The PROTEIN Project

• Research type

  Research Study

• Full title

  PeRsOnalised nuTrition for HEalthy LivINg: The PROTEIN Project

• IRAS ID

  294871

• Contact name

  Kathryn Hart

• Contact email

  k.hart@surrey.ac.uk

• Sponsor organisation

  University of Surrey

• Clinicaltrials.gov Identifier

  NCT04829851

• Duration of Study in the UK

  1 years, 0 months, 1 days

• Research 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).

  Lay Summary of Results:

  80 participants provided baseline data (380 screened, 190 eligible). Recruitment was delayed and curtailed due to the COVID-19 pandemic and to delays in the development of the mobile application.
  Participants were classified as i) Poor quality diet (low fruit and vegetables) (n=29), ii) iron deficiency anaemia (n=11), iii) overweight (n=40). 58% were female and the group had a mean age of 44.7 [16.1] years and a mean BMI of 27.7[5.5]kg/m2.
  63 completed follow up (79% retention). There were no significant changes in weight over the study, although the overweight group had the largest reduction (a non-significant weight loss of -1.4[1.4]kg).
  The system was able to recommend meals that were in line with the appropriate nutritional recommendations for each group, with mean nutrient levels being within range for all except protein (above range) and energy (below range) for the iron deficiency/ poor quality diet group ONLY.
  There was low user engagement with the mobile app. Between 94 and 97% of all meals were not confirmed as consumed or skipped by the user. The greatest interaction was in the morning (breakfast and morning snack were most likely to be recorded) but reduced over the day.
  Participants reported an increased motivation and ability to eat healthily after using the app. (40% and 51% respectively agreeing or strongly agreeing that ability/ motivation had increased). Responses to the validated System Usability Scale suggested low usability across the groups - mean score 48.5/100 for users who were overweight and 45.5/100 for poor quality diet/ iron deficiency users (benchmark for 'acceptable' usability would be at least 70/100). This appeared to be mainly related to the system being complex and cumbersome to use.

  Overall:
  - The PROTEIN app could accurately define appropriate meal plans BUT more meal plans are needed for those with more specific needs/ restrictive diets to increase meal variety
  - The PROTEIN app could motivate users to improve their lifestyle BUT substantial improvements to user experience are required to maximise the impact of the app and the positive attitudes fostered and promote greater engagement with the technology.
  - Future versions of the mobile app should focus on developing a more user-friendly system to increase interaction.

