Nutritional Support in Patients With Nutritional Risk. How we Can Improved the Prognosis and Quality of Life

Clalit Health Services

Status: Terminated

Conditions: Malnutrition; Quality of Life

Treatments: Dietary Supplement: Food dish; Behavioral: Questioners; Diagnostic Test: Bioimpedance; Dietary Supplement: Plated food dish; Diagnostic Test: Indirect calorimetric

Study type: Interventional

Funder types: Other

Identifiers

NCT05299541

0390-16-RMC

Details and patient eligibility

About

Background: Many malnourished hospital patients remain after discharge. We aimed to enhance the meal experience after discharge by delivering meals together with physical support at the home and tested if this increased food intake affected survival and quality of life.

Patients and Methods: 60 discharged patients suffering from nutritional (MUST>2) and financial frailty were included. Control group (C) took their regular nutrition at home for 6 months and study group (S) received a daily dinner tray sponsored by the municipality. Hazalla philanthropic organization encouraged the patients at lunch for 6 months. Body composition (Quadstat 4000, Bodystat, UK), energy requirements (Fitmate- COSMED, Italy) were measured at recruitement. Primary outcome was 180 days survival. In addition, in the recruitment stage and after a period of 3 and 6 months, depression and anxiety questionnaire (HADS), quality of Life Questionnaire-SF36and FIM questionnaire - designed to examine the level of independence of patients with disability were performed at days 0, 90 and 180. Statistical analysis used T- Test and ANOVA Repeated Measures. The study was approved by local IRB.

Enrollment: 60 patients

Sex: All

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• MUST =>2
• Region of living Bney-Brak or Petah-tikwa
• Fine cognitive state

Exclusion criteria

• Progressive cancer
• Dementia
• Fiddling by PEG or Enteral nutrient via Naso gastric tube
• Psychiatrics disorder

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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60 participants in 3 patient groups

Control

Active Comparator group

Description:

Measurements and questioners

Treatment:

Diagnostic Test: Bioimpedance

Diagnostic Test: Indirect calorimetric

Behavioral: Questioners

Group A

Active Comparator group

Description:

Receiving Food dish every night for 6 months Measurements and questioners

Treatment:

Diagnostic Test: Bioimpedance

Dietary Supplement: Food dish

Diagnostic Test: Indirect calorimetric

Behavioral: Questioners

Group B

Active Comparator group

Description:

Receiving Food dish every night for 6 months, at this group extra attention have given to the dish plating and appearance by professional (BOCUSE), Measurements and questioners

Treatment:

Diagnostic Test: Bioimpedance

Dietary Supplement: Plated food dish

Diagnostic Test: Indirect calorimetric

Behavioral: Questioners