Personalised Nutrition for Healthy Living: The PROTEIN Project
Trial ID: NCT04829851
Status: COMPLETED
Study type: OBSERVATIONAL
Start date: 2021-10-01
Completion date: 2022-12-30
Sponsor: University of Surrey
Collaborators: European Union
Conditions: Overweight; Nutritional Deficiency; Poor Nutrition; Iron-deficiency
Interventions: PROTEIN Mobile App; Expert Dashboard
Locations: University of Surrey
Countries: United Kingdom
Enrollment: 120
Age range: 18 Years - None
Sex: ALL

Summary:
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).

Eligibility criteria:
Inclusion Criteria:

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

1. 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
2. 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

Exclusion Criteria:

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).

Outcomes:
Feasibility of the PROTEIN mobile application's ability to facilitate a lifestyle change