  Has the registry been updated to include summary results?: Yes
  If yes - please enter the URL to summary results: https://gbr01.safelinks.protection.outlook.com/?url=https%3A%2F%2Ftrack.pstmrk.it%2F3ts%2Fclinicaltrials.gov%252Fstudy%252FNCT04829851%253Flat%253D51.2622513%2526lng%253D-0.4672517%2526locStr%253DSurrey%252C%252520UK%2526distance%253D50%2526term%253Dpersonalized%2526intr%253Dnutrition%2526rank%253D6%2526tab%253Dresults%2FNBTI%2F7XW-AQ%2FAQ%2F9ea66b90-284f-490c-a6ab-f1ee56610990%2F1%2FYqGChnIjpG&data=05%7C02%7Csurreyborders.rec%40hra.nhs.uk%7Ccc94316d553f445490d408dddf0a0972%7C8e1f0acad87d4f20939e36243d574267%7C0%7C0%7C638911956383810265%7CUnknown%7CTWFpbGZsb3d8eyJFbXB0eU1hcGkiOnRydWUsIlYiOiIwLjAuMDAwMCIsIlAiOiJXaW4zMiIsIkFOIjoiTWFpbCIsIldUIjoyfQ%3D%3D%7C0%7C%7C%7C&sdata=hYYJG7RHjQOz2%2FFh36AHM18qq6VuDiPoLs7s3Wc7ezY%3D&reserved=0
  If no – why not?:
  Did you follow your dissemination plan submitted in the IRAS application form (Q A51)?: Yes
  If yes, describe or provide URLs to disseminated materials: Papers published including:
  - Patra E & PROTEIN team (2024) Personal goals, user engagement, and meal adherence within a personalized AI-based mobile application for nutrition and physical activity. Life. https://gbr01.safelinks.protection.outlook.com/?url=https%3A%2F%2Ftrack.pstmrk.it%2F3ts%2Fwww.mdpi.com%252F2075-1729%252F14%252F10%252F1238%2FNBTI%2F7XW-AQ%2FAQ%2F9ea66b90-284f-490c-a6ab-f1ee56610990%2F2%2FUaCJZuB3zi&data=05%7C02%7Csurreyborders.rec%40hra.nhs.uk%7Ccc94316d553f445490d408dddf0a0972%7C8e1f0acad87d4f20939e36243d574267%7C0%7C0%7C638911956383840236%7CUnknown%7CTWFpbGZsb3d8eyJFbXB0eU1hcGkiOnRydWUsIlYiOiIwLjAuMDAwMCIsIlAiOiJXaW4zMiIsIkFOIjoiTWFpbCIsIldUIjoyfQ%3D%3D%7C0%7C%7C%7C&sdata=oOozbkHavFDOkAphTtfF%2BCQ7SNuNpsm4gwrqRzTpfUs%3D&reserved=0
  - Wilson-Barnes, S.L., Pagkalos, I., Patra, E., Lanham-New, S.A., Hart, K. (2024) The development of an EU-wide nutrition and physical activity expert knowledge base to support a personalised mobile application across various EU population groups. Nutrition Bulletin. 49(2), pp. 220–234. https://gbr01.safelinks.protection.outlook.com/?url=https%3A%2F%2Ftrack.pstmrk.it%2F3ts%2Fpubmed.ncbi.nlm.nih.gov%252F38773712%252F%2FNBTI%2F7XW-AQ%2FAQ%2F9ea66b90-284f-490c-a6ab-f1ee56610990%2F3%2FI0sqYndSQP&data=05%7C02%7Csurreyborders.rec%40hra.nhs.uk%7Ccc94316d553f445490d408dddf0a0972%7C8e1f0acad87d4f20939e36243d574267%7C0%7C0%7C638911956383865480%7CUnknown%7CTWFpbGZsb3d8eyJFbXB0eU1hcGkiOnRydWUsIlYiOiIwLjAuMDAwMCIsIlAiOiJXaW4zMiIsIkFOIjoiTWFpbCIsIldUIjoyfQ%3D%3D%7C0%7C%7C%7C&sdata=RPGDXXfwwU79PfOC2DA2ZpXm448KBPnAV0oNjFysOgI%3D&reserved=0
