Electronic-Nutrition-Optimizer for Personalized Prevention
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 88
- 试验地点
- 2
- 主要终点
- Perception questionnaire using system usability scale
研究概览
简要总结
This study aims to develop and validate a tool for immediate nutrition assessment and to test its user feasibility in routine clinical practice for health promotion.
详细描述
Small changes in diet have been shown to have an important impact on health and the risk of age-related chronic diseases, such as cardiovascular disease, diabetes, frailty and dementia. However, this knowledge has not yet been implemented into routine clinical practice, because practical tools that allow a comprehensive nutrition assessment in the clinical care setting are missing. In addition, doctors are generally not educated in giving nutritional advice to patients. In this pilot project, we aim to push forward and enable the potential of nutrition as a core primary prevention strategy for people at risk of developing chronic diseases. This will be achieved by using, as a stepping stone, the electronic 216-food-item food frequency questionnaire which was developed for the European DO-HEALTH study and was tested in over 2000 adults. The investigators want to extend this tool to not only capture the personal dietary intake, but also to produce an immediate report, comparing the personal diet to the Mediterranean and MIND diet patterns and providing a patient's intake of protein and other nutrients. The report will additionally indicate the patient's diet-related, personalized risks of cardio-vascular disease, diabetes, frailty and cognitive decline, and recommend dietary changes to reduce these risks.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Crossover
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Stable inpatients from the Department of heart surgery, or Center for senior trauma patient at the university hospital Zurich (inpatient group)
- •Ambulatory volunteers who can visit the center for aging and mobility (CAM) independently ("outpatients" group)
排除标准
- •If already involved in another ongoing interventional clinical trial, except an interaction with this intervention can be excluded
- •People with an impaired short-term memory (MMSE <24)
- •Patients following a specific diet recommended by a medical professional, due to diseases such as diabetes, chronic diseases of the gastrointestinal tract, severe kidney disease, or patients allergic to the main components of the Mediterranean diet/MINDdiet (olive oil, nuts)
- •Outpatients: HbA1C ≥6.5% Inpatients: HbA1C ≥6.5% or diagnosed diabetes mellitus if HbA1C is not available in KISIM
- •BMI > 30 kg/m2
- •Individuals per se not willing to change diet
- •Instable clinical conditions (e.g. acute infection) at enrolment
- •Patients with active cancer (except non-melanoma skin cancer) or current cancer treatment or any other advanced severe disease
- •Living in a nursing home and/or receiving prepared meals (i.e. usually not eating home cooked meals)
- •Inability to read and or speak German necessary to understand the instructions
结局指标
主要结局
Perception questionnaire using system usability scale
时间窗: Baseline
Feasibility Study (in- and outpatient group) Scale from 1 to 5, indicating 1 "not true", 5 "very true"
Subjective effectiveness questionnaire of eNutrition Optimizer
时间窗: month 3 to 6
Feasibility Study (in- and outpatient group) Scale from 1 to 5, indicating 1 "not true", 5 "very true"
次要结局
- waist-to-hip ratio(6 months)
- systolic and diastolic blood pressure(6 months)
- blood marker Non-HDL cholesterol (mmol/l)(6 months)
- BMI(6 months)
- blood marker HbA1C (%)(6 months)
- blood marker Folate (µg/l)(6 months)
- blood marker Iron (µmol/l)(6 months)
- blood marker Soluble transferrin receptor (mg/l)(6 months)
- blood marker Vitamin B12 (ng/l)(6 months)
- blood marker Ferritin (µg/l)(6 months)
- 24h diet recalls(month 4 to 6)
- blood marker Triglycerides (mmol/l)(6 months)
- blood marker Fasting glucose (mmol/l)(6 months)
- blood marker Interleukin-6 (pg/ml)(6 months)
- Dietary patterns assessed with the eNutrition Optimizer (based on a food frequency questionnaire), MIND diet score ranging from 0 to 15 with 0=worst, 15=best ; Med Diet score ranging from 0 to 55 with 0=worst, 15=best(6 months)
- blood marker HDL cholesterol (mmol/l)(6 months)
- blood marker Transferrin (µmol/l)(6 months)
- blood marker high sensitive-CRP (mg/l)(6 months)
研究者
Heike Bischoff-Ferrari
Director, Geriatric Clinic, University Hospital Zurich
University of Zurich