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

Sponsor
University Hospital, Tours (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05389098
Collaborator
(none)
30
2
2
18
15
0.8

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Hand-Eating
  • Other: Control
N/A

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

Study Type:
Interventional
Anticipated Enrollment :
30 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Randomized Pilot Study, Open-label and Parallel GroupsRandomized Pilot Study, Open-label and Parallel Groups
Masking:
None (Open Label)
Primary Purpose:
Health Services Research
Official Title:
L'Alimentation Manger-mains, le Plaisir au Bout Des Doigts : Etude Pilote randomisée, en Ouvert et en Groupes parallèles
Anticipated Study Start Date :
Oct 15, 2022
Anticipated Primary Completion Date :
Oct 15, 2023
Anticipated Study Completion Date :
Apr 15, 2024

Arms and Interventions

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
  • Outcome Measures

    Primary Outcome Measures

    1. Audit & Questionnaire of feasibility [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 Outcome Measures

    1. Weight [Every two weeks during 6 months]

      Weight in kilograms

    2. Food consumption [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) [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 [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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    75 Years to 120 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:
    • Male or female residents over 75 years old living in a Accommodation facility for dependent elderly people for at least 3 months

    • Involuntary weight loss of at least 5% in 1 month or 10% in 6 months or 10% compared to the usual weight

    • 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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 EHPAD "Le Clos Mignot" Luynes France 37230
    2 EHPAD L'ERMITAGE-CHU de TOURS Tours France 37100

    Sponsors and Collaborators

    • University Hospital, Tours

    Investigators

    • Study Director: Laura COUTON, CHU Tours
    • Principal Investigator: Laura COUTON, CHU Tours

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    University Hospital, Tours
    ClinicalTrials.gov Identifier:
    NCT05389098
    Other Study ID Numbers:
    • DR200176-PLAID
    • ID-RCB
    First Posted:
    May 24, 2022
    Last Update Posted:
    Jul 7, 2022
    Last Verified:
    Jul 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by University Hospital, Tours
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Jul 7, 2022