Diet Intervention Study Through Telemedicine Assistance on SNAS Patients in COVID-19 Pandemic
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Dietary assessment
研究概览
简要总结
Restrictions due to Covid-19 pandemic have brought negative social and psychological consequences on people and limited patients' access to hospital care.
In this context, "telemedicine" and, specifically, "tele-nutrition" (in nutritional field) allows remotely monitor and support food allergic patients subjected to restricted diets using information and communication technologies.
The investigators focus attention on patients with diagnosis of Systemic Nickel Allergic Syndrome (SNAS) undergoing low-nickel diet to evaluate nutritional and psychological states through tele-nutrition tools during COVID-19 pandemic.
The aims of this study are: (a) to investigate dietary-nutritional status and, (b) to assess quality of life and adherence to dietary therapy before and after 30-day personalized diet therapy through tele-nutrition tools.
Each subject enrolled in the study goes allergological work-up to assess diagnosis of SNAS and following procedures: (a) face-to-face visit (nutritional visit and quality of life evaluation) concluding with prescription of one of five personalized and balanced dietary plans different for calory intake, (b) video call visit for dietary evaluation and assessment of adherence to diet after 15 days, and (c) video call visit for dietary and quality of life evaluation and assessment of adherence to diet therapy after 30 days (end of study).
详细描述
There are no previous studies focused on the tele-nutrition for the evaluation of dietary-nutritional status of patients suffered from Systemic Nickel Allergic Syndrome (SNAS).
The aims of this study are (a) to investigate dietary-nutritional status (primary outcome) and, (b) to assess quality of life (QoL) and adherence to dietary therapy (secondary outcomes) of SNAS patients before and after personalized diet therapy through tele-nutrition tools at time of COVID-19 pandemic.
The investigators perform a prospective, single-center, observational study enrolling SNAS patients in order to evaluate dietary-nutritional status and QoL, before and after 30-day personalized diet therapy, and adherence to low Ni diet, through tele-nutrition tools, during COVID-19 pandemic.
The study is performed at the Allergology Unit and Dietetics and Clinical Nutrition Unit of Fondazione Policlinico Universitario A. Gemelli IRCCS in Rome, Italy.
All enrolled patients give their signed informed consent to participation in the study.
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
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •history of SNAS (coexistence of typical cutaneous and gastrointestinal symptoms);
- •positive Ni-patch test;
- •clinical improvement of at least 70% from baseline after 4 weeks of low-Ni diet;
- •positivity of a double-blind placebo-controlled oral Ni challenge (DBPCO).
排除标准
- •age < 18 years and >65 years;
- •other organic gastrointestinal diseases, such as peptic ulcer, inflammatory bowel diseases, celiac disease, gastrointestinal infections, and small intestinal bacterial overgrowth;
- •diabetes mellitus;
- •hepatic, renal or cardiac dysfunction;
- •thyroid disease or tumour;
- •concomitant treatment with steroids and/or antihistamines in the previous 4 weeks;
- •pregnancy and lactation;
- •smoking, abuse of alcohol, coffee, tea, and cola intake;
- •inability to give written informed consent.
结局指标
主要结局
Dietary assessment
时间窗: At enrollment
Dietary assessment includes questionnaire on 1) drinking alcohol, 2) particular diet (such as vegetarian, vegan or raw food), 3) number of meals per day, 4) same time for meals, 5) place of lunch on non-holiday, 6) frequency of eat away from home (times per week), 7) water intake, and 8) frequency of consumption of foods (desserts, processed meat, red meat, eggs, legumes, milk and derivatives, white meat, bread/pasta/rice, fish fruit and vegetable).
Change of body mass index (BMI)
时间窗: Change from Baseline BMI at 15 and 30 days
Collection of weight in kilograms and height in meters will be combined to report BMI in kg/m\^2.
Change of circumference of waist
时间窗: Change from Baseline circumference of waist at 15 and 30 days
Collection of anthropometric data: circumference of waist in centimeters.
Change of circumference of wrist
时间窗: Change from Baseline circumference of wrist at 15 and 30 days
Collection of anthropometric data: circumference of wrist in centimeters.
Change of circumference of hip
时间窗: Change from Baseline circumference of hip at 15 and 30 days
Collection of anthropometric data: circumference of hip in centimeters.
Change of circumference of arm
时间窗: Change from Baseline circumference of arm at 15 and 30 days
Collection of anthropometric data: circumference of arm in centimeters.
次要结局
- Adherence to dietary therapy(After 15 days, after 30 days)
- State of well-being(At enrollment, after 30 days)
研究者
Eleonora Nucera
Head of Allergy Unit
Catholic University of the Sacred Heart