 weeks and then at 6 weeks), medical by the general practitioner (at 1 month), and adapted physical activity by the EAPA (during 3 months).
At three months, the patient will be seen again by the hospital's health professionals. The investigating physician will reassess nutritional status, and the EAPA will reassess physical capacity. The patient will be asked to return his diary so that data can be collected. They will also be given a quality of life and satisfaction questionnaire to complete.
When all patients have completed their follow-up, a satisfaction questionnaire will be sent to each healthcare professional.
Currently, as part of standard care, , dietetics and physical rehabilitation are not reimbursed. As a result, although recommended, patients rarely benefit from a dietetic consultation and adapted physical activity follow-up following a diagnosis of undernutrition. We therefore hypothesize that early cooperative outpatient care, involving general practitioners, private dieticians and adapted physical activity teachers (EAPA), for adult patients diagnosed as moderately or severely malnourished during hospitalization will optimize the management of these patients.
- Conditions
- Malnutrition Severe, Malnutrition; Moderate
- Being tested
- Dietary and physical activity monitoring during the 3-months post-hospitalization period
- Keywords
- moderate malnutrition, severe malnutrition, ambulatory care, discharge from hospital
- Medical subject headings
- Malnutrition, Lymphoma, Follicular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dietary and physical activity monitoring during the 3-months post-hospitalization periodOther
Three consultations with a private dietician, one consultation with the general practitioner, three months of APA monitoring
| Study group | Role | What they receive |
|---|---|---|
| After-hospital, care by a private dietician and a physical activity teacher | Experimental | For this study, there is only one arm. After hospital discharge, the patient will have multi-professional monitoring of his undernutrition: private dietician, adapted physical activity teacher and general practitioner. Receives: Other: Dietary and physical activity monitoring during the 3-months post-hospitalization period |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate patient compliance with a new management program (dietetics and physical rehabilitation) for undernutrition on discharge from hospital
Assessment of patient compliance with the innovative program will be based on their participation in the various consultations under the protocol (medical, dietary, physical rehabilitation), as well as in their adapted physical activity program. The clinical research associate in charge of the study will collect these data from the data transmitted by the professionals in charge of the patient's follow-up (physician, dietician, EAPA), as well as from the follow-up booklet completed by the patient.
Adherence will be measured by analyzing deviations from consultations and APA sessions scheduled as part of the protocol, by category:
- Medical: 2 scheduled consultations (attending general practitioner + hospital physician)
- Dietetics: 3 consultations planned
- Adapted physical activity: number of sessions varies according to the program defined by the EAPA
Measured: Only once, at the 3 months follow-up
Secondary outcomes (14)
Evaluate the patient's grip strength during the study
Grip strength will be assessed using the handgrip, enabling muscle strength to be measured in kg. The grip strength test will be performed according to the Southampton protocol.
Measured: Three times : At inclusion, at 1 month and 3 months after inclusion
Evaluate the speed of chair lifting during the study
Chair-lifting speed is assessed by the 5 chair-lifts test. This is a benchmark test for assessing muscle strength.
Measured: Three times : At inclusion, at 1 month and 3 months after inclusion
Evaluate the walking speed during the study
Walking speed is assessed by the 4-meter walking test (4MWT). Walking speed over 4 meters is assessed to the nearest 0.01 second using a stopwatch. The test will be carried out twice in succession, and the fastest walking speed, expressed in m/s, will be used.
Measured: Three times : At inclusion, at 1 month and 3 months after inclusion
Evaluate the patient's weight during the study
Weight will be measured in kilograms. Weight measurements at D0 and M3 will be taken on the same model of scale. As weight measurement at M1 is carried out at the attending physician's, the scale used will be different from that used for the other two measurement points.
Measured: Three times : At inclusion, at 1 month and 3 months after inclusion
Evaluate the patient's nutrition status during the study
The status of "undernourished" / "not undernourished" will be determined on the basis of the definition given in the latest HAS recommendations (Diagnosis of undernutrition in children and adults - November 2019 and Diagnosis of undernutrition in people aged 70 and over - November 2021).
