Finger Food, Pleasure at Your Fingertips: Randomized Pilot Study, Open-label and Parallel Groups (PLAID)
Primary Purpose
Undernutrition, Elderly Person
Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Hand-Eating
Control
Sponsored by
About this trial
This is an interventional health services research trial for Undernutrition focused on measuring Undernutrition, Elderly Person, Nursing home, Nutrition
Eligibility 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 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
Sites / Locations
- EHPAD " Val de Brenne " Site : Auzouer en Touraine
- EHPAD L'ERMITAGE-CHU de TOURSRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Experimental
Control
Arm Description
eat-hands type food mode
Usual food administration
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Weight
Weight in kilograms
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.
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.
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.
False routes
The occurrence of false routes will be collected throughout the study.
Full Information
NCT ID
NCT05389098
First Posted
May 16, 2022
Last Updated
August 7, 2023
Sponsor
University Hospital, Tours
1. Study Identification
Unique Protocol Identification Number
NCT05389098
Brief Title
Finger Food, Pleasure at Your Fingertips: Randomized Pilot Study, Open-label and Parallel Groups
Acronym
PLAID
Official Title
L'Alimentation Manger-mains, le Plaisir au Bout Des Doigts : Etude Pilote randomisée, en Ouvert et en Groupes parallèles
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 3, 2023 (Actual)
Primary Completion Date
August 3, 2024 (Anticipated)
Study Completion Date
February 3, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Tours
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Undernutrition, Elderly Person
Keywords
Undernutrition, Elderly Person, Nursing home, Nutrition
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomized Pilot Study, Open-label and Parallel Groups
Masking
None (Open Label)
Allocation
Randomized
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Experimental
Arm Type
Experimental
Arm Description
eat-hands type food mode
Arm Title
Control
Arm Type
Active Comparator
Arm Description
Usual food administration
Intervention Type
Other
Intervention Name(s)
Hand-Eating
Other Intervention Name(s)
EXPERIMENTAL
Intervention Description
eat-hands type food mode
Intervention Type
Other
Intervention Name(s)
Control
Other Intervention Name(s)
Control group
Intervention Description
Usual eating mode
Primary Outcome Measure Information:
Title
Audit & Questionnaire of feasibility
Description
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.
Time Frame
After 3 patients included and at the end of study (6 months)
Secondary Outcome Measure Information:
Title
Weight
Description
Weight in kilograms
Time Frame
Every two weeks during 6 months
Title
Food consumption
Description
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.
Time Frame
Each week during 6 months
Title
Autonomy (EBS)
Description
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.
Time Frame
Every month during 6 months
Title
Eating pleasure
Description
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.
Time Frame
Every month during 6 months
Title
False routes
Description
The occurrence of false routes will be collected throughout the study.
Time Frame
Every week during 6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
75 Years
Maximum Age & Unit of Time
120 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Laura COUTON
Phone
+33247478568
Email
L.COUTON@chu-tours.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Wiebe de JONG, MSc
Phone
+33247474680
Email
w.dejong@chu-tours.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Laura COUTON
Organizational Affiliation
CHU Tours
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Laura COUTON
Organizational Affiliation
CHU Tours
Official's Role
Principal Investigator
Facility Information:
Facility Name
EHPAD " Val de Brenne " Site : Auzouer en Touraine
City
Château -Renault
ZIP/Postal Code
37110
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Aïssata SABO SAIDOU, MD
Phone
06 71 39 79 32
Email
a.sabosaidou@chicacr.fr
First Name & Middle Initial & Last Name & Degree
06 71 39 79 32
First Name & Middle Initial & Last Name & Degree
Aïssata SABO SAIDOU, MD
Facility Name
EHPAD L'ERMITAGE-CHU de TOURS
City
Tours
ZIP/Postal Code
37100
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Laura COUTON
Phone
+33247478568
Email
L.COUTON@chu-tours.fr
First Name & Middle Initial & Last Name & Degree
Wiebe de JONG, MSc
Phone
+33247474680
Email
w.dejong@chu-tours.fr
First Name & Middle Initial & Last Name & Degree
Laura COUTON
12. IPD Sharing Statement
Plan to Share IPD
No
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Finger Food, Pleasure at Your Fingertips: Randomized Pilot Study, Open-label and Parallel Groups
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