  - Stefanidis, K.; Tsatsou, D.; Konstantinidis, D.; Gymnopoulos, L.; Daras, P.; Wilson-Barnes, S.; Hart, K.; Cornelissen, V.; Decort, E.; Lalama, E.; et al. PROTEIN AI Advisor: A Knowledge-Based Recommendation Framework Using Expert-Validated Meals for Healthy Diets. Nutrients 2022, 14, 4435. https://gbr01.safelinks.protection.outlook.com/?url=https%3A%2F%2Ftrack.pstmrk.it%2F3ts%2Fdoi.org%252F10.3390%252Fnu14204435%2FNBTI%2F7XW-AQ%2FAQ%2F9ea66b90-284f-490c-a6ab-f1ee56610990%2F4%2FZrDlC---__&data=05%7C02%7Csurreyborders.rec%40hra.nhs.uk%7Ccc94316d553f445490d408dddf0a0972%7C8e1f0acad87d4f20939e36243d574267%7C0%7C0%7C638911956383885075%7CUnknown%7CTWFpbGZsb3d8eyJFbXB0eU1hcGkiOnRydWUsIlYiOiIwLjAuMDAwMCIsIlAiOiJXaW4zMiIsIkFOIjoiTWFpbCIsIldUIjoyfQ%3D%3D%7C0%7C%7C%7C&sdata=WseLIJRrF4JyJLdJEwj8V84ApNjI1IQimq2b4jPvJNs%3D&reserved=0
  - S Balula Dias, Y Oikonomidis, J Alves Diniz, F Baptista, F Carnide, A Bensenousi, J María Botana, D Tsatsou, K Stefanidis, L Gymnopoulos, K Dimitropoulos, P Daras, A Argiriou, K Rouskas, S Wilson-Barnes, K Hart, N Merry, D Russell, J Konstantinova, E Lalama, A Pfeiffer, A Kokkinopoulou, M Hassapidou, I Pagkalos, E Patra, R Buys, V Cornelissen, A Batista, S Cobello, E Milli, C Vagnozzi, S Bryant, S Maas, P Bacelar, S Gravina, J Vlaskalin, B Brkic, G Telo, E Mantovani, O Gkotsopoulou, D Iakovakis, S Hadjidimitriou, V Charisis and LJ Hadjileontiadis (2022) Users' Perspective on the AI-Based Smartphone PROTEIN App for Personalized Nutrition and Healthy Living: A modified Technology Acceptance Model (mTAM) Approach. Frontiers in Nutrition. https://gbr01.safelinks.protection.outlook.com/?url=https%3A%2F%2Ftrack.pstmrk.it%2F3ts%2Fdoi.org%252F10.3389%252Ffnut.2022.898031%2FNBTI%2F7XW-AQ%2FAQ%2F9ea66b90-284f-490c-a6ab-f1ee56610990%2F5%2FkNBQ6a-3TB&data=05%7C02%7Csurreyborders.rec%40hra.nhs.uk%7Ccc94316d553f445490d408dddf0a0972%7C8e1f0acad87d4f20939e36243d574267%7C0%7C0%7C638911956383899986%7CUnknown%7CTWFpbGZsb3d8eyJFbXB0eU1hcGkiOnRydWUsIlYiOiIwLjAuMDAwMCIsIlAiOiJXaW4zMiIsIkFOIjoiTWFpbCIsIldUIjoyfQ%3D%3D%7C0%7C%7C%7C&sdata=jIENizBQ5sRE9H83eMNWFdGF5sP%2FUjiIoZs%2B8iON9wU%3D&reserved=0
  - Tsatsou D, Lalama E, Wilson-Barnes S, Hart K, Cornelissen V, Buys R, Pagkalos I, Dias S, Dimitropoulos K and Daras P (2021) NAct: The Nutrition and Activity Ontology for Healthy Living. Frontiers in Artificial Intelligence and Applications; 344: Formal Ontology in Information Systems. https://gbr01.safelinks.protection.outlook.com/?url=https%3A%2F%2Ftrack.pstmrk.it%2F3ts%2Fdoi.org%252F10.3233%252FFAIA210377%2FNBTI%2F7XW-AQ%2FAQ%2F9ea66b90-284f-490c-a6ab-f1ee56610990%2F6%2FdstSNWVao7&data=05%7C02%7Csurreyborders.rec%40hra.nhs.uk%7Ccc94316d553f445490d408dddf0a0972%7C8e1f0acad87d4f20939e36243d574267%7C0%7C0%7C638911956383914021%7CUnknown%7CTWFpbGZsb3d8eyJFbXB0eU1hcGkiOnRydWUsIlYiOiIwLjAuMDAwMCIsIlAiOiJXaW4zMiIsIkFOIjoiTWFpbCIsIldUIjoyfQ%3D%3D%7C0%7C%7C%7C&sdata=7nVk%2FUqfQ6xNVoXzwURbBIwyFSG27lxxn06CVyeOxlo%3D&reserved=0

