Finger Food, Pleasure at Your Fingertips: Randomized Pilot Study, Open-label and Parallel Groups

NCT ID: NCT05389098

Last Updated: 2025-11-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-08-03

Study Completion Date

2027-01-31

Brief Summary

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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

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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

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Undernutrition Elderly Person

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Randomized Pilot Study, Open-label and Parallel Groups
Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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Experimental

eat-hands type food mode

Group Type EXPERIMENTAL

Hand-Eating

Intervention Type OTHER

eat-hands type food mode

Control

Usual food administration

Group Type ACTIVE_COMPARATOR

Control

Intervention Type OTHER

Usual eating mode

Interventions

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Hand-Eating

eat-hands type food mode

Intervention Type OTHER

Control

Usual eating mode

Intervention Type OTHER

Other Intervention Names

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EXPERIMENTAL Control group

Eligibility Criteria

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Inclusion Criteria

* 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):

* 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

Exclusion Criteria

* 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
Minimum Eligible Age

75 Years

Maximum Eligible Age

120 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University Hospital, Tours

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Laura COUTON

Role: STUDY_DIRECTOR

CHU Tours

Laura COUTON

Role: PRINCIPAL_INVESTIGATOR

CHU Tours

Locations

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EHPAD " Val de Brenne " Site : Auzouer en Touraine

Château-Renault, , France

Site Status NOT_YET_RECRUITING

EHPAD L'ERMITAGE-CHU de TOURS

Tours, , France

Site Status RECRUITING

Countries

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France

Central Contacts

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Laura COUTON

Role: CONTACT

+33247478568

Wiebe de JONG, MSc

Role: CONTACT

+33247474680

Facility Contacts

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Aïssata SABO SAIDOU, MD

Role: primary

06 71 39 79 32

06 71 39 79 32

Role: backup

Laura COUTON

Role: primary

+33247478568

Wiebe de JONG, MSc

Role: backup

+33247474680

Other Identifiers

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ID-RCB

Identifier Type: REGISTRY

Identifier Source: secondary_id

DR200176-PLAID

Identifier Type: -

Identifier Source: org_study_id

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