3 Data collection
Data for the ON LiMiT study will be collected from multiple sources, including participants, healthcare professionals, lab technicians, and electronic devices. This section describes what, where, and how these sources of data will be collected.
3.1 Sources and methods
Participants will provide data through a variety of sources, the primary being the Liva Healthcare app which will record lifestyle information in REDCap. Connected devices such as smart watch and smart scales will transmit data directly to the Liva app.
Additional data will be gathered with a SENS accelerometer and a blinded Libre CGM which will be uploaded either into REDCap or directly to GenomeDK. Some scanner results will be uploaded via REDCap (DXA and Fibro) others will be uploaded directly to GenomeDK (VO2Max and Finapres).
We will also be collecting data from MyFood24, which is a website where participants will be asked to keep a very detailed food diary for three days at a couple of points during the study. Some participants will also be asked to do a Food Preference test which we expect to upload into REDCap.
Healthcare professionals and lab technicians will enter clinical and biological sample data into REDCap forms, and laboratory data may be uploaded from internal systems where applicable.
Further details can be seen in the diagram below.
3.2 Frequency of collection
The aim is to collect participant app and web based data (Liva, RECap, MyFood24) on a monthly basis.
Sensor and scanner data (SENS, Libre, Fibro scans, and DXA scans) will be uploaded at clinic visits, as we expect to sign off on a visit as soon as it is finished.
3.3 Data formats
- REDCap: Structured tabular data in CSV imported to GenomeDK via API.
- Liva app: CSV exports via FTP to GenomeDK. The watch and scales data are directly imported into Liva app.
- MyFood24: CSV import from secure website into GenomeDK.
- Scanners: CSV files uploaded into REDCap or directly to GenomeDK.
3.4 Estimated raw data volumes for the feasibility study
REDCap clinical data: Unknown.
- REDCap clinical data: Unknown size at present. . Liva app data: Unknown size at present. - MyFood24 dietary logs: Unknown size at present. - Sensor data (SENS, Libre): Unknown size at present. - Scanner data: - VO2Max: 20KB times 1 reading per visit, 4 visits = 20x4x24 = 2MB. - Finapres: 60KB times 8 readings per visit, 6 visits = 60x8x6x24 = 69MB. ## Data aggregation and storage
The REDCap database serves as the central hub for most clinical and scanner data, including manual uploads from devices such as SENS and Libre, and potentially iMotions. The Liva app aggregates participant lifestyle data and connected device readings. There will also be test results (like VO2Max and Finapres) that will be sent to GenomeDK directly, and this is the same as with data from MyFood24.
GenomeDK’s servers will be the final repository for processed and collated data, ensuring a central location for secure storage of data and computational capacity for analysis.
See the Storage, backup, recovery, and access for further details.
3.5 Quality assurance
We will set up and run automated checks in REDCap to ensure completeness and consistency of clinical data. The person responsible will be the Data Architect.
Uploaded sensor device data will be checked against expected ranges and timestamps. The people responsible will be the on-site staff who are using REDCap during data collection.
We will run checks to identify any missingness in the data or any anomalies and report on the results (if any). We will do any follow-up procedures to correct for these issues, which we will run during transfer to GenomeDK. The person responsible for this will be the Data Architect.
3.6 Visualisation of data flow in ON LiMiT
Underneath the diagram is a more detailed description of the components and their interactions.
flowchart LR Lab(["<b>Lab staff</b><br>collecting and analysing biological samples from participants."]) HP(["<b>Healthcare professional</b><br>working with the participants in the study."]) Pt(["<b>Participant</b><br>participating in the study."]) Red(["<b>REDCap db</b><br>database, main purpose is to collate data before it is uploaded onto GenomeDK."]) Genome(["<b>GenomeDK</b><br>HPC facility where the processed data will be stored. "]) Forms["<b>Forms in REDCap</b><br>multiple forms and questionnaires for both healthcare staff and participants"] Liva["<b>Liva</b><br>main study app which allows users to enter information about meals, activity, etc"] MyF["<b>MyFood24</b><br>website designed to register a detailed food diary"] iMo["<b>iMotions Food Preference</b><br>tracks eye movement of participants when looking at pictures of food."] Sen["<b>SENS</b><br>activity monitor, placed on the study participant and then collected and read in the clinic."] Lib["<b>Libre</b><br>Blinded CGM sensor from Abbott which participants will be wearing. Will be read in the clinic."] Watch["<b>Watch</b><br>smart watch which will connect to the Liva app."] Scales["<b>Scales</b><br>smart scales which will connect to the Liva app."] BP["<b>Blood Pressure monitor</b><br>the user will measure their blood pressure and enter it into the app."] %%MBox["<b>Meal Boxes</b><br>contains recipes and ingredients for two meals a day."] Lab -->|Uploads data from systems ?| Forms HP --> |Completes data forms| Forms Forms --- Red Red -->|API| Genome Pt -->|Enters data| Liva Pt -->|Enters data| MyF Pt -->|Enters data| iMo Pt -->|Wears for a week| Sen Pt -->|Wears for two weeks| Lib Pt -->|Wears continuously| Watch Pt --> |Uses| Scales Pt --> |Uses|BP %%Pt --> |Chooses| MBox iMo --> |??| Red Sen -->|Manual upload| Red Lib -->|Manual upload| Red Watch -->|transmits| Liva Scales -->|transmits| Liva BP -->|Participant enters results| Liva Liva --> |ftp| Genome MyF --> |website download| Genome %%MBox --> |?? may also be to RedCap| Genome
3.6.1 REDCap
REDCap is a secure web application for building and managing online surveys and databases. It is used to collect data from participants and healthcare professionals in the ON LiMiT project. REDCap will have two main functions, the first is to collect data from clinicians and participants via forms and questionnaires, and the second is to collate data from other systems, likely through APIs or csv uploads.
3.6.2 iMotions Food Preference
iMotion Food Preference is a system that tracks the eye movements of participants when they are looking at pictures of food. The data collected by this system can be pulled out as csv files and uploaded to the REDCap database or directly to the GenomeDK server.
3.6.3 SENS
SENS is an activity monitor that will be placed on the study participants for a week. The data collected by a SENS device will be extracted at clinic visits and the data will be uploaded to the REDCap database. The SENS device will track the participants’ physical activity levels in selected weeks of the study.
3.6.4 Libre
Libre is a blinded continuous glucose monitoring (CGM) sensor from Abbott that will be worn by the participants for a week. The data collected by the Libre device will be extracted at clinic visits and uploaded to the REDCap database. The Libre device will track the participants’ glucose levels in selected weeks of the study.
3.6.5 Liva Healthcare app
Liva is a mobile app that will be used by the participants to track their physical activity (via Garmin activity watch), adherence to the assigned diet intervention (via short diet screener), body weight (via Gamin scale), answer other small questionnaires, follow the study schedule, and interact with study personnel via a chat function. The app will likely connect to the REDCap database via an API, allowing the data to be automatically uploaded to the database.
3.6.6 Garmin watch and scales
The Garmin watch and scales will be used by the participants to track their physical activity and weight. The data collected by these devices will be transmitted to the Liva app where it will be collated and then transmitted to GenomeDK. The watch will track the participants’ physical activity levels, while the scales will track their weight, both will submit their measurements to the Liva app.