Finger Food, Pleasure at Your Fingertips: Randomized Pilot Study, Open-label and Parallel Groups
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age75-120
SponsorUniversity Hospital, Tours
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Male or female residents over 75 years old living in a Accommodation facility for dependent elderly people for at least 3 months
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
Dynamometer (kg): < 27 AND calf circumference (cm): < 31
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Hand-Eating
Other interventioneat-hands type food mode
Control
Other interventionUsual eating mode
Treatment groups
30 Participants
are divided into 2 treatment groupsGroup A: ExperimentalExperimental treatment 1 intervention
Group B: ControlActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Audit & Questionnaire of feasibility
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.
Time frame
After 3 patients included and at the end of study (6 months)Secondary outcomes
1
Weight
Weight in kilograms
Time frame
Every two weeks during 6 months2
Food consumption
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.
Time frame
Each week during 6 months3
Autonomy (EBS)
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.
Time frame
Every month during 6 months4
Eating pleasure
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.
Time frame
Every month during 6 monthsSponsors and contacts
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Source ClinicalTrials.gov