Measured: Twice : At inclusion and at 3 months after inclusion
Evaluate the patient's biological parameters during the study : phosphorus, magnesium, potassium, calcemia, corrected calcemia and transferrin-binding capacity
The results of these biological parameters prescribed as standard for monitoring undernutrition will be recorded during the three medical visits, if values are available. The unit of measurement for these blood parameters will be the mmol/L.
Measured: Three times : At inclusion, at 1 month and 3 months after inclusion
Evaluate the patient's biological parameters relating to liver activity during the study : ASAT, ALAT, PAL, gamma-GT
The results of these biological parameters prescribed as standard for monitoring undernutrition will be recorded during the three medical visits, if values are available. The unit of measurement for these blood parameters will be the UI/L.
Measured: Three times : At inclusion, at 1 month and 3 months after inclusion
Evaluate the patient's biological parameters during the study : albumin, pre-albumin, CRP, ferritin
The results of these biological parameters prescribed as standard for monitoring undernutrition will be recorded during the three medical visits, if values are available. The unit of measurement for these blood parameters will be the g/L.
Measured: Three times : At inclusion, at 1 month and 3 months after inclusion
Evaluate the patient's quality of life during the study by the EQ-5D-5L questionnaire.
Patients' quality of life will be assessed using the EQ-5D-5L questionnaire at three medical visits. The EQ-5D-5L questionnaire consists of a descriptive section and a visual analog scale. The descriptive part comprises five dimensions: mobility, personal care, usual activities, pain/discomfort and anxiety/depression. Each dimension is rated by the patient according to 5 degrees: no problems, mild problems, moderate problems, severe problems and extreme problems. The visual scale is a vertical analog scale, with the ends labelled "the best health you can imagine" (score : 100) and "the worst health you can imagine" (score : 0). The difference in score between the baseline and the two follow-up visits will be measured.
Measured: Three times : At inclusion, at 1 month and 3 months after inclusion
Evaluate end-of-study re-hospitalization and mortality rates
The number of re-hospitalized and deceased patients will be collected by the CRA from the patient's medical file and after discussion with the healthcare professionals in charge of the patient's follow-up.
Measured: Only once, at the 3 months follow-up
Evaluate patient satisfaction with their care at the end of the study
It will be assessed using a 5-point satisfaction scale, from very dissatisfied to very satisfied.
Measured: Only once, at the 3 months follow-up
At the end of the study, assess patients' consumption of out-of-protocol care
The use of dietary consultations, out-of-protocol physical rehabilitation sessions and complementary general medical consultations will be recorded by the CRA using a follow-up booklet completed by the patient.
Measured: Only once, at the 3 months follow-up
Evaluate the satisfaction of each professional involved (doctor, dietician, EAPA) in this protocol
The satisfaction of each professional involved (doctor, dietician, EAPA) in this protocol for the early management of undernutrition will be assessed using a 5-point satisfaction scale, from very dissatisfied to very satisfied.
Measured: Only once, at the study completion
Evaluate the medico-economic relevance of this new pathway for the early management of undernutrition
A cost-utility analysis will be carried out from both a societal and a health insurance perspective, in order to measure the relevance of the allocative efficiency of expenditure at M3. Utility will be calculated in relation to quality of life as measured by the EQ-5D-5L. Costs will be calculated on the basis of the following data:
- For direct medical and non-medical costs: cost of medical treatment, cost of consultations, cost of complementary biological and radiological examinations, cost of medical transport and out-of-pocket expenses for patients;
- For indirect costs: daily benefits related to work stoppage;
- For intangible costs: psychological consequences of illness.
