Impact on Energy Intake by Implementing Recommended Food Texture Through Dietary Guidance at the Department of Swallowing and Eating Disorders; a Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 13
- 试验地点
- 2
- 主要终点
- Changes in energy intake, from baseline.
研究概览
简要总结
An intervention study on the effect of dietary guidance with focus on implementing recommended food texture, at the department of Eating and Swallowing difficulties, Region Midtjylland, Denmark.
Energy- and protein intake, Weightloss, Bodymass composition, Fluid balance and Activities of Daily Living (ADL), will be measured by Bioimpedance spectroscopy, interviews and a questionnaire.
详细描述
It is know that people with eating- and swallowing difficulties(known as dysphagia), is prone to weightloss due to insufficient energy- and protein intake, and a reduction in ADL.
ADL will in this project have its focus on the eating situation.
The projects research questions are:
- Will dietary guidance with texture implementation increase energy intake in patients being examined on an outpatient basis for dysphagia, based on the Fiberoptic Endoscopic Evaluation of Swallowing (FEES) recommendation?
- Can a dietetic guidance with texture implementation increase quality of life and ADL in patients with dysphagia?
Recruitment and data collection will take place at Hammel Neurocenter, DK.
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 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Signed consent form
- •Newly refered patients to FEES examination
- •Score 1-4 on FEDSS-scale
- •Consumes 50% energy or more orally
- •Consumes less energy than calculated energy need (Harris-Benedict)
- •Individuals of full legal capacity
- •Individuals above 18 of years
- •That the patient is capable of executing examinations
排除标准
- •Individuals with known eating disorders
- •Ineligible individuals
- •Individual in need of translator
- •Individuals participating in another trial
结局指标
主要结局
Changes in energy intake, from baseline.
时间窗: Eight weeks
Change in energy intake, measured from baseline. Measured in kilojoule by a standardized interview with examples of pictures to determine serving size.
次要结局
- Fat Mass.(Eight weeks)
- Lean Body Mass.(Eight weeks)
- Compliance of recommended changes.(Eight weeks)
- Changes in Dysphagia Handicap Index (DHI) total and section (E and F) score.(Eight weeks)
- Changes in protein intake.(Eight weeks)
- In how many questions in the DHI, does the intervention group change the score in relation to the control group, and with how much.(Eight weeks)
- Fluid Balance.(Eight weeks)
- Body Weight.(Eight weeks)