Personalised Nutrition for Healthy Living: The PROTEIN Project
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Feasibility of the PROTEIN mobile application's ability to facilitate a lifestyle change
研究概览
简要总结
New advances in information computer technology and artificial intelligence (AI) offer the possibility to create a personalized tool and support system for healthy living and eating, and this is the principal objective of the PROTEIN Project (an EU-funded consortium; Horizon 2020). In order to obtain information on the acceptability, usability and its effectiveness at facilitating behaviour change of the application within the home and store. A pilot trial will be conducted in participants who are overweight (BMI 25-29.9 kg/m2) and a separate group of participants who consume a low quality diet (low in fruit and vegetable intake) and/or have a nutrition deficiency (specifically iron-deficiency anaemia).
During this study the subjects will be asked to attend the lab (or remotely due to covid restrictions) at the beginning of the study for baseline measurements and instructions on how to use / download the mobile application. Participants will have their anthropometrics measured (including height/ weight/ waist: hip circumference). The PROTEIN application will collect self-reported data from the user, which includes: user profile input, dietary and fluid intake, daily physical activity (such as step count), biochemistry, sleep and chewing (in- meal behaviour). Information on how users will interact with the app, which screens they use, how many log ons and how often data is inputted will also be collected. Throughout the trial, the participants will be contacted via the application or by the researchers to request feedback on their progress and to encourage reporting of any issues.
Health care professionals will also be recruited to test the expert dashboard of the PROTEIN app. Through this system they will be able to provide nutrition/ physical activity advice directly to their patients and input their relevant biochemical results (such as haemoglobin for anaemic patients).
详细描述
During this study the subjects will be asked to visit the lab followed between 4 and 16 weeks usage of the PROTEIN app and then a final lab visit.
In the event that COVID-19 restrictions continue and prevent, or restrict, face-to-face visits a completely remote study protocol will also be developed and used in place of the study below.
- Advertising and Recruitment:
i) General public: Prospective users will be recruited by the University of Surrey via social media (e.g. Facebook and Twitter), posters and flyers in the local area and emails sent to University staff and students. With the permission on the relevant group leaders,' overweight participants will be recruited via local commercial weight loss groups. With the permission of the practice managers recruitment via GP practices will also be undertaken, with practice registers screened by a member of practice staff and information/ invitation letters sent to those who meet the inclusion criteria (no details will be shared with the research team). Flyers will also be distributed to local relevant outpatient clinics, e.g. haematology and dietetic with the permission of the clinic managers.
Participants will also be recruited through health care professionals (HCP) in the local area following identification of suitable HCPs (see below)
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Overweight group:
- •≥ 18 years of age
- •BMI: 25 - 30 kg/m2
- •In good physical health
- •Not a regular user of another nutrition support application (such as MyFitnessPal)
- •Able to provide written informed consent
- •Android Smart Phone/ Tablet user
- •Individuals with poor quality diet
- •deficiencies:
- •≥ 18 years of age
- •Diagnosed iron deficiency
- •In good physical health
- •Not a regular user of another nutrition support application (such as MyFitnessPal)
- •Able to provide written informed consent
- •Android Smart Phone/ Tablet user Individuals with poor quality diet
- •low fruit and vegetable intake:
- •≥ 18 years of age
- •Low fruit and vegetable intakes (< 2-3 portions/ day)
- •In good physical health
- •Not a regular user of another nutrition support application (such as MyFitnessPal)
- •Able to provide written informed consent
- •Android Smart Phone/ Tablet user
- •Health care professionals
- •Registered health care professional; General Practitioner/ Dietitian/ Nutritionist/ Registered Exercise Professionals (REPs) etc who sees clients for assistance with weight management and/ or iron deficiency or diet quality.
- •Willing to trial a new nutrition support application with their patients
- •Android Smart Phone/ Tablet user
排除标准
- •Overweight group:
- •Those who have been diagnosed with cardiovascular disease, type 1 diabetes mellitus or type 2 diabetes mellitus.
- •Currently receiving treatment for long term medical conditions
- •Clinically significant haematological abnormalities or an active malignancy
- •Regular exercisers (more than 150 minutes of moderate exercise per week or > 75 minutes of high intensity exercise)
- •People who are unable to exercise for medical reasons or for whom exercise is otherwise contra-indicated by a health professional
- •People with disordered eating (such as anorexia nervosa etc.)
- •Those who are not be able to provide written consent.
- •Those who are unable to read/write sufficiently to provide consent and complete study materials
- •Individuals with deficiencies and poor-quality diet:
- •Those who have been diagnosed with cardiovascular disease, type 1 diabetes mellitus or type 2 diabetes mellitus.
- •Currently receiving treatment for long term medical conditions.
- •Clinically significant haematological abnormalities or an active malignancy
- •Regular exercisers (more than 150 minutes of moderate exercise per week or > 75 minutes of high intensity exercise)
- •People who are unable to exercise for medical reasons or for whom exercise is otherwise contra-indicated by a health professional
- •People with disordered eating (such as anorexia nervosa etc.)
- •Those who are not be able to provide written consent.
- •Those who are unable to read/write sufficiently to provide consent and complete study materials
- •Health Care Professionals:
- •Not affiliated/ registered health care professional
- •Do not have any clients/ patients that fall into one of the groups above (overweight, iron deficiency or low fruit/ vegetable consumption).
结局指标
主要结局
Feasibility of the PROTEIN mobile application's ability to facilitate a lifestyle change
时间窗: At least 4 weeks
Users will be requested to set up the application on their smartphone / tablet, following this the users will be provided with a suggested plan through the artificial intelligence (AI) system. Users will be asked to log all dietary and fluid intake for 7 days per week into the PROTEIN application suite. Therefore, the primary outcome measure will be the adherence/ compliance to the recommendations suggested by the PROTEIN AI system following up to 4 weeks of usage of the mobile application.
次要结局
- User Satisfaction with the PROTEIN Application(At least 4 weeks)
- Suitability and usability review of the PROTEIN application for Health Care Professionals(At least 4 weeks)
- Shopping acceptability within the application(At least 4 weeks)
- Efficacy of the PROTEIN application to monitor within-meal chewing(At least 4 weeks)