An interventional study of Food dish and Indirect calorimetric in Malnutrition and Quality of Life, sponsored by Rabin Medical Center. Terminated at 1 site in Israel. Open to participants aged 18 Years to 90 Years. Per ClinicalTrials.gov, last updated 2022-03-29.
Sponsored by Rabin Medical Center · Not applicable, Interventional, and Prevention
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.
1,587 studies on the registry are indexed under Malnutrition; 237 are open to participants now.
This study's enrollment of 60 is below the median of 90 across 1,134 interventional studies indexed under Malnutrition.
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Exclusion Criteria:
Measurements and questioners
Diagnostic Test: Indirect calorimetric · Diagnostic Test: Bioimpedance · Behavioral: Questioners
Receiving Food dish every night for 6 months Measurements and questioners
Dietary Supplement: Food dish · Diagnostic Test: Indirect calorimetric · Diagnostic Test: Bioimpedance · Behavioral: Questioners
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
Diagnostic Test: Indirect calorimetric · Diagnostic Test: Bioimpedance · Behavioral: Questioners · Dietary Supplement: Plated food dish
All patients will be assessed for nutritional risk estimates (MUST) as well as a nutritional PANDORA estimate that predicts mortality, the Pandora estimate will be measured even after 3 and 6 months Group A - will receive a dish of food every evening by a person employed by a rescue organization for 6 months At the end of the meal once a week * All dishes will be photographed at the end of the meal by Android camera, iPhone * A NUTRITION DAY success photo form will be completed and collected .
• The patient will be measured with an indirect calorimetry device (Fitmate - COSMED Srl. Rome, Italy) to assess the nutritional requirement.
• The body composition test will be performed by the Bodystat®4000 Bioimpedance Device (BIA 4000, Bodystat, UK). .
At 3 times point , in the recruit + 3 month and 6 month 3 questioners will be given: HADS, Quality of life 36SF and FIM
All patients will be assessed for nutritional risk estimates (MUST) as well as a nutritional PANDORA estimate that predicts mortality, the Pandora estimate will be measured even after 3 and 6 months Group b - will receive a food dish every evening by a person employed by a rescue organization with improved appearance of a plate for 6 months. At the end of the meal once a week * All dishes will be photographed at the end of the meal by Android camera, iPhone * A NUTRITION DAY success photo form will be completed and collected .
Improve quality of life
HADS questionnaire (hospital anxiety ans depression scale), scale 0-21. 0-7: normal; 8-10: borderline; 11-21: abnormal.
Time frame: 6 months
Improve quality of life
FIM questionnaire (functional indepence measure) scale 0 to 7, 1= total asistance, 7=complete independence, the highst score the best.
Time frame: 6 months
Improve quality of life
sf-36 questionnaire (short form health survey), scale 0-100, the highest the score the less disability
Time frame: 6 months
changed Mortality
six mounth follow up through ATD (American Trans Data Corp)
Time frame: 6 months
changed financials costs per patient in health system
follow up through electronic medical records
Time frame: 6 months
Plan to share: No
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This study is terminated, as verified in Mar 2022. You cannot join it, but the record below documents what was studied.
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Rabin Medical Center