Personalised Nutrition for Healthy Living: PROTEIN
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 27
- 试验地点
- 2
- 主要终点
- Improve eating behavior towards healthier choices
研究概览
简要总结
The topic of diet and physical activity are of great importance in the treatment of T2D. In the daily routine of a practice or clinic, a doctor has an average of eight minutes per patient, leaving little time for lifestyle issues (Irving et al. 2017). An individualised procedure requires more time and therefore more resources. Currently, an app can be programmed with evidence-based information so that it provides appropriate personalised behavioural recommendations via machine learning. The user gets direct feedback and can make a behavioural change himself. On the one hand, this approach allows better use of doctor-patient time and, on the other hand, the patient learns through positive reinforcement in such a way that his or her behaviour change is supported and reinforced in the longer term and potentially sustainably.
The aim of this intervention pilot study within the scope of the EU-Horizon 2020 project is to investigate lifestyle support through a mobile app and wearables to improve lifestyle (personalised nutrition) and important metabolic outcomes in patients with type 2 diabetes or prediabetes. In addition, exploratory genetic and microbiome data will be explored to answer the question of personalisation of the recommendations.
详细描述
An inadequate diet and increasing sedentary lifestyle are major contributors to the rise of non-communicable diseases. Individualized recommendations can lead to a healthier lifestyle. The scientific evidence of the effectiveness of health apps offering personalized recommendations is limited.
The aim of this intervention pilot study within the scope of the EU-Horizon 2020 project is to investigate lifestyle support through a mobile app and wearables to improve lifestyle (personalised nutrition) and important metabolic outcomes in patients with type 2 diabetes or prediabetes. The Investigators want to asess whether the use of this mobile application that incorporates information of wearables (continuous glucose monitoring and fitness tracker), improves lifestyle and metabolic outcomes in patients with type 2 diabetes (T2D) or prediabetes. Our primary outcome is to improve time in range (TIR) by 5%.
It is a prospective randomized control pilot trial with an intervention period of 12 weeks. Participants will use the Protein app, a continuous glucose monitoring system (CGM) and an activity tracker to collect real world data to enable personalisation.
In order to identify the effect of the PROTEIN-Application, 300 participants with T2DM or prediabetes will be randomly allocated into two groups: the (1) start-group or the (2) wait-group. The start-group will use an activity tracker, a CGM and the PROTEIN app for 12 weeks followed by a six-week period without the app, but they will use the wearables. The wait-group will use an activity tracker and a CGM, but not the PROTEIN app for six weeks followed by a period of 12 weeks using the PROTEIN app. This study design allowed us to have a control group within the whole cohort and clearly see the influence of the PROTEIN app.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 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
- •≥ 18 years of age
- •Diabetes Type 2 or Prediabetes
- •BMI: 20-kg kg/m2
- •Android Smart Phone/ Tablet use
- •In good physical health
- •Able to provide written informed consent
排除标准
- •Severe endocrine, gastrointestinal, metabolic, cardiovascular, pulmonary, inflammatory or psychiatric disorder
- •Active or recent relevant cancer
- •Currently receiving treatment with Insulin
- •People with disordered eating (such as anorexia nervosa etc.)
- •Those who are not be able to provide written consent
研究组 & 干预措施
Start-Group
The Start-Group starts with the Protein-Application and wereables for 3 Months and afterwards uses only wereables for 6 Weeks.
干预措施: Usage of the PROTEIN-Application (Other)
Wait-Group
The Wait-Group starts with 6 Weeks of using only wereables and afterwards adds the usage of the Protein-Application.
干预措施: Usage of the PROTEIN-Application (Other)
结局指标
主要结局
Improve eating behavior towards healthier choices
时间窗: 12 Weeks
Improve eating behaviour towards healthier choices during the intervention time
Improvement of Time In Range (TIR) by 5%
时间窗: 12 Weeks
Our primary objective is to increase the time in range (TIR) of the study participants by 5%
次要结局
- Reduction in sedentary time(12 Weeks)
- Measurable change in the faecal microbiome(12 Weeks)
- Calculation of the Polygenic Risk Score(12 Weeks)
- Adherence to dietary recommendations of the app(12 Weeks)
- Improvement of glycaemic metabolism(12 Weeks)
- Aproximation of the energy intake(12 Weeks)
研究者
Prof. Dr. med. Andreas F. H. Pfeiffer
Principal Investigator, Univ. Prof. Dr. med.
Charite University, Berlin, Germany