NCT05389098

Brief 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
9mo left

Started Aug 2023

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress79%
Aug 2023Jan 2027

First Submitted

Initial submission to the registry

May 16, 2022

Completed
8 days until next milestone

First Posted

Study publicly available on registry

May 24, 2022

Completed
1.2 years until next milestone

Study Start

First participant enrolled

August 3, 2023

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2027

Last Updated

November 24, 2025

Status Verified

November 1, 2025

Enrollment Period

3.5 years

First QC Date

May 16, 2022

Last Update Submit

November 18, 2025

Conditions

UndernutritionElderly Person

Keywords

UndernutritionElderly PersonNursing homeNutrition

Outcome Measures

Primary Outcomes (1)

  • 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.

    After 3 patients included and at the end of study (6 months)

Secondary Outcomes (5)

  • Weight

    Every two weeks during 6 months

  • Food consumption

    Each week during 6 months

  • Autonomy (EBS)

    Every month during 6 months

  • Eating pleasure

    Every month during 6 months

  • False routes

    Every week during 6 months

Study Arms (2)

Experimental

EXPERIMENTAL

eat-hands type food mode

Other: Hand-Eating

Control

ACTIVE COMPARATOR

Usual food administration

Other: Control

Interventions

Hand-EatingOTHER

eat-hands type food mode

Also known as: EXPERIMENTAL
Experimental
ControlOTHER

Usual eating mode

Also known as: Control group
Control

Eligibility Criteria

Age75 Years - 120 Years
Sexall
Healthy VolunteersYes
Age GroupsOlder Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

EHPAD " Val de Brenne " Site : Auzouer en Touraine

Château-Renault, 37110, France

NOT YET RECRUITING

EHPAD L'ERMITAGE-CHU de TOURS

Tours, 37100, France

RECRUITING

MeSH Terms

Conditions

Malnutrition

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Nutrition DisordersNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Epidemiologic Research DesignEpidemiologic MethodsInvestigative TechniquesResearch DesignMethods

Study Officials

  • Laura COUTON

    CHU Tours

    STUDY DIRECTOR

  • Laura COUTON

    CHU Tours

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Laura COUTON

CONTACT

+33247478568L.COUTON@chu-tours.fr

Wiebe de JONG, MSc

CONTACT

+33247474680w.dejong@chu-tours.fr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Model Details: Randomized Pilot Study, Open-label and Parallel Groups
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 16, 2022

First Posted

May 24, 2022

Study Start

August 3, 2023

Primary Completion (Estimated)

January 31, 2027

Study Completion (Estimated)

January 31, 2027

Last Updated

November 24, 2025

Record last verified: 2025-11

Data Sharing

IPD Sharing
Will not share

Locations

FR(2)