UndernutritionPLAIDNCT05389098
Finger Food, Pleasure at Your Fingertips: Randomized Pilot Study, Open-label and Parallel Groups
A study testing Hand-Eating in people with Undernutrition and Elderly Person, run by University Hospital, Tours at 2 sites in France.
Trial summary
Food is available in easy-to-grip bites that allow residents in care settings to use their fingers for food. This new way of eating can help limit weight loss, increase food intake, gain independence and improve the enjoyment of eating for residents. Read more about this study
- Who is it for?
- Ages 75 to 120 yearsHealthy volunteers can take part
- Conditions the study is for
- Undernutrition, Elderly Person
- What is being tested?
- Hand-Eating
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 2 sitesFrance
- Study dates
- 3 Aug 2023to 31 Jan 2027
- 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 75 to 120 years
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- Male or female residents over 75 years old living in a Accommodation facility for dependent elderly people for at least 3 months
- Presenting at least one of the following 3 criteria:
- Unintentional weight loss ≥ 5% in 1 month
- Involuntary weight loss ≥ 10% in 6 months or compared to the usual weight or compared to the weight at entry to the EHPAD
- Confirmed sarcopenia:
- Male (at least one of the 2 criteria):
Show all 14Show fewer
- Dynamometer (kg): < 27 AND calf circumference (cm): < 31
- Impedancemetry: appendicular muscle mass index < 20 kg OR appendicular muscle mass index < 7 kg/m²
- Woman (at least one of the 2 criteria):
- Dynamometer (kg): < 16 AND calf circumference (cm): < 31
- Impedancemetry: appendicular muscle mass index < 15 kg OR appendicular muscle mass index < 5.5 kg/m²
- Loss of autonomy according to the Tully scale < 12/18 with a score of 2 or 3 on the item "Able to bite, chew, swallow without making false routes"
- Person having given free, informed and express consent
- Person having an affiliation to a social security scheme
Who cannot join
- Protected person: safeguard of justice
- Swallowing disorder having a contra-indication to the texture of hand-eating meals.
- Lack of motor skills in both hands
- Specific diet: pleasure diet, salt-free, sugar-free, fiber-free, artificial nutrition
- Wearer of a pacemaker
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
France2 sites, 2 recruiting
- Not yet recruiting
EHPAD " Val de Brenne " Site : Auzouer en Touraine
Château-Renault, 37110
Aïssata SABO SAIDOU, MD, 06 71 39 79 32, a.sabosaidou@chicacr.fr
06 71 39 79 32
- Recruiting
EHPAD L'ERMITAGE-CHU de TOURS
Tours, 37100
Laura COUTON, +33247478568, L.COUTON@chu-tours.fr
Wiebe de JONG, MSc, +33247474680, w.dejong@chu-tours.fr
About this study
Official title: L'Alimentation Manger-mains, le Plaisir au Bout Des Doigts : Etude Pilote randomisée, en Ouvert et en Groupes parallèles
Food is available in easy-to-grip bites that allow residents in care settings to use their fingers for food. This new way of eating can help limit weight loss, increase food intake, gain independence and improve the enjoyment of eating for residents.
Read the detailed description
According to the Haute Autorité de Santé (HAS), undernutrition affects between 15 and 38% of elderly people living in institutions and between 50 and 60% of hospitalized elderly people. In addition, a significant decrease in satisfaction with meals was observed with increasing level of dependence.
The objective of the study is to evaluate the feasibility of implementing the finger food in care settings that could have a positive impact on the nutritional status of elderly people living in EHPAD.
- Conditions
- Undernutrition, Elderly Person
- Being tested
- Hand-Eating, Control
- Keywords
- Undernutrition, Elderly Person, Nursing home, Nutrition
- Medical subject headings
- Malnutrition
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hand-EatingOther
Also called EXPERIMENTAL
eat-hands type food mode
ControlOther
Also called Control group
Usual eating mode
| Study group | Role | What they receive |
|---|---|---|
| Experimental | Experimental | eat-hands type food mode Receives: Other: Hand-Eating |
| Control | Active comparator | Usual food administration Receives: Other: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Audit & Questionnaire of feasibility
Feasibility of implementing finger food for elderly patients in care settings will be evaluate with audit and questionnaire for caregivers by a dietician independent of the study.
Measured: After 3 patients included and at the end of study (6 months)
Secondary outcomes (5)
Weight
Weight in kilograms
Measured: Every two weeks during 6 months
Food consumption
Each week, a semi-quantitative evaluation of food intake will be performed for 3 days on a specific form (validated by the Francophone Society of Clinical and Metabolic Nutrition ). Every month, dietician will analyze these forms.
