Specialist Dietetic Intervention in Malnourished Patients with Fibrotic ILD: a Randomised Controlled Pilot Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Recruitment rate
研究概览
简要总结
Malnutrition occurs when the body receives too few nutrients, resulting in health problems such as weight loss. The consequences of malnutrition are worrying as they include lung failure, infection, and pressure ulcers.
Interstitial Lung Disease (ILD) is a term used for a group of diseases which can cause scarring of the lungs. Having ILD can cause malnutrition due to the lungs working hard and burning off energy. Additionally, medications called anti-fibrotic agents are used to slow disease progression. However, side effects include poor appetite, diarrhoea, nausea, vomiting and weight loss which can result in malnutrition.
Malnutrition occurs in ILD in approximately half of patients. This is important because the main signs of malnutrition such as weight loss and a low Body Mass Index (BMI), which takes into consideration your weight against your height, are linked with worse outcomes in ILD. Malnutrition in ILD can also reduce eligibility for lung transplant and can impact tolerability of anti-fibrotic agents. Research into treatment of malnutrition in ILD is limited.
Dietitians play a key role in diagnosis and treatment of malnutrition. This is because dietary counselling by a dietitian has been shown to increase quality of life and intake of energy in other chronic diseases. There are currently no studies documenting the benefits of dietetic intervention in patients with ILD.
We propose to undertake the first feasibility study in this area. A feasibility study is a first step trial which investigates whether a study can & should be done. The main aims of this study are:
- How easy it is to recruit ILD patients to see a dietitian
- Whether patients will attend dietetic appointments
- Whether food/nutrient intake is increased following dietetic intervention
- How acceptable is dietetic intervention to ILD patients As well as these main aims, this study will also provide initial information about whether dietetic intervention stabilises weight, BMI & quality of life.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 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
- •BMI ≤ 20kg/m2, or if aged >75, BMI ≤ 21 (Righini et al., 2013)
- •Over the past 12 months, unintentional weight loss ≥ 5% of body weight, regardless of baseline BMI or weight loss >2 kg if BMI is normal.
排除标准
- •Co-morbidities currently requiring a specialised diet (including enteral feeding)
- •End of life care (estimated less than 6 weeks left to live)
- •Expected introduction of anti-fibrotic or immunosuppressive treatment or introduction/increase corticosteroid dose during trial period
- •Pregnancy
- •Unable to give consent
研究组 & 干预措施
Individualised dietetic advice
Participants will receive 5 sessions receiving individualised nutritional counselling advice from a registered dietitian.
干预措施: Dietetic intervention (Other)
Diet sheet
Participants will receive a diet sheet around poor appetite.
干预措施: Diet sheet (placebo) (Other)
结局指标
主要结局
Recruitment rate
时间窗: 8 months
Number individuals recruited/Number individuals contacted
Compliance
时间窗: Defined by increased energy & protein intake versus run-in (three-day diet-diaries).
3 months
Completion rate
时间窗: 3 months
Number individuals completing study/Number individuals randomised
次要结局
- Nutritional status (Malnutrition)(3 months)
- Nutritional status (gastrointestinal related symptoms)(3 months)
- Anthropometrics (weight)(3 months)
- Anthropometrics (height)(3 months)
- Anthropometrics (Body Mass Index)(3 months)
- Handgrip strength(3 months)
- Quality of Life (QoL)(3 months)
- Energy and Protein intake(3 months)