Finger Food, Pleasure at Your Fingertips: Randomized Pilot Study, Open-label and Parallel Groups (PLAID)
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|ClinicalTrials.gov Identifier: NCT05389098|
Recruitment Status : Not yet recruiting
First Posted : May 24, 2022
Last Update Posted : May 24, 2022
|Condition or disease||Intervention/treatment||Phase|
|Undernutrition Elderly Person||Other: Hand-Eating Other: Control||Not Applicable|
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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||Randomized Pilot Study, Open-label and Parallel Groups|
|Masking:||None (Open Label)|
|Primary Purpose:||Health Services Research|
|Official Title:||L'Alimentation Manger-mains, le Plaisir au Bout Des Doigts : Etude Pilote randomisée, en Ouvert et en Groupes parallèles|
|Estimated Study Start Date :||October 15, 2022|
|Estimated Primary Completion Date :||October 15, 2023|
|Estimated Study Completion Date :||April 15, 2024|
eat-hands type food mode
eat-hands type food mode
Other Name: EXPERIMENTAL
Active Comparator: Control
Usual food administration
Usual eating mode
Other Name: Control group
- Audit & Questionnaire of feasibility [ Time Frame: 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.
- Weight [ Time Frame: Every two weeks during 6 months ]Weight in kilograms
- Food consumption [ Time Frame: 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.
- Autonomy (EBS) [ Time Frame: 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.
- Eating pleasure [ Time Frame: 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05389098
|Contact: Laura COUTON||+33247478568||L.COUTON@chu-tours.fr|
|Contact: Wiebe de JONG, MScemail@example.com|
|EPHAD "Le Clos Mignot"|
|Luynes, France, 37230|
|Contact: Justine LESSAULT firstname.lastname@example.org|
|Principal Investigator: Justine LESSAULT|
|Tours, France, 37100|
|Contact: Laura COUTON +33247478568 L.COUTON@chu-tours.fr|
|Contact: Wiebe de JONG, MSc +33247474680 email@example.com|
|Principal Investigator: Laura COUTON|
|Study Director:||Laura COUTON||CHU Tours|
|Principal Investigator:||Laura COUTON||CHU Tours|