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

Regional University Hospital Center (CHRU)

Status: Enrolling

Conditions: Elderly Person; Undernutrition

Treatments: Other: Control; Other: Hand-Eating

Study type: Interventional

Funder types: Other

Identifiers

NCT05389098

DR200176-PLAID

ID-RCB (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 30 estimated patients

Sex: All

Ages: 75 to 120 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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30 participants in 2 patient groups

Experimental

Experimental group

Description:

eat-hands type food mode

Treatment:

Other: Hand-Eating

Control

Active Comparator group

Description:

Usual food administration

Treatment:

Other: Control