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The PROTEIN Project

NCT04829851 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 120

Last updated 2023-05-16

No results posted yet for this study

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

Interventions

DEVICE

PROTEIN Mobile App

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.

DEVICE

Expert Dashboard

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.

Sponsors & Collaborators

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-10-01
Primary Completion
2022-11-04
Completion
2022-12-30

Countries

  • United Kingdom

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04829851 on ClinicalTrials.gov