Under-nutrition or Risk of UndernutritionNUTRIACTIFNCT03979560
Clinical and Medico-economic Evaluation of Taken Care Associating Nutritional Support and Adapted Physical Activity for Malnourished, or at Risk of Undernutrition, Elderly People on Discharge From Hospital
A study testing Intervention in people with Under-nutrition or Risk of Undernutrition, run by Gérond'if at 1 site in France.
Trial summary
In the hospital, one out of every two elderly people is malnourished. This condition of undernutrition generally worsens during hospitalization, where the effects of polypathology and psychological distress are added. Read more about this study
- Who is it for?
- Ages 70 years and older
- Conditions the study is for
- Under-nutrition or Risk of Undernutrition
- What is being tested?
- Intervention
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 47 participants
- Where
- 1 siteFrance
- Study dates
- 28 Jun 2019to 23 Dec 2021
- 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 70 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Men or women aged at least 70
- Hospitalized in acute geriatrics (UGA), with expected return to home directly after the UGA
- Undernourished or at risk of undernutrition (MNA SF12)
- Able to walk 4 metres without third party assistance
- Able to understand and consent to the study
- Good understanding of the French language
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- Living in Paris (department 75)
- Patient affiliated with a social security scheme
- Having read the information note and having agreed to participate in the study by signing the consent.
Who cannot join
- Life expectancy less than 6 months
- Chronic inflammatory pathology
- Progressive cancer
- Severe renal failure (creatinine clearance < 30ml/min/1.73 m2)
- NYHA Stage III or IV Dyspnea
- Chronic respiratory failure (oxygen therapy at home)
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- Liver failure (TP < 50%)
- Severe depression
- severe dementia, according to DSM V criteria
- swallowing disorders with inhalation pneumonia
- corticosteroids (> 10 mg prednisone/day long-term or equivalent)
- Systolic blood pressure >200 mmHg
- Unstabilized acute coronary syndrome
- decompensated heart failure
- Severe, uncontrolled ventricular rhythm disorders
- High risk embolic intracardiac thrombus
- Presence of medium to large pericardial effusion
- Recent history of thrombophlebitis with or without pulmonary embolism
- Obstacle to severe and/or symptomatic left ventricular ejection
- Severe and symptomatic pulmonary hypertension
- Inability to perform appropriate physical activities
- Subject participating or having participated in a therapeutic trial within the last 3 months
- Refusal to participate
- Person under guardianship, guardianship or safeguard of justice
Trial locations and contacts
1 site in 1 country.
France1 site
Département de Gériatrie, Hôpital Bichat
Paris, Île-de-France Region, 75018
About this study
In the hospital, one out of every two elderly people is malnourished. This condition of undernutrition generally worsens during hospitalization, where the effects of polypathology and psychological distress are added. Muscle loss due to inadequate dietary intake, hypermetabolism and immobilization results in the onset or worsening of mobility disorders and functional decline. After hospitalization, 30-50% of elderly people hospitalized in emergency in medical departments have lost autonomy in daily life. Nutritional management and adaptive physical activity (APA) could have synergistic action to improve the nutritional status and mobility of elderly patients. The short duration of the average stay the acute geriatric units (10-15 days) is not enough to renew, nor to re-educate patients. It seems important to continue these actions at home. The implementation of programs combining nutrition and adapted physical activity (APA) at the hospital exit has not been studied to date. We formulate the hypothesis that in elderly people who are malnourished or at risk of undernutrition, after hospitalization, a personalized home intervention combining nutritional advice and appropriate physical activity will limit their loss of autonomy.
Read the detailed description
Interventional study with minimal risk and constraints, prospective, multicentre, randomised and controlled.
Population of interest:
- Older people at least 70 years, malnourished or at risk of malnutrition, on discharge from hospital
- Informal caregivers of patients included in study
Intervention at home of professionals:
Mixed intervention: nutritional support, carried out by the dieticians of " Saveurs et Vie ", in seven sessions over three months, combined with an adapted physical activity intervention (APA), carried out by " Siel Bleu " professionals, also at a frequency of seven sessions over three months, for a total of fourteen sessions.