Measured: Only once, at the 3 months follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2025
- Study start15 May 2025 (estimated)
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Malnutrition SevereStudies 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
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 27 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre hospitalier Henri Mondor d'Aurillac
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06976827
- Sponsor's protocol ID
- RIPH2_VILANOVA_DENUTADOM
- Other IDs
- IDRCB : 2025-A00416-43
- Acronym
- DENUTADOM
- Status last verified
- May 2025
- First submitted
- 29 Apr 2025
- Last updated
- 16 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prise en Charge de la dénutrition en Sortie d'Hospitalisation Par Des diététiciennes et Des Enseignants en activité Physique adapté à Domicile : étude de faisabilité (DENUTADOM)
- ClinicalTrials.gov ID
- NCT06976827
- Acronym / sponsor ID
- DENUTADOM / RIPH2_VILANOVA_DENUTADOM
- Conditions
- Malnutrition Severe, Malnutrition; Moderate
- Keywords
- moderate malnutrition, severe malnutrition, ambulatory care, discharge from hospital
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 27 participants (estimated)
- Lead sponsor
- Centre hospitalier Henri Mondor d'AurillacUniversity, hospital or other
- Study start
- 15 May 2025 (estimated)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 16 May 2025 (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.
The DENUTADOM study is a single-center feasibility study. It is an interventional research project involving human subjects (RIPH2), which will lead to a change in the care and treatment of adult patients diagnosed as suffering from moderate to severe undernutrition during hospitalization. The aim of this study was to assess patient compliance with a new undernutrition management program (diet and physical activity) at discharge from hospital.
In this study, during hospitalization, patients may be included in the study if they meet the inclusion criteria. To this end, the physician will offer to participate in the study, and will provide the patient with an information document. If the patient agrees to take part, he or she will be included in the study after signing the consent form. Participation will last 3 months.
On inclusion, after seeing the physician, an adapted physical activity teacher (EAPA) and a hospital dietician will assess the patient's physical capacities and dietary needs, in order to draw up an adapted physical and dietary program. The CRA will assess the patient's quality of life using a questionnaire. When the patient is discharged, he will be given a notebook in which to keep track of appointments with healthcare professionals (GP, private dietician, EAPA). Patients are also asked to keep a record of their non-protocol care appointments and participation in physical activities.
After hospitalization, the patient will have to follow a multi-professional program: dietetic by a private dietician (at D3-J5, at 3 weeks and then at 6 weeks), medical by the general practitioner (at 1 month), and adapted physical activity by the EAPA (during 3 months).
At three months, the patient will be seen again by the hospital's health professionals. The investigating physician will reassess nutritional status, and the EAPA will reassess physical capacity. The patient will be asked to return his diary so that data can be collected. They will also be given a quality of life and satisfaction questionnaire to complete.
When all patients have completed their follow-up, a satisfaction questionnaire will be sent to each healthcare professional.
Currently, as part of standard care, , dietetics and physical rehabilitation are not reimbursed. As a result, although recommended, patients rarely benefit from a dietetic consultation and adapted physical activity follow-up following a diagnosis of undernutrition. We therefore hypothesize that early cooperative outpatient care, involving general practitioners, private dieticians and adapted physical activity teachers (EAPA), for adult patients diagnosed as moderately or severely malnourished during hospitalization will optimize the management of these patients.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| After-hospital, care by a private dietician and a physical activity teacher | Experimental | Other: Dietary and physical activity monitoring during the 3-months post-hospitalization periodFor this study, there is only one arm. After hospital discharge, the patient will have multi-professional monitoring of his undernutrition: private dietician, adapted physical activity teacher and general practitioner. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Moderately or severely malnourished adult patient according to HAS diagnostic criteria: At least one phenotypic criterion: weight loss (> 5% in 1 month, > 10% in 6 months or relative to pre-disease weight), BMI < 18.5 in < 70 years or BMI < 22 in ≥ 70 years, reduced muscle mass and/or function AND At least one etiological criterion: reduction in food intake > 50% for > 7 days or > 14 days regardless of reduction, reduced absorption, aggressive situation with hypercatabolism
