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

Official title

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

Overview

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.

Interventions

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

Primary outcome measures

• Audit & Questionnaire of feasibility [Time frame: After 3 patients included and at the end of study (6 months)]

Secondary outcome measures (5)

• Weight [Time frame: Every two weeks during 6 months]
• Food consumption [Time frame: Each week during 6 months]
• Autonomy (EBS) [Time frame: Every month during 6 months]
• Eating pleasure [Time frame: Every month during 6 months]
• False routes [Time frame: Every week during 6 months]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Health services research

Study locations

France · 2 centers

• EHPAD " Val de Brenne " Site : Auzouer en Touraine — Château-Renault
• EHPAD L'ERMITAGE-CHU de TOURS — Tours

Identifiers

NCT: NCT05389098 · DR200176-PLAID · ID-RCB

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