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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05389098
Recruitment Status : Not yet recruiting
First Posted : May 24, 2022
Last Update Posted : May 24, 2022
Sponsor:
Information provided by (Responsible Party):
University Hospital, Tours

Study Description
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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
Undernutrition Elderly Person Other: Hand-Eating Other: Control Not Applicable

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
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Randomized 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
Estimated Study Start Date : October 15, 2022
Estimated Primary Completion Date : October 15, 2023
Estimated Study Completion Date : April 15, 2024
Arms and Interventions
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Arm Intervention/treatment
Experimental: Experimental
eat-hands type food mode
 Other: Hand-Eating
eat-hands type food mode
Other Name: EXPERIMENTAL
Active Comparator: Control
Usual food administration
 Other: Control
Usual eating mode
Other Name: Control group


Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  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.


Eligibility Criteria
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Ages Eligible for Study:   75 Years to 120 Years   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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 Eating Behaviour Scale (Tully) <12/18
  • 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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05389098


Contacts
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Contact: Laura COUTON +33247478568 L.COUTON@chu-tours.fr
Contact: Wiebe de JONG, MSc +33247474680 w.dejong@chu-tours.fr

Locations
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France
EPHAD "Le Clos Mignot"
Luynes, France, 37230
Contact: Justine LESSAULT       justine.lessault@chluynes.fr   
Principal Investigator: Justine LESSAULT         
Ehpad L'Ermitage
Tours, France, 37100
Contact: Laura COUTON    +33247478568    L.COUTON@chu-tours.fr   
Contact: Wiebe de JONG, MSc    +33247474680    w.dejong@chu-tours.fr   
Principal Investigator: Laura COUTON         
Sponsors and Collaborators
University Hospital, Tours
Investigators
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Study Director: Laura COUTON CHU Tours
Principal Investigator: Laura COUTON CHU Tours
More Information
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Responsible Party: University Hospital, Tours
ClinicalTrials.gov Identifier: NCT05389098    
Other Study ID Numbers: DR200176-PLAID
ID-RCB ( Registry Identifier: 2021-A01094-37 )
First Posted: May 24, 2022    Key Record Dates
Last Update Posted: May 24, 2022
Last Verified: May 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University Hospital, Tours:
Undernutrition
Elderly Person
Nursing home
Nutrition
Additional relevant MeSH terms:
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Malnutrition
Nutrition Disorders