Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05389098
Other study ID # DR200176-PLAID
Secondary ID ID-RCB
Status Recruiting
Phase N/A
First received
Last updated
Start date August 3, 2023
Est. completion date February 3, 2025

Study information

Verified date August 2023
Source University Hospital, Tours
Contact Laura COUTON
Phone +33247478568
Email L.COUTON@chu-tours.fr
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 30
Est. completion date February 3, 2025
Est. primary completion date August 3, 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 75 Years to 120 Years
Eligibility 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


Related Conditions & MeSH terms


Intervention

Other:
Hand-Eating
eat-hands type food mode
Control
Usual eating mode

Locations

Country Name City State
France EHPAD " Val de Brenne " Site : Auzouer en Touraine Château -Renault
France EHPAD L'ERMITAGE-CHU de TOURS Tours

Sponsors (1)

Lead Sponsor Collaborator
University Hospital, Tours

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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. After 3 patients included and at the end of study (6 months)
Secondary Weight Weight in kilograms Every two weeks during 6 months
Secondary 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. Each week during 6 months
Secondary 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.
Every month during 6 months
Secondary 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. Every month during 6 months
Secondary False routes The occurrence of false routes will be collected throughout the study. Every week during 6 months
See also
  Status Clinical Trial Phase
Recruiting NCT06084715 - The INSTITUT Study
Recruiting NCT05608707 - APPETITE: Plant Protein and Exercise Solutions for the Prevention of Undernutrition in Older Adults. N/A
Completed NCT01977950 - Nutritional Risk and Nutritional Care Practices in the Hospitalized Elderly N/A
Completed NCT01197768 - A Multi-Component Behavioral Nutrition Intervention for Homebound Elderly N/A
Active, not recruiting NCT02463565 - Assessment of Food Intake in Hospitalized Patients N/A
Completed NCT05517395 - The Effectiveness of HBM-based Education Program on Improve Knowledge and Behaviors N/A
Recruiting NCT05473312 - Women Supporting Women to Improve Infant and Child Feeding Practices N/A
Recruiting NCT05094024 - Shelf-Stable MDCF-2 for Children With Undernutrition N/A
Completed NCT04105621 - Westlake Personalized Nutrition and Health Cohort for Drug Addicts
Completed NCT02213393 - Cater With Care Effect Study N/A
Completed NCT02141256 - Can Protein Intake be Increased by Offering Protein-enriched Foods and Drinks? N/A
Active, not recruiting NCT03450174 - Effectiveness of Multiple Micro-nutrient Fortified Fudge on Nutritional Status of 3-5 Years of Age Children N/A
Completed NCT05574842 - The Effect of Double Duty Interventions on Double Burden of Malnutrition Among School Adolescents in Ethiopia N/A
Recruiting NCT05952479 - The Comparison of Handgrip Strength, Lean Mass, and Blood Pressure in Primary School Children Aged 8-10 Years Old With Undernutrition and Normal Nutritional Status
Completed NCT04640389 - Rural-urban Disparities in the Nutritional Status of Younger Adolescents in Tanzania.
Completed NCT03378141 - Maternal Nutrition Interventions in Uttar Pradesh, India N/A
Completed NCT03211845 - Feasibility of Nutritional Telemonitoring in Elderly Home Care Patients N/A
Completed NCT02656186 - Supplementation With Nutrients Modulating IGF-1 and Cytokines in Elderly People at Risk of Undernutrition Phase 3
Completed NCT02496247 - Canned Herring for Prevention of Childhood Malnutrition During the Early Rainy Season in Rural Guinea-Bissau N/A
Completed NCT02476110 - The ONSHUG Survey : A Quality Care Programme N/A