The SENIOR STUDY is aimed at improving the condition of older adults and malnutrition management in and out Italian hospital settings, since malnutrition is highly prevalent, clinically relevant and potentially treatable condition. This study consist of two phases: an initial cross-sectional phase and a secondary nutritional intervention phase (RCT). The SENIOR CROSS-SECTIONAL study aims to map malnutrition status in accordance with the most recent GLIM criteria and investigate the association between malnutrition and anthropometric, demographic and socioeconomic, and lifestyle factors. In addition, sarcopenia will be diagnosed (EWGSOP2 consensus criteria) and blood markers will be measured. Malnutrition in Italian hospital setting is highly prevalent but the current malnutrition data prevalence and the general characteristics of older adults are not updated. Thus, it is expected to find a high malnutrition prevalence and an inadequate nutritional status.
The SENIOR cross-sectional study is a multicenter study conducted in three North Italian Scientific Hospitalization and Treatment Institutions in Pavia and Monza on older adults (≥ 65 years old). The estimated duration is 36 months with an preferred starting date on November 2023. The primary objective of the SENIOR cross-sectional is the evaluation of the nutritional status in at least a total of 200 free-living and hospitalized older adults. Therefore, the primary endpoint is to define the malnutrition prevalence in free-living and hospitalized older adults with GLIM criteria, which is the most update recent international consent. As secondary objectives, the definition of the prevalence of sarcopenia (according to EWGSOP2 diagnosis) and a mapping of other relevant factors potentially associated with malnutrition will be carried out on the population target: lifestyle, socioeconomic status, anthropometric measures, clinical condition including medical treatment and blood analysis. In addition, the impact of these factors on health status of the target population will be investigated, potentially leading to the identification of new malnutrition risk factors. To the over 65 older adults, admitted at the three hospitals for medical visits or recovery, will be proposed to participate to the SENIOR cross-sectional study. After the participants' signature of the informed consent, the clinical and pathological information will be gathered to assess the eligibility. On eligible subject different variables will be measured. Dietary habits will be evaluated through a Mediterranean diet questionnaire (MEDI-LITE) and the MIND diet questionnaire. Physical activity will be evaluated with the Physical Activity Scale for the Elderly (PASE) questionnaire and activities of daily living will be assessed through Barthel Index. Sleep quality will be investigated with Pittsburgh questionnaire. Emotional status of participants will be examined with the Geriatric Depression Scale 15 item (GDS-15). Quality of life will be measured with SF-12 questionnaire. Ending, vitamin D deficiency will be evaluated with the Evidence Q questionnaire. Anthropometric variables will include weight, height (knee height and demi-span), circumferences (waist, mid-arm, calf and medium tight), and body composition (bioimpedance analysis, BIA). In addition, muscle strength (handgrip) and physical performance (4-meter gait speed) will be evaluated. Malnutrition will be diagnosed according to the 2019 GLIM criteria using a two-step approach. Participants will be first screened with Malnutrition Universal Screening Tool (MUST), followed by diagnostic assessment requiring at least one phenotypic criterion (weight loss, low BMI, or reduced appendicular skeletal muscle mass derived from BIA) and one etiologic criterion (reduced intake or inflammation/disease burden). Severity grading will be also performed. Muscle strength (handgrip), Appendicular Skeletal Mass (ASM, derived from BIA) and locomotion (gait speed) will be used to diagnose sarcopenia according to the European Working Group on Sarcopenia in Older People 2 (EWGSOP2) consensus. Intrinsic capacity, a marker of healthy aging promoted by the World Health Organisation (WHO), will be also assessed, exploring the following domains: locomotion, vitality, cognition, psychological status, and sensory function. Blood analysis will be carried out on a subgroup to evaluate the participants' inflammatory, nutritional and clinical status. Data from medical records will be used to calculate the Cumulative Illness Rating Scale (CIRS) score, a gold-standard measure of overall disease burden. The CIRS-based comorbidity and severity indices quantify an individual's health status, with lower scores indicating lower burden and higher scores indicating greater severity and comorbidity. Finally, information on medication use at hospital admission (number and active substances) and hospitalizations in the previous year (yes/no) will be retrieved from medical records, based on prior structured interviews. Length of stay will be obtained from discharge letters and defined as the number of days spent in the hospital for each inpatient.
Study Type
OBSERVATIONAL
Enrollment
303
U.O. of General Medicine and U.O.S.D. of Endocrinology and Metabolic diseases of ICS Maugeri IRCCS Hospital, Pavia
Pavia, PV, Italy
Prevalence of malnutrition in free-living and hospitalized older adults
Malnutrition diagnosis (GLIM) with Malnutrition Universal Screening Tool (MUST) screening tool
Time frame: Day 1
Prevalence of sarcopenia in free-living and hospitalized older adults
Sarcopenia diagnosis (EWGSOP2)
Time frame: Day 1
Level of physical activity in free-living and hospitalized older adults
Physical Activity Scale for the Elderly questionnaire. Total score ranges from 0 to 450 and an higher score represents a higher level of physical activity. OR Barthel Index. The total score ranges from 0 to 100. The lower score indicates a totally dependent and a higher score indicates a higher independence in daily activities
Time frame: Day 1
Activities of daily living
Barthel Index. The total score ranges from 0 to 100. The lower score indicates a totally dependency and a higher score indicates a higher independence in daily activities.
