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

Not Applicable

Recruiting

• Conditions: Elderly Person; Undernutrition
• Interventions: Other: Hand-Eating; Other: Control

• Registration Number: NCT05389098
• Lead Sponsor: University Hospital, Tours

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.

Study Timeline

• Study First Submitted: 2022-05-16
• Study First Submitted QC: 2022-05-20
• Study First Posted: 2022-05-24
• Status Verified: 2023-08
• Study Start: 2023-08-03
• Last Update Submitted: 2023-08-07
• Last Update Posted: 2023-08-08
• Primary Completion: 2024-08-03
• Study Completion: 2025-02-03

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Experimental	Hand-Eating	eat-hands type food mode
Control	Control	Usual food administration

Primary Outcome Measures

Name	Time	Method
Audit & Questionnaire of feasibility	After 3 patients included and at the end of study (6 months)	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.

Secondary Outcome Measures

Name	Time	Method
Weight	Every two weeks during 6 months	Weight in kilograms
Eating pleasure	Every month during 6 months	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.
Food consumption	Each week during 6 months	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.
False routes	Every week during 6 months	The occurrence of false routes will be collected throughout the study.
Autonomy (EBS)	Every month during 6 months	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.

Trial Locations

Locations (2)

EHPAD L'ERMITAGE-CHU de TOURS; 🇫🇷 Tours, France

EHPAD " Val de Brenne " Site : Auzouer en Touraine; 🇫🇷 Château -Renault, France