Undernutrition of Elderly PeopoleDIETADOMNCT04016532
Personalized Dietary Advice After Discharge From Hospital in Geriatrics: Factors Associated With Improved Nutritional Status and Autonomy
A study testing Personalized dietary management at home in people with Undernutrition of Elderly Peopole, run by Gérond'if at 1 site in France.
Trial summary
The purpose of this study is to identify the factors associated with the effectiveness of home dietary management in these elderly people returning home (personal home or independent residence) after hospitalization in acute geriatrics. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Undernutrition of Elderly Peopole
- What is being tested?
- Personalized dietary management at home
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 353 participants
- Where
- 1 siteFrance
- Study dates
- 25 Jun 2019to 30 Nov 2023
- 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 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Unscheduled hospitalization of at least 4 days in acute geriatrics,
- Direct return to home or independent residence after hospitalization,
- To be domiciled in the Hauts-de-Seine department,
- Good understanding of the French language,
- Beneficiary of a social security scheme,
- Having read the briefing note and having consented to participate in the study by signing a written consent,
Who cannot join
- Severe cognitive impairment according to DMS-IV criteria,
- Inflammatory syndrome (CRP > 30 mg/l)
- Evolving cancer;
- Chronic respiratory failure,
- Stage IV heart failure
- long-term corticosteroids (> 10 mg/d prednisolone or equivalent),
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- Enteral and parenteral nutrition at home,
- Chronic end-stage pathology;
- Inability to walk without human help
- Major person subject to a legal protection measure (guardianship, guardianship and safeguarding of justice)
Trial locations and contacts
1 site in 1 country.
France1 site
Geriactric Departement, Rives de Seine hopsital
Courbevoie, Île-de-France Region, 92400
About this study
The purpose of this study is to identify the factors associated with the effectiveness of home dietary management in these elderly people returning home (personal home or independent residence) after hospitalization in acute geriatrics.
Read the detailed description
Patient recruitment will be carried out in the 6 participating hospital centres.
All patients willing to participate, will benefit from an Inclusion Visit (J0): Conducted in hospital in acute geriatric services before discharge from hospital. Verification of inclusion criteria, collection of patient consent by investigator, assignment of patient identification number, declaration of inclusion, and collection by investigator of inclusion data (age, sex, weight, height, appetite, dietary intake scale, risk factors for undernutrition by HAS, albumin, CRP, exit treatment, ADL, IADL and GIR, technical aids for walking, presence of professional and non-professional home workers).
Home visit J7 (30 min to 1 hour): initial dietary assessment, will be carried out between 24 hours and 7 days after discharge from hospital. During this visit, the dietician will perform several measurements (MNA-SF, weight, height, appetite assessment, ingest/24h Consumption of NOCs if prescribed in hospital, Quality of Life, ADL, IADL, acceptance of visit, follow-up of dietary advice and intercurrent medical events).
Home visit J30, J60 (30 min to 1h): Made by the dietician, during these visits will be carried out various measurements and questionnaires: Appetite assessment, weight, ingesta/24h, consumption of NOCs, acceptance of the visit, follow up on dietary advice, compendiums of intercurrent medical events.
Home visit J90 = Final visit. This visit is identical to the initial assessment (J7). Patients who are undernourished or at risk of undernutrition will receive an additional J15 home visit (15 days after discharge from hospital). This visit will be identical to visits J30, J60.
- Conditions
- Undernutrition of Elderly Peopole
- Being tested
- Personalized dietary management at home
- Keywords
- Elderly peopole, Undernutrition, Acute Geriatric
- Medical subject headings
- Malnutrition
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Personalized dietary management at homeDietary supplement
Personalized dietary management at home to improve nutritional status.
- Four (J7, J30, J60 and J90 for non-undernutrition patients) or five Home visits (J7, J15, J30 and J90 for undernutrition patients or at risk of undernutrition) by professional dietitians from Saveurs \& Vie over a period of 3 months after discharge from the hospital: personalized dietary advice and recipe sheet.
- There will be no change in medical prescriptions
| Study group | Role | What they receive |
|---|---|---|
| Patient malnourished or at risk of undernutrition | Other | Dietary follow-up at home: 4 visits (D15, D30, D60, D90) Receives: Dietary Supplement: Personalized dietary management at home |
| Not undernourished patients | Other | Dietary follow-up at home: 3 visits ( D30,D60, D90) Receives: Dietary Supplement: Personalized dietary management at home |
What is being measured
The primary outcome is the main question the study is designed to answer.
Screening for undernutrition in geriatric practice according the MNA-SF score (Short-Form Mini-Nutritional Assessment)
Measured: 3 months
Secondary outcomes (5)
Assessment of the appetite according the VAS scale "Visual Analog Scale"
Measured: 3 months
Assessment of teh degree of autonomy according AGGIR score
Measured: Inclusion (0 day)
Assessment of patient's level of dependence through an appreciation of instrumental activities of daily living according Lawton scale
Measured: 3 months
Assessment of the degree of patient dependence according "Index of Independence in Activities of Daily Living" KATZ scale
Measured: 3 months
Grab force measurement according the dynamometer
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2019
- Study start25 Jun 2019
- Primary completion30 Nov 2023
- Study completion30 Nov 2023
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 Undernutrition of Elderly PeopoleStudies 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
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 353 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gérond'if
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Christine CHANSIAUX, MD, Study chair, Geriatric Departement, Rives de Seine hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04016532
- Sponsor's protocol ID
- 2018-A03458-47
- Acronym
- DIETADOM
- Status last verified
- Sep 2026
- First submitted
- 3 Jul 2019
- Last updated
- 21 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Sanchez M, Courtois-Amiot P, Gotze K, Lazzari S, Roux S, Jallot B, Paris E, Chansiaux-Buccalo C, Raynaud-Simon A. A community programme of home visits by dieticians after discharge from geriatric acute care wards: baseline characteristics according to weight change during follow-up. BMC Geriatr. 2026 Mar 18;26(1):587. doi: 10.1186/s12877-026-07242-y.
