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

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.

Study Overview

• Status: Recruiting
• Conditions: Undernutrition; Elderly Person
• Intervention / Treatment: Other: Hand-Eating; Other: Control

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 Type: Interventional
• Enrollment (Estimated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Wiebe de JONG, MSc; Phone Number: +33247474680; Email: w.dejong@chu-tours.fr
• Study Contact Backup: Name: Laura COUTON; Phone Number: +33247478568; Email: L.COUTON@chu-tours.fr

Study Locations

• France
  • Château-Renault, France, 37110
    • Not yet recruiting
    • EHPAD " Val de Brenne " Site : Auzouer en Touraine
    • Contact: Aïssata SABO SAIDOU, MD; Phone Number: 06 71 39 79 32; Email: a.sabosaidou@chicacr.fr
    • Contact: 06 71 39 79 32
    • Principal Investigator: Aïssata SABO SAIDOU, MD
  • Tours, France, 37100
    • Recruiting
    • EHPAD L'ERMITAGE-CHU de TOURS
    • Contact: Wiebe de JONG, MSc; Phone Number: +33247474680; Email: w.dejong@chu-tours.fr
    • Contact: Laura COUTON; Phone Number: +33247478568; Email: L.COUTON@chu-tours.fr
    • Principal Investigator: Laura COUTON

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 75 years to 120 years (Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Experimental; eat-hands type food mode	Other: Hand-Eating; eat-hands type food mode; Other Names: EXPERIMENTAL
Active Comparator: Control; Usual food administration	Other: Control; Usual eating mode; Other Names: Control group

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Weight	Weight in kilograms	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.	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.	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.	Every month during 6 months
False routes	The occurrence of false routes will be collected throughout the study.	Every week during 6 months

Collaborators and Investigators

• Sponsor: University Hospital, Tours
• Investigators: Study Director: Laura COUTON, CHU Tours; Principal Investigator: Laura COUTON, CHU Tours

Study record dates

Study Major Dates

• Study Start (Actual): August 3, 2023
• Primary Completion (Estimated): January 31, 2027
• Study Completion (Estimated): January 31, 2027

Study Registration Dates

• First Submitted: May 16, 2022
• First Submitted That Met QC Criteria: May 20, 2022
• First Posted (Actual): May 24, 2022

Study Record Updates

• Last Update Posted (Actual): November 24, 2025
• Last Update Submitted That Met QC Criteria: November 18, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Keywords: Nutrition; Nursing home; Undernutrition; Elderly Person
• Additional Relevant MeSH Terms: Nutrition Disorders; Nutritional and Metabolic Diseases; Malnutrition; Investigative Techniques; Epidemiologic Research Design; Epidemiologic Methods; Research Design; Methods; Control Groups
• Other Study ID Numbers: DR200176-PLAID; ID-RCB (Other Identifier: 2025-A02239-40)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No