The Impact of Preoperative FoodforCare at Home on Nutritional and Functional Outcomes
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 126
- 试验地点
- 2
- 主要终点
- Protein intake relative to requirements
研究概览
简要总结
Preoperative nutritional state is closely related to perioperative morbidity and complications. This study aims to determine the effect of a protein-rich meal service in the preoperative setting compared to usual care.
详细描述
Each year, approximately 1.4 million patients in the Netherlands are operated. Adequate nutritional intake, mainly protein intake, before surgery is important to improve preoperative muscle strength and functional capacity. However, up to 40% of patients admitted to the hospital suffer from malnutrition and this further deepened during hospitalization, which is an independent risk factor for peri-operative morbidity and severe complications, ranging from increased muscle loss, to higher infection rates, delayed wound healing and subsequently a prolonged hospital stay. An adequate food service is one strategy to improve protein intake and thereby the nutritional status. Extension of the study period to the out-of-hospital setting is recommended to explore the effects of long-term exposure to this concept on nutritional, functional and clinical outcomes. Therefore, the investigators aim to evaluate whether home delivered protein-rich meals, as part of FoodforCare meal service, in the preoperative setting improves protein intake in patients undergoing surgery, compared to usual care. The second aim is to investigate the effects on functional and clinical outcomes.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18 years or older
- •surgical patients
- •living within a 40 km radius around Nijmegen/Veghel
- •inclusion at least 4 weeks before surgery
- •surgery: Urology, Orthopedics, Gynaecology, General Surgery
- •oral intake
排除标准
- •renal insufficiency (MDRD-GFR (glomerular filtration rate) < 60ml/min and/or proteinuria)*
- •food allergy
- •planned vacation during intervention period
- •proteinuria is defined in case of a protein creatinine ratio > 0.5g/10mmol or an albuminuria > 300mg/day.
研究组 & 干预措施
Intervention group
The intervention group will receive meals from FoodforCare at Home. The FoodforCare at Home concept consists of six small protein and energy enriched meals and snacks that will be delivered twice a week. After an individual intake, the composition of the dishes will be tailored to the needs of the patient in terms of composition, diet, taste, flavor and portion size. Besides the meals, patients in the intervention group will also receive an information leaflet about the importance of protein during treatment and how to reach their protein requirements.
干预措施: FoodforCare at home (Other)
Control group
The control group will continue their usual diet for 3 weeks and have no restrictions to their diet.
结局指标
主要结局
Protein intake relative to requirements
时间窗: 3 weeks
3-day food diary filled in at baseline and after 3 weeks.
次要结局
- Muscle strength(3 weeks)
- Nutritional status(3 weeks)
- Length of stay(2 months)
- Quality of life and overall health status(3 weeks)
- Patient satisfaction(3 weeks)
- Readmissions(2 months)
- Postoperative complications(2 months)
- Energy intake relative to requirements(3 weeks)
- Functional status(3 weeks)