Impact of the Introduction of a New Qualitative Composition of the Evening Meal on the Feeding Behavior of Institutionalized Residents of a Long-term Care Unit: a Randomized, Single Center Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 48
- 试验地点
- 2
- 主要终点
- Total caloric ration for each dish
研究概览
简要总结
The main objective of this study was to evaluate and compare 6-month calorie intakes between a group of patients receiving a standard dinner and a group of patients whose evening meal is "improved"; compliance will be assessed on a food card with 5 levels of consumption: no (0%), 25%, 50%, 75%, all (100%). This per patient per meal food card will be prepared 3 days per month for 6 months and will, from the total calorie intake of each dish, estimate calorie intake ingested per day on all meals of the day.
详细描述
The secondary objectives of this study are to evaluate the two groups for the following:
A. The difference between 0 and 6 months in: the patient's weight, calorie intake, serum prealbumin, albumin and CRP, blood sugar for diabetic patients.
B. Monthly evolution over 6 months: calorie intake, the patient's weight. C. The quarterly trend over 6 months: serum prealbumin, albumin and CRP, blood sugar for diabetic patients.
D. Comorbidities and mortality. E. the risk of morning hypoglycaemia for diabetic patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 75 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The subject or his/her representative must be given free and informed consent and must have signed the consent
- •The subject must be affiliated with or beneficiary of a health insurance plan
- •The subject has lived for at least 3 months in the institution
- •The subject is fed by mouth only
排除标准
- •The subject is participating in another study
- •The subject is in an exclusion period determined by a previous study
- •The subject or his/her legal representative refuses to sign the consent
- •It is not possible to correctly inform the subject or his/her representative
结局指标
主要结局
Total caloric ration for each dish
时间窗: 6 months
Meal compliance for 3 days
时间窗: 6 months
Ingested caloric intake
时间窗: 6 months
次要结局
- Meal compliance for 3 days(Month 5)
- Serum prealbumin(Month 6)
- Total caloric ration for each dish(Month 5)
- Serum albumin(Month 6)
- Ingested caloric intake(Month 5)
- Serum C reactive protein(Month 6)
- Weight (kg)(Month 6)
- Glycated hemoglobin (HbA1C) for diabetic patients(Month 6)
- Presence/absence of comorbidities(Month 6)
- Mortality(Month 6)
- Capillary fasting blood glucose for diabetic patients(Month 6)