Control arm will benefit from usual support (depending on practices of the department, prescription or not of oral nutritional supplements and physiotherapy at home, but without home intervention of adapted physical activity professionals or dieticians).
In addition to screening/inclusion visits (D0), three follow-up home visits are scheduled at D7, D45 and D90 for both study groups.
Inclusion visit (D0), performed in hospital in geriatric ward prior to hospital discharge. Verification of inclusion criteria, collection of consent by investigator, randomization, collection of inclusion data (socio-educational level, family status, assessment of autonomy (ADL, IADL, AGGIR) number of drugs, comorbidity (CIRS-G), cognitive status, biology performed during hospitalization (albumin, CRP, Vitamin D) and discharge prescription (NOC, nutritional advice, physiotherapy) are programmed to D7, D45 and D90 for both study arms.
Follow-up visits to D7, D45 and D90, carried out at home by a clinal research technician mandated by sponsor (Gérond'if). Assessment of autonomy (ADL, IADL, AGGIR scale), nutritional status (weight, height, self-evaluation of appetite, MNA), functional status (Grinding strength, 4-metre walking speed, SPPB), quality of life (EQ-5D), frequency and transit time of home help workers, whether family or professional. Acceptability of interventions for the home intervention arm.
2 patient/arms, a total of 372 patients divided as follows:
- Interventional arm : Nutrition intervention with appropriate physical activity for 186 patients
- Control arm: standard care for 186 other patients And up to 160 informal caregivers (family members) in both groups, or 80 caregivers per group (one caregiver per patient).
Inclusion period: 15 months. Follow-up period: 3 months/subject (patients and caregivers) Total length of study: 18 months
- Being tested
- Intervention
- Keywords
- Autonomy, Nutritional support, Adapted physical activity, Undernutrition, Older people, Hospital discharge, Under-nutrition
- Medical subject headings
- Malnutrition
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
InterventionOther
Nutritional support in seven sessions spread over three months, combined with an adapted physical activity intervention (APA), also at a frequency of seven sessions spread over three months, or fourteen home sessions.
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | The control group will benefit from the usual support (depending on the practices of the department, prescription or not of oral nutritional supplements and physiotherapy at home, but without home intervention of adapted physical activity professionals or dieticians). In addition to screening/inclusion visits (D0), three follow-up home visits are scheduled at D7, D45 and D90 for both study groups. |
| Nutrition intervention with appropriate physical activity | Experimental | Intervention at home of professionals:
Patients in this arm will benefit from 14 home interventions
* 7 home nutrition support (NS) sessions in 3 months or 1 session every 10 days (+/-4 days). These sessions will be conducted by a dietician from the company "Saveurs et Vie".
* 7 home sessions of adaptive physical activity (APA) in 3 months, one session every 10 days (+/-4 days). These sessions will be conducted by professionals from association group "Siel Bleu".
In addition to screening/inclusion visits (D0), three follow-up home visits are scheduled at D7, D45 and D90 for both study groups. Receives: Other: Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of level of autonomy according Activities of Daily Living (ADL) score
To assess the effect of taken care associating nutritional support and adapted physical activity (APA) on the independence of elderly people who are malnourished or at risk of malnutrition at the end of their stay in hospital.