- Patient with an attending physician wishing to participate in the study
- Patient wishing to be followed by a private dietician participating in the study
Key exclusion criteria (7 listed)
- Patients with cognitive disorders
- Patients with eating disorders
- Pregnant or breast-feeding patient
- Patient with an estimated life expectancy of less than 6 months (at investigator's discretion)
- Patient under legal protection
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 |
|---|---|---|
| Dietary and physical activity monitoring during the 3-months post-hospitalization periodThree consultations with a private dietician, one consultation with the general practitioner, three months of APA monitoring | Other | After-hospital, care by a private dietician and a physical activity teacher |
Primary outcome
Evaluate patient compliance with a new management program (dietetics and physical rehabilitation) for undernutrition on discharge from hospital
Time frame: Only once, at the 3 months follow-up
Assessment of patient compliance with the innovative program will be based on their participation in the various consultations under the protocol (medical, dietary, physical rehabilitation), as well as in their adapted physical activity program. The clinical research associate in charge of the study will collect these data from the data transmitted by the professionals in charge of the patient's follow-up (physician, dietician, EAPA), as well as from the follow-up booklet completed by the patient. Adherence will be measured by analyzing deviations from consultations and APA sessions scheduled as part of the protocol, by category: * Medical: 2 scheduled consultations (attending general practitioner + hospital physician) * Dietetics: 3 consultations planned * Adapted physical activity: number of sessions varies according to the program defined by the EAPA
14 secondary outcomes
Evaluate the patient's grip strength during the study
Time frame: Three times : At inclusion, at 1 month and 3 months after inclusion
Evaluate the speed of chair lifting during the study
Time frame: Three times : At inclusion, at 1 month and 3 months after inclusion
Evaluate the walking speed during the study
Time frame: Three times : At inclusion, at 1 month and 3 months after inclusion
Evaluate the patient's weight during the study
Time frame: Three times : At inclusion, at 1 month and 3 months after inclusion
Evaluate the patient's nutrition status during the study
Time frame: Twice : At inclusion and at 3 months after inclusion
Evaluate the patient's biological parameters during the study : phosphorus, magnesium, potassium, calcemia, corrected calcemia and transferrin-binding capacity
Time frame: Three times : At inclusion, at 1 month and 3 months after inclusion
Evaluate the patient's biological parameters relating to liver activity during the study : ASAT, ALAT, PAL, gamma-GT
Time frame: Three times : At inclusion, at 1 month and 3 months after inclusion
Evaluate the patient's biological parameters during the study : albumin, pre-albumin, CRP, ferritin
Time frame: Three times : At inclusion, at 1 month and 3 months after inclusion
Evaluate the patient's quality of life during the study by the EQ-5D-5L questionnaire.
Time frame: Three times : At inclusion, at 1 month and 3 months after inclusion
Evaluate end-of-study re-hospitalization and mortality rates
Time frame: Only once, at the 3 months follow-up
Evaluate patient satisfaction with their care at the end of the study
Time frame: Only once, at the 3 months follow-up
At the end of the study, assess patients' consumption of out-of-protocol care
Time frame: Only once, at the 3 months follow-up
Evaluate the satisfaction of each professional involved (doctor, dietician, EAPA) in this protocol
Time frame: Only once, at the study completion
Evaluate the medico-economic relevance of this new pathway for the early management of undernutrition
Time frame: Only once, at the 3 months follow-up
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 May 2025.
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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.
Centre hospitalier Henri Mondor d'Aurillac
Aurillac, France
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dietary and physical activity monitoring during the 3-months post-hospitalization period in people with Malnutrition Severe and Malnutrition; Moderate, run by Centre hospitalier Henri Mondor d'Aurillac at 1 site in France.
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 7 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: opening soon, as of the sponsor's last update on 16 May 2025. 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 France. 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluate patient compliance with a new management program (dietetics and physical rehabilitation) for undernutrition on discharge from hospital (time frame: Only once, at the 3 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 16 May 2025.