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

Undernutrition Clinical Trial

— PLAID  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05389098
• Other study ID #: DR200176-PLAID
• Secondary ID: ID-RCB
• Status: Recruiting
• Phase: N/A
• Start date: August 3, 2023
• Est. completion date: February 3, 2025

Study information

• Verified date: August 2023
• Source: University Hospital, Tours
• Contact: Laura COUTON
• Phone: +33247478568
• Email: L.COUTON[@]chu-tours.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: February 3, 2025
• Est. primary completion date: August 3, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 75 Years to 120 Years

Eligibility

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

Related Conditions & MeSH terms

• Elderly Person
• Malnutrition
• Undernutrition

Intervention

Other:
• Hand-Eating
eat-hands type food mode
• Control
Usual eating mode

Locations

Country	Name	City	State
France	EHPAD " Val de Brenne " Site : Auzouer en Touraine	Château -Renault
France	EHPAD L'ERMITAGE-CHU de TOURS	Tours

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Tours

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Weight	Weight in kilograms	Every two weeks during 6 months
Secondary	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
Secondary	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
Secondary	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
Secondary	False routes	The occurrence of false routes will be collected throughout the study.	Every week during 6 months