Measured: 18 months
Secondary outcomes (6)
Assessment of of dependency according Gerontological autonomy group iso-resources (AGGIR ) score
Measured: 18 mois
Assessment of undernutrition according Mini Nutritional Assessment (MNA)
Measured: 18 months
Assessment of gait, balance and muscle according Short Physical Performance Battery (SPPB) score
Measured: 18 months
Measuring quality of life according EuroQol- 5 Dimension (EQ-5D) scale
Measured: 18 months
Assessment of comorbidity according Cumulative Illness Rating Scale-Geriatric (CIRS-G) scale
Measured: 18 months
Assessment caregiver burden according Caregiver Subjective and Objective Burden (Zarit) scale
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2019
- Study start28 Jun 2019
- Primary completion17 Jun 2021
- Study completion23 Dec 2021
Why it stopped: Lack of inclusion of patients
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Under-nutrition or Risk of UndernutritionStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 47 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gérond'if
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03979560
- Sponsor's protocol ID
- 2017-A02973-50
- Acronym
- NUTRIACTIF
- Status last verified
- Jan 2023
- First submitted
- 9 May 2019
- Last updated
- 2 Feb 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical and Medico-economic Evaluation of Taken Care Associating Nutritional Support and Adapted Physical Activity for Malnourished, or at Risk of Undernutrition, Elderly People on Discharge From Hospital
- ClinicalTrials.gov ID
- NCT03979560
- Acronym / sponsor ID
- NUTRIACTIF / 2017-A02973-50
- Keywords
- Autonomy, Nutritional support, Adapted physical activity, Undernutrition, Older people, Hospital discharge, Under-nutrition
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Lack of inclusion of patients
- Enrolment
- 47 participants (actual)
- Lead sponsor
- Gérond'ifUniversity, hospital or other
- Study start
- 28 Jun 2019 (actual)
- Primary completion
- 17 Jun 2021 (actual)
- Study completion
- 23 Dec 2021 (actual)
- First posted
- 7 Jun 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.
In the hospital, one out of every two elderly people is malnourished. This condition of undernutrition generally worsens during hospitalization, where the effects of polypathology and psychological distress are added. Muscle loss due to inadequate dietary intake, hypermetabolism and immobilization results in the onset or worsening of mobility disorders and functional decline. After hospitalization, 30-50% of elderly people hospitalized in emergency in medical departments have lost autonomy in daily life. Nutritional management and adaptive physical activity (APA) could have synergistic action to improve the nutritional status and mobility of elderly patients. The short duration of the average stay the acute geriatric units (10-15 days) is not enough to renew, nor to re-educate patients. It seems important to continue these actions at home. The implementation of programs combining nutrition and adapted physical activity (APA) at the hospital exit has not been studied to date. We formulate the hypothesis that in elderly people who are malnourished or at risk of undernutrition, after hospitalization, a personalized home intervention combining nutritional advice and appropriate physical activity will limit their loss of autonomy.
Detailed description
Interventional study with minimal risk and constraints, prospective, multicentre, randomised and controlled.
Population of interest:
- Older people at least 70 years, malnourished or at risk of malnutrition, on discharge from hospital
- Informal caregivers of patients included in study
Intervention at home of professionals:
Mixed intervention: nutritional support, carried out by the dieticians of " Saveurs et Vie ", in seven sessions over three months, combined with an adapted physical activity intervention (APA), carried out by " Siel Bleu " professionals, also at a frequency of seven sessions over three months, for a total of fourteen sessions.
Control arm will benefit from usual support (depending on practices of the department, prescription or not of oral nutritional supplements and physiotherapy at home, but without home intervention of adapted physical activity professionals or dieticians).
In addition to screening/inclusion visits (D0), three follow-up home visits are scheduled at D7, D45 and D90 for both study groups.
Inclusion visit (D0), performed in hospital in geriatric ward prior to hospital discharge. Verification of inclusion criteria, collection of consent by investigator, randomization, collection of inclusion data (socio-educational level, family status, assessment of autonomy (ADL, IADL, AGGIR) number of drugs, comorbidity (CIRS-G), cognitive status, biology performed during hospitalization (albumin, CRP, Vitamin D) and discharge prescription (NOC, nutritional advice, physiotherapy) are programmed to D7, D45 and D90 for both study arms.