  Abstracts accepted and presented as oral / poster presentations at external conferences including:
  - FENS (poster), Belfast 2024 - Can a mobile application deliver appropriate, acceptable and usable personalised nutrition advice to UK adults?
  - Nutrition Society Winter meeting (poster), London 2023 - The evaluation of a personalized nutrition and physical activity tool to facilitate lifestyle changes for adults with poor quality diets.
  - Nutrition Society Summer meeting (oral), Liverpool 2023 - Can a mobile application deliver appropriate, acceptable and usable personalised nutrition advice to UK adults?
  - British Dietetic Association Research Symposium (poster), Birmingham 2022 - The perceived usability of a personalized nutrition mobile app for adults with poor quality diets or excess weight.
  - Nutrition Society Irish Section conference (poster), Dublin 2022 - The utility of breath volatile organic compound (VOC) sampling as a biomarker of sub-optimal nutritional status: a UK pilot study.
  - CE Food Conference (oral), Slovenia 2022 - Personalized Nutrition for Healthy Living: The PROTEIN project and application.
  If pending, date when dissemination is expected:
  If no, explain why you didn't follow it:
  Have participants been informed of the results of the study?: Yes
  If yes, describe and/or provide URLs to materials shared and how they were shared: Participants who requested it were sent a summary of their individual results. Participants who requested information about the findings of the overarching EU project were encouraged to access materials shared via the main study website: https://gbr01.safelinks.protection.outlook.com/?url=https%3A%2F%2Ftrack.pstmrk.it%2F3t%2Fprotein-h2020.eu%252Fabout-protein%252F%2FNBTI%2F7XW-AQ%2FAQ%2F9ea66b90-284f-490c-a6ab-f1ee56610990%2F7%2FgJ0oiT5dKt&data=05%7C02%7Csurreyborders.rec%40hra.nhs.uk%7Ccc94316d553f445490d408dddf0a0972%7C8e1f0acad87d4f20939e36243d574267%7C0%7C0%7C638911956383927958%7CUnknown%7CTWFpbGZsb3d8eyJFbXB0eU1hcGkiOnRydWUsIlYiOiIwLjAuMDAwMCIsIlAiOiJXaW4zMiIsIkFOIjoiTWFpbCIsIldUIjoyfQ%3D%3D%7C0%7C%7C%7C&sdata=j3RPmrGN32nxwynm89rcTqpgWC4KMw152QqWVdb4YeI%3D&reserved=0 and via the project's social media accounts.
  If pending, date when feedback is expected:
  If no, explain why they haven't:
  Have you enabled sharing of study data with others?: Yes
  If yes, describe or provide URLs to how it has been shared: The Nutrition ontology developed during the project is available open access: https://gbr01.safelinks.protection.outlook.com/?url=https%3A%2F%2Ftrack.pstmrk.it%2F3ts%2Fgithub.com%252Fnutritionactivityontology%252Fnact%2FNBTI%2F7XW-AQ%2FAQ%2F9ea66b90-284f-490c-a6ab-f1ee56610990%2F8%2FTgoqvx8nRp&data=05%7C02%7Csurreyborders.rec%40hra.nhs.uk%7Ccc94316d553f445490d408dddf0a0972%7C8e1f0acad87d4f20939e36243d574267%7C0%7C0%7C638911956383941532%7CUnknown%7CTWFpbGZsb3d8eyJFbXB0eU1hcGkiOnRydWUsIlYiOiIwLjAuMDAwMCIsIlAiOiJXaW4zMiIsIkFOIjoiTWFpbCIsIldUIjoyfQ%3D%3D%7C0%7C%7C%7C&sdata=6qvROZIwCvItfdOb%2BaRxxM9YYKcjzZR2ZvV%2BRCaT1mY%3D&reserved=0
  If no, explain why sharing hasn't been enabled: The cross-country and multi-institutional collaborations involved in this project led to a number of legal challenges in sharing data beyond the study consortium. There were significant ethical challenges for the intervention arms of the programme largely due to the differing requirements across countries which meant that creating a unified dataset and subsequently sharing this externally was not possible. Susbsequent projects have been designed to minimise these issues and to prioritise open access.
  Have you enabled sharing of tissue samples and associated data with others?: No
  If yes, describe or provide a URL:
  If no, explain why: Tissue samples not taken by our institution. Other research partners in Germany, Greece & Belgium took tissue samples which will be handled in accordance with local policies.
  Captcha: 03AFcWeA4Ok1pIkgYo3jFm4uAXAdHbxm4CnYq7VY3E2tByFWqzJQPuZ9L38d4jPUqQw0iMQqz_u3G0PRt-kX9M-v_eUKxdueuS7zEK0A3lCm75YQ2VUyATaci4ViVC1KH5e4DcKC82zCUbunsTG-4pe6AkoXslE-_4aJ-GdqysEWbeZYZJ0pj_GJQiLWZHdnUoWXteRnkS_fHkmcpUm5zsmWOLLmBJA9tIY3sALcKlzBNxQ04uYjWqBueRD8_qy9GouG3jQw69YUoYLyGqnOiDtz8T5ftqOx64JT3bvg1vV3kvp021WxpuoUDYhuew6JoR6QiEspCVzdlxIH4rKgDOZKTZoxiNcdiJ_G3DpmKzzkhRvLTl70mDa_QXKd1Cjqko6keZdq8JfoVWtmanZQ2pJnWBp-5BiXibvSweGo2NhWoQsW8HsfTO9mkNCgvgttMB3KsZ3WTJZcbBqtwWFySbYSxDh4jJ1VNHyIjNOur7mr4HWQtjwJe2fuoHeEpPYjrhncWWgGWq8OND5TLSLsdittvS6BWWSRlIt3cYJTg_gXTPx3AWnUufAxueU_BKoenyxSpgOpfLZxY8BP6va0cV_m5LoLLowca0iho4xXazDBcSueXzrVJqITRAaOq7Ui7tWqZvWg4jjdQ6jL0Fad5NvXZYW5ITQX61AzB1It8WE5ErUhJR1InMfPWNMG5ZTdwj3KAoKZcDZxS6JBr6Fl46CDbvr4GHudU4g_g9yIkDz3_QIv3W-kweqyzC6lIJ4Oqzu8Yl6hXD2rMRkKhj6BKGgTZExJDlq8v3FV2b0GWEJWpfMX_5ZKA2HWERhPRx7jiPlI6cYksGWfVFSVBv_c20K5XUhXELYhdvHkDeMVnHej4vr8xk4v_PpWQjwZE5RIpAsZ-GsrA_QGp-G4YPtO3luPZYsMvjDSz0ACJmCm-zKJqcs3m8yoU2lcE
  

• REC name

  London - Surrey Borders Research Ethics Committee

• REC reference

  21/LO/0448

• Date of REC Opinion

  22 Jul 2021

• REC opinion

  Further Information Favourable Opinion