Increased Focus on Protein Intake Among Geriatric Patients During Hospitalization: Serving and Acceptance of Protein Enriched Meals in the Morning and Before Bedtime, as Well as Nutritional Guidance by a Clinical Dietician.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 18
- 试验地点
- 2
- 主要终点
- Protein intake
研究概览
简要总结
Up to approximately 38 (unknown drop-out rate) geriatric patients (at least 65 years old) are recruited from a Geriatric ward at Slagelse Sygehus. After inclusion and baseline measurements, each individual will be randomized into either an intervention or control group arranged in blocks of 8 The intervention group (n≤19) will receive protein enriched snacks/dishes in the morning and late evening, before bedtime. Moreover, upon discharge the intervention group will receive individual dietary counseling focusing on choosing protein-rich foods and on protein rich meals. The control group (n≤19) will receive normal hospital food without enrichment and no dietary counseling at discharge. In both groups the following data will be obtained: recorded protein intake, anthropometric measurements (weight, height, body composition estimated with bioimpedance), functional ability (De Morton Mobility Index (DEMMI) and Barthels ADL-index), hand grip strength, sarkopenic status (SARC-F), quality of life (EQ-5D-3L), length of stay (LOS) and readmissions (within 30 days after discharge). During hospitalization food intake will be registered, as well as 24 hour recall interviews and food frequency questionnaires will be done at follow-up visits.
Assessments will be performed at baseline, on the day of discharge and 4 weeks after discharge (follow up).
The primary outcome is change in protein intake from Baseline to 4 weeks after discharge.
The hypothesis is that serving of individually selected protein enriched snack/dish in the morning and before bedtime during hospitalization results in higher protein intake during hospitalization and that this experience combined with dietary counseling at discharge, results in a higher protein intake at 28 days after discharge. Further, we hypothesize that the increased protein intake will affect functional level, hand grip strength, sarcopenic status and quality of life in geriatric patients and will lead to shorter LOS and fewer readmission frequency.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Investigator, Outcomes Assessor)
盲法说明
Two of the study officials will be masked and therefore responsible for testing the participants at baseline, at discharge and follow-up - and in charge of data processing.
Contrary to the masked officials two non-masked officials are responsible for randomization, serving of meals, diet registration and dietary counseling.
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age: ≥65 år and admitted to the geriatric ward at Slagelse Hospital.
- •Expected length-of-stay, LOS: more than 3 days
- •Normal kidney function. (As long as the kidney values remain stable during the intervention it is deemed safe to take part, as the amount of protein given will not exceed the amount recommended by the Danish authorities.
排除标准
- •Dysphagia
- •Patients exclusively fed by tube/probe or parenteral nutrition.
- •Gastrointestinal problems, that makes normal food intake impossible.
- •People suffering from dementia, deliriousness or severe memory loss
- •Patients abusing alcohol
- •Patients in isolation
- •Terminal patients
- •Patients that do not speak Danish or English
- •Patients suffering from food allergies/intolerances that makes it impossible to accommodate to the protein enriched foods.
结局指标
主要结局
Protein intake
时间窗: Change from baseline up to 6 weeks
Dietary recordings with focus on protein intake are collected during hospitalization and at follow up. The total intake of protein per day is assessed.
次要结局
- Food frequency questionnaire(Up to 6 weeks)
- Change in grib strength(Baseline, up to 8 days, up to 6 weeks)
- De Morton Mobility Index (DEMMI)(Baseline, up to 8 days, up to 6 weeks)
- Barthel ADL-index(Baseline, up to 8 days, up to 6 weeks)
- SARC-F(Baseline, up to 8 days, up to 6 weeks)
- EQ-5D-3L(Baseline, up to 8 days, up to 6 weeks)
- Length of stay (LOS)(Up to 8 days (after baseline))
- Readmission(Up to 6 weeks (after baseline))
- Anthropometric measures(Change from baseline up to 6 weeks)
- Bioimpedance(Up to 2 days and up to 6 weeks)
- 24h recall interview(Up to 6 weeks)
- Nutrition related complications(Up to 8 days and up to 6 weeks.)
研究者
Lars Holm
Associate professor
University of Copenhagen