Clinical trial NCT05389098: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Undernutrition
Elderly Person
Keywords: Undernutrition
Elderly Person
Nursing home
Nutrition
Lead sponsor: University Hospital, Tours
Sponsor class: OTHER
First posted: 2022-05-24
Enrollment: 30
Sex: ALL
Minimum age (years): 75
Maximum age (years): 120
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized Pilot Study, Open-label and Parallel Groups
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

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

Primary outcomes:
measure: Audit & Questionnaire of feasibility
timeFrame: After 3 patients included and at the end of study (6 months)
Secondary outcomes:
measure: Weight
timeFrame: Every two weeks during 6 months
measure: Food consumption
timeFrame: Each week during 6 months
measure: Autonomy (EBS)
timeFrame: Every month during 6 months
measure: Eating pleasure
timeFrame: Every month during 6 months
measure: False routes
timeFrame: Every week during 6 months
Other outcomes:
Locations:
city: Château -Renault
country: France
facility: EHPAD " Val de Brenne " Site : Auzouer en Touraine
city: Tours
country: France
facility: EHPAD L'ERMITAGE-CHU de TOURS
Study officials:
affiliation: CHU Tours
name: Laura COUTON
role: STUDY_DIRECTOR
affiliation: CHU Tours
name: Laura COUTON
role: PRINCIPAL_INVESTIGATOR
References: