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

Study Overview
=================
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.

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

Conditions
-----------------
Undernutrition, Elderly Person

Intervention / Treatment
-----------------
* Other: Hand-Eating
* Other: Control


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 75 Years
Maximum Age: 120 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomized Pilot Study, Open-label and Parallel Groups
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental<br>eat-hands type food mode | Other: Hand-Eating<br>* eat-hands type food mode<br>* Other names: EXPERIMENTAL;|
| Active Comparator: Control<br>Usual food administration | Other: Control<br>* Usual eating mode<br>* 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Undernutrition, Elderly Person, Nursing home, Nutrition