PubMed 41851837
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Personalized Dietary Advice After Discharge From Hospital in Geriatrics: Factors Associated With Improved Nutritional Status and Autonomy
- ClinicalTrials.gov ID
- NCT04016532
- Acronym / sponsor ID
- DIETADOM / 2018-A03458-47
- Conditions
- Undernutrition of Elderly Peopole
- Keywords
- Elderly peopole, Undernutrition, Acute Geriatric
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 353 participants (actual)
- Lead sponsor
- Gérond'ifUniversity, hospital or other
- Study start
- 25 Jun 2019 (actual)
- Primary completion
- 30 Nov 2023 (actual)
- Study completion
- 30 Nov 2023 (actual)
- First posted
- 11 Jul 2019 (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 purpose of this study is to identify the factors associated with the effectiveness of home dietary management in these elderly people returning home (personal home or independent residence) after hospitalization in acute geriatrics.
Detailed description
Patient recruitment will be carried out in the 6 participating hospital centres.
All patients willing to participate, will benefit from an Inclusion Visit (J0): Conducted in hospital in acute geriatric services before discharge from hospital. Verification of inclusion criteria, collection of patient consent by investigator, assignment of patient identification number, declaration of inclusion, and collection by investigator of inclusion data (age, sex, weight, height, appetite, dietary intake scale, risk factors for undernutrition by HAS, albumin, CRP, exit treatment, ADL, IADL and GIR, technical aids for walking, presence of professional and non-professional home workers).
Home visit J7 (30 min to 1 hour): initial dietary assessment, will be carried out between 24 hours and 7 days after discharge from hospital. During this visit, the dietician will perform several measurements (MNA-SF, weight, height, appetite assessment, ingest/24h Consumption of NOCs if prescribed in hospital, Quality of Life, ADL, IADL, acceptance of visit, follow-up of dietary advice and intercurrent medical events).
Home visit J30, J60 (30 min to 1h): Made by the dietician, during these visits will be carried out various measurements and questionnaires: Appetite assessment, weight, ingesta/24h, consumption of NOCs, acceptance of the visit, follow up on dietary advice, compendiums of intercurrent medical events.
Home visit J90 = Final visit. This visit is identical to the initial assessment (J7). Patients who are undernourished or at risk of undernutrition will receive an additional J15 home visit (15 days after discharge from hospital). This visit will be identical to visits J30, J60.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patient malnourished or at risk of undernutrition | Other | Dietary Supplement: Personalized dietary management at homeDietary follow-up at home: 4 visits (D15, D30, D60, D90) |
| Not undernourished patients | Other | Dietary Supplement: Personalized dietary management at homeDietary follow-up at home: 3 visits ( D30,D60, D90) |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Unscheduled hospitalization of at least 4 days in acute geriatrics,
- Direct return to home or independent residence after hospitalization,
- To be domiciled in the Hauts-de-Seine department,
- Good understanding of the French language,
- Beneficiary of a social security scheme,
Key exclusion criteria (10 listed)
- Severe cognitive impairment according to DMS-IV criteria,
- Inflammatory syndrome (CRP > 30 mg/l)
- Evolving cancer;
- Chronic respiratory failure,
- Stage IV heart failure
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 |
|---|---|---|
| Personalized dietary management at homePersonalized dietary management at home to improve nutritional status. * Four (J7, J30, J60 and J90 for non-undernutrition patients) or five Home visits (J7, J15, J30 and J90 for undernutrition patients or at risk of undernutrition) by professional dietitians from Saveurs \& Vie over a period of 3 months after discharge from the hospital: personalized dietary advice and recipe sheet. * There will be no change in medical prescriptions | Dietary supplement | Not undernourished patients, Patient malnourished or at risk of undernutrition |
Primary outcome
Screening for undernutrition in geriatric practice according the MNA-SF score (Short-Form Mini-Nutritional Assessment)
Time frame: 3 months
5 secondary outcomes
Assessment of the appetite according the VAS scale "Visual Analog Scale"
Time frame: 3 months
Assessment of teh degree of autonomy according AGGIR score
Time frame: Inclusion (0 day)
Assessment of patient's level of dependence through an appreciation of instrumental activities of daily living according Lawton scale
Time frame: 3 months
Assessment of the degree of patient dependence according "Index of Independence in Activities of Daily Living" KATZ scale
Time frame: 3 months
Grab force measurement according the dynamometer
Time frame: 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 21 Sep 2026.
- Derived from this study: PubMed 41851837Sanchez M, Courtois-Amiot P, Gotze K, Lazzari S, Roux S, Jallot B, Paris E, Chansiaux-Buccalo C, Raynaud-Simon A. A community programme of home visits by dieticians after discharge from geriatric acute care wards: baseline characteristics according to weight change during follow-up. BMC Geriatr. 2026 Mar 18;26(1):587. doi: 10.1186/s12877-026-07242-y.
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.
Christine CHANSIAUX, MD study chair
Geriatric Departement, Rives de Seine hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Personalized dietary management at home in people with Undernutrition of Elderly Peopole, run by Gérond'if 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 6 inclusion and 10 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 21 Sep 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 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?
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?
Screening for undernutrition in geriatric practice according the MNA-SF score (Short-Form Mini-Nutritional Assessment) (time frame: 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 NCT04016532, 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 21 Sep 2026.