Time frame: Day 1
Level of adherence to Mediterranean diet in free-living and hospitalized older adults
Medi-Lite adherence score questionnaire. Total score ranges between 0-18. A high score represents a higher adherence to Mediterranean diet
Time frame: Day 1
Level of adherence to Mind Diet in free-living and hospitalized older adults
Mind diet score. Total score ranges from 0 to 15. A higher score indicate a higher adherence to Mind Diet
Time frame: Day 1
Sleep quality in free-living and hospitalized older adults
pittsburgh sleep quality index. Total score ranges between 0-21. A higher score represents higher sleep difficulties
Time frame: Day 1
Level of quality of life in free-living and hospitalized older adults
Short-Form Health Survey 12. Total score ranges between 0-100. A higher score represents a better quality of life
Time frame: Day 1
Level of intrinsic capacity in free-living and hospitalized older adults
The scores of the following domains will be summarized to calculate the intrinsic capacity total score, which ranges from 0 to 10. A higher score represents a higher intrinsic capacity: * Locomotion (4-m gait speed) (m/s); score ranges between 0-2 * Vitality (malnutrition according to GLIM criteria); score ranges between 0-2 * Cognition (Mini Mental State Examination); score ranges between 0-2 * Psychological state (Geriatric Depression Scale 15 items); score ranges between 0-2 * Sensory function (vision and hearing): score ranges between 0-2
Time frame: Day 1
Level of depression in free-living and hospitalized older adults
Geriatric Depression Scale. Total score ranges between 0-15. A higher score represents higher depression status
Time frame: Day 1
Potential correlation between blood biomarkers and malnutrition in free-living and hospitalized older adults
Biomarkers blood measured from fasting blood samples are: Complete blood count with leukocyte count (Red blood cell count (10 \^12 /l), White blood cell count (10 \^9 /l), Pateletes (10 \^9 /l), Hemoglobine (g/l), haematocrit (%), prothrombin/INR (sec)); Lipid profile (Low density lipoprotein, high density lipoprotein, total cholesterol, triglycerides) (mg/dl); Uric acid (mg/dl); C reactive Protein (CRP) (mg/dl) Plasmatic creatinine (mg/dl) Transaminases (glutamic oxaloacetic transaminase, Glutamic-Pyruvic Transaminase, gamma-glutamyl transferase) (U/I) Alkaline phosphatase (U/L) Creatin Kinase (UI/L) Prealbumin (g/mL) Cytokine (interleukin-1β, interleukin-6, interleukin-10, tumor necrosis factor-α, transforming tumor factor-β) (pg/ml) Glycemia (mg/dl) Insulin (µU/mL) Homocysteine (µmol/L) Vitamines (D (ng/ml), B12 (pg/ml), B9 (ng/ml)) Minerals (Na (mmol/L), K (mmol/L), Mg (mg/dl), Ca (mg/dl), Fe (µg/dl), Zn (mg/dl))
Time frame: Day 1
Socio-demographic characteristic in free-living and hospitalized older adults
Structured interview (sex, age, ethnicity, marital status, level of education, socioeconomic status, e.g. household, occupation, residential area, people in the house, and social support)
Time frame: Day 1
Vitamin D deficiency in free-living and hospitalized older adults
Evaluation Vitamin D dEficieNCy Questionnaire (EVIDENCe-Q). Total range from 0 (better status) to 36 (worsen status).
Time frame: Day 1
Body Mass Index (BMI) in free-living and hospitalized older adults
Weight (kg) with a calibrated weighing scale; height derived by demi-span (cm) through validated equation. Weight and height derived by demi-span will be combined to report BMI in kg/m\^2)
Time frame: Day 1
Height derived by knee height in free-living and hospitalized older adults
Height derived by knee height (cm) through validated equation.
Time frame: Day 1
Referred height in free-living and hospitalized older adults
Referred height (cm) with a structured question
Time frame: Day 1
Waist circumference in free-living and hospitalized older adults
Waist circumference (cm) through an anelastic tape.
Time frame: Day 1
Mid-arm circumference in free-living and hospitalized older adults
Mid-arm circumference (cm) through an anelastic tape.
Time frame: Day 1
Calf circumference in free-living and hospitalized older adults
Calf circumference (cm) through an anelastic tape.
Time frame: Day 1
Mid-thigh circumference in free-living and hospitalized older adults
Mid-thigh circumference (cm) measured with an anelastic tape
Time frame: Day 1
Fat-Free Mass (FFM) in free-living and hospitalized older adults
Fat-Free Mass (FFM, KG) measured by Bioelectrical Impedance Analysis (BIA)
Time frame: Day 1
Fat Mass (FM) in free-living and hospitalized older adults
Fat Mass (FM, kg) measured by Bioelectrical Impedance Analysis (BIA)
Time frame: Day 1
Body Water in free-living and hospitalized older adults
Total Body Water (TBW, l), Extracellular Water (ECW, l) and Intracellular Water (ICW, l) measured by Bioelectrical Impedance Analysis (BIA)
Time frame: Day 1
Phase angle in free-living and hospitalized older adults
Phase angle (θ) measured by Bioelectrical Impedance Analysis (BIA)
Time frame: Day 1
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