Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT04829851 |
| Other study ID # |
PROTEIN |
| Secondary ID |
|
| Status |
Completed |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
October 1, 2021 |
| Est. completion date |
December 30, 2022 |
Study information
| Verified date |
May 2023 |
| Source |
University of Surrey |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial 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).
Description:
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.
1. 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)
ii) Health Care Professionals (HCPs):
HCPs involved in supporting the dietary or activity goals of target clients will also be
recruited to the HCP arm of the study. The project will be promoted through local (and,
if remote, National) professional networks and professional body membership lists,
newsletters and via relevant social media channels. HCPs will have the option to
participate in a desk-based expert review of the application (without registering
specific clients) with respect to its usability or to register one or more of their own
clients on the app via the user dashboard to participate in the efficacy review. In the
latter case suitable clients identified by the HCP will be required to also register
with the trial. The HCP will be provided with flyers and invitation letters to allow
them to make first contact with the client who will be asked to contact the research
team to confirm their willingness to participate, ensuring no personal data is shared
prior to consent being received.
2. Baseline measurements:
i) Public, Face to face: Users will attend the lab and will then have their body
composition measured (to include their height, weight, waist and hip circumference) by
the researchers.
ii) Public, Remote: An alternative remote protocol will utilise Zoom/ Microsoft teams
video call. These will be arranged by the researchers with the participants to take them
through self-completion of the baseline measures and procedures.
iii) HCPs: HCPs 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.
3. PROTEIN app usage for public:
Following this, the users will be requested to log the following details to set-up the
PROTEIN system: contact details (name/ email/phone number), age, gender, height, weight,
ethnicity, morbidity status (such as cardiovascular disease/ diabetes mellitus etc.),
education/ socioeconomic status, smoking status, diet or drink habits (such as
vegetarian/ vegan/ dairy-free etc.), and medication.
Daily food and fluid intake will be collected via the PROTEIN app and will be
self-reported by the user/ participant.
Users will be asked to log all dietary and fluid intake for 7 days per week (to include
the weekend) into the home PROTEIN application suite.
Users will either use their respective smartwatches/activity trackers or manually input
the relevant data into the home PROTEIN application suite. In the former case, physical
activity and sleep data will be collected in daily summaries as provided by Google Fit
(or a suitable alternative, such as Garmin, FitBit, Polar, Apple watch etc.).
Smart watches may be provided free of charge for a subset of users (subject to trial
resources) and there may also be an opportunity for participants to use their own
existing smartwatches. In the latter case, users will be requested to manually log daily
activity data, for 7 days per week.
Users will be monitored by the PROTEIN artificial intelligence (AI) system for
deviations from their suggested plan and for any meal or activity swaps requested to
check for adherence/ compliance to the recommendations suggested by the PROTEIN AI
system.
A subset of users who are also registered with OCADO will receive food shopping
recommendations (in the form of a shopping list) tailored to their nutritional
requirements and targets; budget will also be taken into account. Participants will be
asked to indicate all food products that they swapped/ bought and for whom they bought
them within the PROTEIN application suite. This will be conducted in partnership with
OCADO.
4. After at least 4 weeks of usage, data will be collected regarding the user and HCP
experience via an online questionnaire through the PROTEIN app or sent usability
questionnaires via email by the researchers.
5. Follow-up measures:
i) Public, Face to face: Users will attend the lab after at least 4 weeks of usage and
will then have their body composition remeasured (to include their height, weight, waist
and hip circumference) by the researchers. They will also be asked to provide feedback
on the usability of the application by completing two questionnaires on the 1) usability
of the application and 2) suitability for general public use.
ii) Public, Remote: An alternative remote protocol will utilise Zoom/ Microsoft teams
video call. These will be arranged by the researchers with the participants to take them
through self-completion of the follow-up measures following at least 4 weeks of usage.
Participants will be asked to provide feedback via two online questionnaires on the 1)
usability of the application and 2) suitability for general public use.
iii) HCPs: HCPs 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 their
feedback following usage of the expert dashboard for at least 4 weeks. They will be
asked to provide feedback via two questionnaires on the 1) usability of the application
and 2) suitability for usage by health care professionals.
A subset of participants (from all groups), representing both those who have engaged or
not with the app, will also be contacted by the researchers after their trial period has
ended and invited to take part in additional qualitative measures, such as focus group
interviews to provide more feedback on their experience of the PROTEIN app.