Follow-up visits to D7, D45 and D90, carried out at home by a clinal research technician mandated by sponsor (Gérond'if). Assessment of autonomy (ADL, IADL, AGGIR scale), nutritional status (weight, height, self-evaluation of appetite, MNA), functional status (Grinding strength, 4-metre walking speed, SPPB), quality of life (EQ-5D), frequency and transit time of home help workers, whether family or professional. Acceptability of interventions for the home intervention arm.
2 patient/arms, a total of 372 patients divided as follows:
- Interventional arm : Nutrition intervention with appropriate physical activity for 186 patients
- Control arm: standard care for 186 other patients And up to 160 informal caregivers (family members) in both groups, or 80 caregivers per group (one caregiver per patient).
Inclusion period: 15 months. Follow-up period: 3 months/subject (patients and caregivers) Total length of study: 18 months
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –The control group will benefit from the usual support (depending on the practices of the department, prescription or not of oral nutritional supplements and physiotherapy at home, but without home intervention of adapted physical activity professionals or dieticians). In addition to screening/inclusion visits (D0), three follow-up home visits are scheduled at D7, D45 and D90 for both study groups. |
| Nutrition intervention with appropriate physical activity | Experimental | Other: InterventionIntervention at home of professionals: Patients in this arm will benefit from 14 home interventions * 7 home nutrition support (NS) sessions in 3 months or 1 session every 10 days (+/-4 days). These sessions will be conducted by a dietician from the company "Saveurs et Vie". * 7 home sessions of adaptive physical activity (APA) in 3 months, one session every 10 days (+/-4 days). These sessions will be conducted by professionals from association group "Siel Bleu". In addition to screening/inclusion visits (D0), three follow-up home visits are scheduled at D7, D45 and D90 for both study groups. |
Who may qualify
- Ages
- 70 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (9 listed)
- Men or women aged at least 70
- Hospitalized in acute geriatrics (UGA), with expected return to home directly after the UGA
- Undernourished or at risk of undernutrition (MNA SF12)
- Able to walk 4 metres without third party assistance
- Able to understand and consent to the study
Key exclusion criteria (24 listed)
- Life expectancy less than 6 months
- Chronic inflammatory pathology
- Progressive cancer
- Severe renal failure (creatinine clearance < 30ml/min/1.73 m2)
- NYHA Stage III or IV Dyspnea
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 |
|---|---|---|
| InterventionNutritional support in seven sessions spread over three months, combined with an adapted physical activity intervention (APA), also at a frequency of seven sessions spread over three months, or fourteen home sessions. | Other | Nutrition intervention with appropriate physical activity |
Primary outcome
Assessment of level of autonomy according Activities of Daily Living (ADL) score
Time frame: 18 months
To assess the effect of taken care associating nutritional support and adapted physical activity (APA) on the independence of elderly people who are malnourished or at risk of malnutrition at the end of their stay in hospital.
6 secondary outcomes
Assessment of of dependency according Gerontological autonomy group iso-resources (AGGIR ) score
Time frame: 18 mois
Assessment of undernutrition according Mini Nutritional Assessment (MNA)
Time frame: 18 months
Assessment of gait, balance and muscle according Short Physical Performance Battery (SPPB) score
Time frame: 18 months
Measuring quality of life according EuroQol- 5 Dimension (EQ-5D) scale
Time frame: 18 months
Assessment of comorbidity according Cumulative Illness Rating Scale-Geriatric (CIRS-G) scale
Time frame: 18 months
Assessment caregiver burden according Caregiver Subjective and Objective Burden (Zarit) scale
Time frame: 18 months
Results and safety
The study was stopped early (reason given: Lack of inclusion of patients). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Feb 2023.
- Individual participant dataSharing planned: Undecided
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intervention in people with Under-nutrition or Risk of Undernutrition, 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 9 inclusion and 24 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: stopped early, as of the sponsor's last update on 2 Feb 2023. 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 was stopped early (reason given: Lack of inclusion of patients). Results are not available in the source record.
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?
Assessment of level of autonomy according Activities of Daily Living (ADL) score (time frame: 18 months). 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 2 Feb 2023.