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NCT Number: NCT05389098

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

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.

Recruiting

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Key information

Age range

75 year–120 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

EHPAD " Val de Brenne " Site : Auzouer en Touraine, Château-Renault, France

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Hand-Eating

Other

eat-hands type food mode

Other names: EXPERIMENTAL

Control

Other

Usual eating mode

Other names: Control group

Primary outcomes

  1. 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.

Secondary outcomes

  1. Weight

    Time frame: Every two weeks during 6 months

    Weight in kilograms

  2. Food consumption

    Time frame: Each week during 6 months

    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.

  3. Autonomy (EBS)

    Time frame: Every month during 6 months

    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.

  4. Eating pleasure

    Time frame: Every month during 6 months

    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.

  5. False routes

    Time frame: Every week during 6 months

    The occurrence of false routes will be collected throughout the study.

Study contacts

Contact information is provided by the study sponsor or research team.

Laura COUTON

CONTACT

[email protected]

+33247478568

Wiebe de JONG, MSc

CONTACT

[email protected]

+33247474680

Sponsors and collaborators

Lead sponsor

University Hospital, Tours

Other

Registry information

Official study title

L'Alimentation Manger-mains, le Plaisir au Bout Des Doigts : Etude Pilote randomisée, en Ouvert et en Groupes parallèles

Acronym: PLAID

Important dates

Study start
2023
Primary completion
2027
Study completion
2027
First posted
May 24, 2022
Registry last updated
Nov 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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