Sustainable Eating Pattern to Limit Malnutrition in Older Adults (SENIOR)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 303
- 试验地点
- 1
- 主要终点
- Prevalence of malnutrition in free-living and hospitalized older adults
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 65 Years 至 120 Years（Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age ≥ 65 years old
- •Admission to U.O. of General Medicine and to U.O.S.D. of Endocrinology and Metabolic diseases of ICS Maugeri IRCCS Hospital; to the Division and Specialist Gastroenterology Clinic of the IRCCS Policlinico San Matteo Foundation, Pavia, Italy; to the Department of Neurology and Geriatrics of the IRCCS San Gerardo dei Tintori Foundation, Monza, Italy
- •Informed consent written and signed
排除标准
- •Dysphagia
- •Terminal disease
- •History of bariatric surgery
- •Dementia or cognitive decline (MMSE score <20/30)
- •Eating disorder
- •Patients with tumor diagnosis not in remission and currently not treated with oncological therapy
- •Advanced liver failure (CHILD ≥ B)
- •Advanced renal failure (eGFR < 15 mL/min/1.73m ^2 )
- •Advanced chronic or acute respiratory failure (pO2 < 60 mmHg or PCO2 > 45 mmHg)
结局指标
主要结局
Prevalence of malnutrition in free-living and hospitalized older adults
时间窗: Day 1
Malnutrition diagnosis (GLIM) with Malnutrition Universal Screening Tool (MUST) screening tool
次要结局
- Level of quality of life in free-living and hospitalized older adults(Day 1)
- Level of depression in free-living and hospitalized older adults(Day 1)
- Prevalence of sarcopenia in free-living and hospitalized older adults(Day 1)
- Level of physical activity in free-living and hospitalized older adults(Day 1)
- Level of adherence to Mind Diet in free-living and hospitalized older adults(Day 1)
- Sleep quality in free-living and hospitalized older adults(Day 1)
- Level of adherence to Mediterranean diet in free-living and hospitalized older adults(Day 1)
- Socio-demographic characteristic in free-living and hospitalized older adults(Day 1)
- Level of intrinsic capacity in free-living and hospitalized older adults(Day 1)
- Potential correlation between blood biomarkers and malnutrition in free-living and hospitalized older adults(Day 1)
研究者
Hellas Cena
Pro-Rector for Third Mission; Professor of Dietetics and Clinical Nutrition; Human Nutrition Researcher and Head of the Clinical Nutrition Laboratory
University of Pavia