The PROTEIN Project

NCT04829851 | Completed

• 1 other identifier: PROTEIN
• Study Type: observational
• Target: 120
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Overweight; Nutritional Deficiency; Poor Nutrition; Iron-deficiency

Outcome Measures

Primary Outcomes (1)

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

  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.

  At least 4 weeks

Secondary Outcomes (4)

• Shopping acceptability within the application

  At least 4 weeks

• Efficacy of the PROTEIN application to monitor within-meal chewing

  At least 4 weeks

• 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

Study Arms (4)

Health Care Professionals

Registered health care professional, such as a General Practitioner/ Dietitian/ Nutritionist/ Registered Exercise Professional (REPs) etc. who sees clients for assistance with weight management and / or iron deficiency or diet quality.

Device: Expert Dashboard

Adults who are Overweight

Adults (\> 18 years) who are considered to be overweight (25 - 30 kg/m2) but are otherwise in good physical health and a regular android smart phone/ tablet user.

Device: PROTEIN Mobile App

Adults with Iron Deficiency Anaemia

Adults (\> 18 years) who have been diagnosed with Iron deficiency anaemia but are otherwise in good physical health and a regular android smart phone/ tablet user.

Device: PROTEIN Mobile App

Adults with Low- Fruit/ Vegetable Intake

Adults ( \> 18 years) with a low fruit and vegetable intake (2-3 portions/ d) but are otherwise in good physical health and a regular android smart phone/ tablet user.

Device: PROTEIN Mobile App

Interventions

PROTEIN Mobile App DEVICE

All recruited user groups will be expected to use the PROTEIN app. During this study the subjects will be asked to visit the lab followed by at least 4 weeks usage of the PROTEIN app and then a final lab visit.

Adults who are Overweight; Adults with Iron Deficiency Anaemia; Adults with Low- Fruit/ Vegetable Intake

Expert Dashboard DEVICE

Health care professionals (HCP) will be contacted via email and will also be invited to either attend the lab or meet with the researchers utilizing Zoom/ Microsoft teams to discuss the usage of the expert dashboard within the PROTEIN application.

Health Care Professionals

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

General public within the local area (Surrey, UK)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Surrey: lead
• European Union: collaborator

Study Sites (1)

University of Surrey

Guildford, GU27XH, United Kingdom

Location

MeSH Terms

Conditions

Overweight; Malnutrition; Anemia, Iron-Deficiency

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Anemia, Hypochromic; Anemia; Hematologic Diseases; Hemic and Lymphatic Diseases; Iron Deficiencies; Iron Metabolism Disorders; Metabolic Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 25, 2021
• First Posted: April 2, 2021
• Study Start: October 1, 2021
• Primary Completion: November 4, 2022
• Study Completion: December 30, 2022
• Last Updated: May 16, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)