Measured: Each week during 6 months
Autonomy (EBS)
Autonomy for food intake will be assessed by the Eating Behavior Scale - EBS (Tully MW, Matrakas KL, Muir J, Musallam K. The Eating Behavior Scale. A simple method of assessing functional ability in patients with Alzheimer's disease. J Gerontol Nurs. 1997 Jul;23(7):9-15; quiz 54-5. doi: 10.3928/0098-9134-19970701-08. PMID: 9287601) by a dietetician.
The scores on this scale range from 0 to 18 : 18 is the best score, which means that the person is completely independent in eating.
Measured: Every month during 6 months
Eating pleasure
An evaluation of the pleasure of eating will be carried out once a month by the dietician via an hedonic scale with 3 face symbols: smiling face - neutral face - disappointed face.
Measured: Every month during 6 months
False routes
The occurrence of false routes will be collected throughout the study.
Measured: Every week during 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2022
- Study start3 Aug 2023
- Primary completion31 Jan 2027 (estimated)
- Study completion31 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized Pilot Study, Open-label and Parallel Groups
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Tours
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Laura COUTON, Study director, CHU ToursLaura COUTON, Principal investigator, CHU Tours
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05389098
- Sponsor's protocol ID
- DR200176-PLAID
- Other IDs
- ID-RCB
- Acronym
- PLAID
- Status last verified
- Nov 2025
- First submitted
- 16 May 2022
- Last updated
- 24 Nov 2025
- 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 24 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- L'Alimentation Manger-mains, le Plaisir au Bout Des Doigts : Etude Pilote randomisée, en Ouvert et en Groupes parallèles
- ClinicalTrials.gov ID
- NCT05389098
- Acronym / sponsor ID
- PLAID / DR200176-PLAID
- Conditions
- Undernutrition, Elderly Person
- Keywords
- Undernutrition, Elderly Person, Nursing home, Nutrition
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University Hospital, ToursUniversity, hospital or other
- Study start
- 3 Aug 2023 (actual)
- Primary completion
- 31 Jan 2027 (estimated)
- Study completion
- 31 Jan 2027 (estimated)
- First posted
- 24 May 2022 (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.
Food is available in easy-to-grip bites that allow residents in care settings to use their fingers for food. This new way of eating can help limit weight loss, increase food intake, gain independence and improve the enjoyment of eating for residents.
Detailed description
According to the Haute Autorité de Santé (HAS), undernutrition affects between 15 and 38% of elderly people living in institutions and between 50 and 60% of hospitalized elderly people. In addition, a significant decrease in satisfaction with meals was observed with increasing level of dependence.
The objective of the study is to evaluate the feasibility of implementing the finger food in care settings that could have a positive impact on the nutritional status of elderly people living in EHPAD.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomized Pilot Study, Open-label and Parallel Groups
| Arm | Type | Receives |
|---|---|---|
| Experimental | Experimental | Other: Hand-Eatingeat-hands type food mode |
| Control | Active comparator | Other: ControlUsual food administration |
Who may qualify
- Ages
- 75 to 120 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (14 listed)
- Male or female residents over 75 years old living in a Accommodation facility for dependent elderly people for at least 3 months
- Presenting at least one of the following 3 criteria:
- Loss of autonomy according to the Tully scale < 12/18 with a score of 2 or 3 on the item "Able to bite, chew, swallow without making false routes"
- Person having given free, informed and express consent
- Person having an affiliation to a social security scheme
Key exclusion criteria (5 listed)
- Protected person: safeguard of justice
- Swallowing disorder having a contra-indication to the texture of hand-eating meals.
- Lack of motor skills in both hands
- Specific diet: pleasure diet, salt-free, sugar-free, fiber-free, artificial nutrition
- Wearer of a pacemaker
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 |
|---|---|---|
| Hand-EatingAlso: EXPERIMENTALeat-hands type food mode | Other | Experimental |
| ControlAlso: Control groupUsual eating mode | Other | Control |
Primary outcome
Audit & Questionnaire of feasibility
Time frame: After 3 patients included and at the end of study (6 months)
Feasibility of implementing finger food for elderly patients in care settings will be evaluate with audit and questionnaire for caregivers by a dietician independent of the study.
5 secondary outcomes
Weight
Time frame: Every two weeks during 6 months
Food consumption
Time frame: Each week during 6 months
Autonomy (EBS)
Time frame: Every month during 6 months
Eating pleasure
Time frame: Every month during 6 months
False routes
Time frame: Every week during 6 months
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 24 Nov 2025.
- 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.
Laura COUTON study director
CHU Tours
Laura COUTON principal investigator
CHU Tours
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hand-Eating in people with Undernutrition and Elderly Person, run by University Hospital, Tours at 2 sites 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 14 inclusion and 5 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 24 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Contact Laura COUTON (+33247478568, L.COUTON@chu-tours.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Audit & Questionnaire of feasibility (time frame: After 3 patients included and at the end of study (6 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 24 Nov 2025.