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

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

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

Первичные конечные точки

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

Вторичные конечные точки (5)

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

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Организация здравоохранения

Центры проведения

Франция · 2 центра

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

Идентификаторы

NCT: NCT05389098 · DR200176-PLAID · ID-RCB

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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