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临床试验/NCT03176030
NCT03176030撤回不适用

Can Fortified Foods Improve Energy and Protein Intake in Older People Whilst in Hospital? A Pilot Study

University Hospital Southampton NHS Foundation Trust1 个研究点 分布在 1 个国家开始时间: 2017年9月1日最近更新:
适应症

试验速览

阶段
不适用
状态
撤回
试验地点
1
主要终点
Daily energy and protein intake

研究概览

简要总结

Malnutrition in older inpatients is a significant problem espicially among those with dementia. A number of methods have been used to tackle this issue and oral nutritional supplements (ONS) were proven to be the most effective way. However, they are limited by their poor tolerability due to lack of familiarity with these products. An alternative method is to fortify familiar food with protein, energy and micronutrient. thus, the aim of this study to test the feasibility and acceptability of delivering fortified foods to older patients whilst in hospital including those with dementia and frailty. This pilot study will compare the daily protein and energy intake in older people before and after offering fortified food. Furthermore, patients' likeability and staff acceptability of these fortified foods will be assessed.

详细描述

Malnutrition is a significant problem amongst hospitalised older people, and can impede effective recovery. Oral nutritional supplements (ONS) are limited by their poor tolerability and an alternative strategy is food fortification, the addition of protein/energy/micronutrients to frequently eaten food. The aim of this pilot study is to establish the feasibility and acceptability of delivering fortified foods to older people including those who have dementia and frailty whilst in hospital and to assess whether fortified foods could increase the energy and protein intake.

This is a quasi-experimental study on acute medical wards for older inpatient in two UK hospitals, with a before and after comparison. The intervention involves the provision of additional between-meal fortified foods (enhanced with protein, energy, and micronutrients) and meal supplementation. Daily energy and protein intake will be assessed for three consecutive days during the baseline period and then in the intervention period. Likeability of fortified food and food choices (the number, type, and frequency of fortified foods consumed) will be examined. Likeability of fortified food by patients will be assessed using likeability scales. Interviews or focus groups will be conducted with staff to assess the acceptability of fortified food. Costs related to developing, packing and delivering the fortified foods will be calculated.

The findings of this pilot study will identify whether delivering fortified food is feasible in acute elderly care wards, which foods are preferred and their acceptability. The results will inform the design of a definitive clinical trial.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
70 Years 至 100 Years(Older Adult)
性别
All
接受健康志愿者

入选标准

  • Both female and male participants in each hospital.
  • Patients aged 70 years and above including those who have dementia and frailty.

排除标准

  • Patients receiving enteral tube feeding or parenteral nutrition
  • Patients with a known food allergy, eating disorder or illness, which requires a therapeutic diet incompatible with fortification.
  • Patients who are receiving end of life care.

结局指标

主要结局

Daily energy and protein intake

时间窗: 3 consecutive months

Daily dietary intake will be assessed on three days during both the baseline and intervention periods using visual assessment. each food or meal will be weighed before serving and once the patient has finished using calibrated scales. In addition, a photograph of each plate of food will be taken before and after consumption for each eligible patient. At the end of each meal, the proportion of uneaten (leftover) food will be recorded in quartiles (0%, 25%, 50%, 75%, or 100%) for each component

Patient's likeability of fortified foods

时间窗: 3 days intervention period

A 9-point likeability scale will be completed for each eligible patient to test likeability of fortified foods after each meal or snack time during the intervention period.

Feasibility of delivering fortified foods

时间窗: 3 days intervention period

The number, type, and frequency of fortified foods chosen by eligible patients during the intervention period will be recorded. This will be done by using a food chart with images. Thus data will be collected on the type of foods (ice-creams, biscuits, soups or cakes) chosen, flavors preferred by individual patients initially and repeat choices, the number of foods chosen each time and at which time of the day.

次要结局

  • Acceptability of fortified food(within 4 weeks of completing the intervention)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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