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临床试验/NCT03133364
NCT03133364已完成不适用

Developing and Testing Delicious and Nutritious for the Old People

University of Copenhagen1 个研究点 分布在 1 个国家目标入组 52 人开始时间: 2017年5月17日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
52
试验地点
1
主要终点
Health related quality of life (EQ-5D-3L)

研究概览

简要总结

Meals-on wheels may play a major role in contributing to better nourishment and quality of life in older people, thus delaying costly hospitalisation. Still, dwelling, old adults who receive meals-on-wheels are a population at risk of undernutrition leading to a decreased quality of life.

Hypothesis Offering nutritious ELDORADO meals as meals-on-wheels to nursing home residents in 3 months is an effective way to increase quality of life.

Aim To improve quality of life and functional abilities in nursing home residents by offering nutritious ELDORADO meals.

详细描述

Intervention The intervention group (n=50) will receive an optimized menu (in both sensory and nutritious aspects) for 12 weeks. In cooperation with the Copenhagen house of food and sensory staff, 19 main meals and 12 between-meals have been optimized based on nursing home residents' evaluations of sensory aspects. On a daily basis the menu will consist of 1 optimized main meal and 1 optimized between-meal, served for dinner. There will be no selective choice for the elderly. If a participant does not want the daily meal, he will receive another meal from the ordinary menu from the kitchen.

Control In comparison, the control group (n=50) will receive the same menu as the intervention group, however, the meals are not optimized on sensory and nutritious aspects. On a daily basis this menu also includes 1 main meal and 1 between-meal in 12 weeks. If a participant does not want the daily meal, he will receive another meal from the ordinary menu from the kitchen.

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
Triple (Participant, Care Provider, Investigator)

盲法说明

Participants are randomized to the control group (C) and intervention group (I) using the programme "Research randomizer". The main supervisor will manage the randomization.

Participants are blinded to whether they receive the control or intervention menu. Each menu will daily consist of a main meal and a between-meal.

入排标准

年龄范围
65 Years 至 —(Older Adult)
性别
All
接受健康志愿者
是

入选标准

  • •Living at Skovhuset, nursing home in Hillerød municipality, Denmark.
  • •Collecting the "energy-dense diet" "ældrekost" with 40 % fat, with a main meal and a dessert/starter.
  • •Able to understand and follow instructions for the procedures of the study.
  • •Above 65 years.

排除标准

  • •Have chewing or swallowing difficulties.
  • •Have acute disease or acute change in chronic disease.
  • •Living after special nutritional standards e.g. vegetarian, have any food allergies, or if a participant is excluding common foods from their diet because of other reasons.
  • •Not able or willing to give informed consent.

研究组 & 干预措施

Sensory optimized meals

Active Comparator

Intervention group is receiving:

Popular dishes selected from hospital and meal service menus optimized by sensory experts. Optimization is done with respect to taste, texture and appereance and on nutritional composition of the meals with focus on protein content.

干预措施: Sensory optimized meals (Other)

Control

Placebo Comparator

Control group is receiving:

Popular dishes selected from hospital and meal service menus, NOT optimized by sensory experts.

干预措施: Sensory optimized meals (Other)

结局指标

主要结局

Health related quality of life (EQ-5D-3L)

时间窗: 12 weeks

(EQ-5D-3L) is a standardized instrument for use as a measure of health outcome. The EQ-5D-3L descriptive system comprises the following 5 dimensions (5D): mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 3 levels (3L): no problems (1 point), some problems (2 points), extreme problems (3 points). This gives a total of 245 different health states, adding unconscious and dead.

次要结局

  • MMSE (mini mental status)(12 weeks)
  • Height(12 weeks)
  • Chair stand(12 weeks)
  • EVS(12 weeks)
  • Liking(One month in the middle of the intervention)
  • Compliance(12 weeks)
  • Hand grip strenght(12 weeks)
  • Diet registration(4 days)
  • Satisfaction with food related life (SWFL)(12 weeks)
  • Observations of meals(One month in the middle of the intervention)
  • Weight(12 weeks)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Arne Astrup

Head of institute (Nutrition Exercise and Sports)

University of Copenhagen

研究点 (1)

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