The Use of Smart Devices in Capturing Digital Biomarkers in Eating Disorders
NCT Number: NCT06544226
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Eating Disorders
Interventions: DEVICE: UH100
Sponsor: Univa Health
Sex: ALL
Age: CHILD, ADULT, OLDER_ADULT
Enrollment: 130
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-09-01
Completion Date: 2025-09-01
Locations: University of Liverpool, Liverpool, L69 3GF, United Kingdom

Summary:
This study aims to explore how smart devices can be used to monitor the health of individuals with eating disorders. Eating disorders are serious mental health conditions that impact both mental and physical health. Effective monitoring is crucial for developing treatment plans and ensuring the safety of individuals both in hospitals and at home. Currently, healthcare professionals use manual methods to measure important health indicators like heart rate, blood pressure, and BMI. These methods can be time-consuming and may not always accurately reflect a patient's health due to the possibility of patients concealing the severity of their condition. Furthermore, monitoring at home is challenging due to the lack of professional equipment and training for caregivers. With advancements in digital technology, smartphones and smartwatches now have the potential to collect and analyse health data in real-time. These devices can capture data on heart rate, blood pressure, respiratory rate, and other vital signs through non-invasive methods like analysing facial and fingertip blood volume, namely the photoplethysmography technology. Additionally, video recordings from smartphone cameras can be used to assess physical and mental health by analysing facial expressions, voice patterns, and physical movements. By utilising these digital tools, combined with validated questionnaires and tasks to assess participants' psychological status and the severity of disorders, this study expects to create a more efficient and accessible way for individuals with eating disorders to monitor their health at home. The study will collect data from participants both in hospital settings and during outpatient care to ensure the reliability and effectiveness of these digital methods across participants with different levels of severity. This comprehensive approach aims to improve early detection of health issues, optimise treatment plans, and ultimately enhance the quality of life for individuals with eating disorders.

Primary Outcome Measures: Height and Weight - traditional measurement, Height (cm) and weight (kg) will be measured using standard clinical techniques. These two measurements will be used independently or to calculate the body mass index (BMI)., A maximum of two sessions per week, with two readings per session, will be conducted from week 1 to week 16. The frequency may be adjusted to align with participants' clinical visits, but the maximum duration will remain 16 weeks.|Height and Weight - PPG estimation and facial analysis, Height (cm) and weight (kg) will be estimated using independent or combined facial and fingertip photoplethysmogram (PPG) technology and facial feature analysis. These facial features will be identified and quantified using machine learning algorithms. These two measurements will be used independently or to calculate the body mass index (BMI)., A maximum of two sessions per week, with two readings per session, will be conducted from week 1 to week 16. The frequency may be adjusted to align with participants' clinical visits, but the maximum duration will remain 16 weeks.|Heart Rate - traditional measurement, Heart rate (bpm) will be measured by a sphygmomanometer in both sitting and standing postures., A maximum of two sessions per week, with two readings per session, will be conducted from week 1 to week 16. The frequency may be adjusted to align with participants' clinical visits, but the maximum duration will remain 16 weeks.|Heart Rate - PPG estimation, Heart rate (bpm) will be estimated using facial and fingertip photoplethysmogram (PPG) technology in both sitting and standing postures., A maximum of two sessions per week, with two readings per session, will be conducted from week 1 to week 16. The frequency may be adjusted to align with participants' clinical visits, but the maximum duration will remain 16 weeks.|Blood Pressure - traditional measurement, Temperature (°C) will be separately measured using a thermometer and estimated using independent or combined facial and fingertip photoplethysmogram (PPG) technology and facial feature analysis. These facial features will be identified and quantified using machine learning algorithms., A maximum of two sessions per week, with two readings per session, will be conducted from week 1 to week 16. The frequency may be adjusted to align with participants' clinical visits, but the maximum duration will remain 16 weeks.|Blood Pressure - PPG estimation, Systolic and diastolic blood pressure (mmHg) will be measured using facial and fingertip photoplethysmogram (PPG) technology in both sitting and standing postures., A maximum of two sessions per week, with two readings per session, will be conducted from week 1 to week 16. The frequency may be adjusted to align with participants' clinical visits, but the maximum duration will remain 16 weeks.|Respiratory Rate - traditional measurement, Respiratory rate (breaths per minute) will be measured by counting the number per minute manually., A maximum of two sessions per week, with two readings per session, will be conducted from week 1 to week 16. The frequency may be adjusted to align with participants' clinical visits, but the maximum duration will remain 16 weeks.|Respiratory Rate - PPG estimation and facial analysis, Respiratory rate (breaths per minute) will be estimated using independent or combined facial and fingertip photoplethysmogram (PPG) technology and facial feature analysis. These facial features will be identified and quantified using machine learning algorithms., A maximum of two sessions per week, with two readings per session, will be conducted from week 1 to week 16. The frequency may be adjusted to align with participants' clinical visits, but the maximum duration will remain 16 weeks.|Temperature - traditional measurement, Temperature (°C) will be measured using a thermometer., A maximum of two sessions per week, with two readings per session, will be conducted from week 1 to week 16. The frequency may be adjusted to align with participants' clinical visits, but the maximum duration will remain 16 weeks.|Temperature - PPG estimation and facial analysis, Temperature (°C) will be estimated using independent or combined facial and fingertip photoplethysmogram (PPG) technology and facial feature analysis. These facial features will be identified and quantified using machine learning algorithms., A maximum of two sessions per week, with two readings per session, will be conducted from week 1 to week 16. The frequency may be adjusted to align with participants' clinical visits, but the maximum duration will remain 16 weeks.|Blood Oxygen Level - traditional measurement, Blood oxygen level (SpO2) will be measured using a saturation meter, A maximum of two sessions per week, with two readings per session, will be conducted from week 1 to week 16. The frequency may be adjusted to align with participants' clinical visits, but the maximum duration will remain 16 weeks.|Blood Oxygen Level - PPG estimation and facial analysis, Blood oxygen level (SpO2) will be estimated using independent or combined facial and fingertip photoplethysmogram (PPG) technology and facial feature analysis. These facial features will be identified and quantified using machine learning algorithms., A maximum of two sessions per week, with two readings per session, will be conducted from week 1 to week 16. The frequency may be adjusted to align with participants' clinical visits, but the maximum duration will remain 16 weeks.|Blood Glucose Level - traditional measurement, Blood glucose level (mmol/L or mg/dL) will be measured through blood tests., A maximum of two sessions per week will be conducted from week 1 to week 16. The frequency may be adjusted to align with participants' clinical visits, but the maximum duration will remain 16 weeks.|Blood Glucose Level - PPG estimation and facial analysis, Blood glucose level (mmol/L or mg/dL) will be estimated using independent or combined facial and fingertip photoplethysmogram (PPG) technology and facial feature analysis. These facial features will be identified and quantified using machine learning algorithms., A maximum of two sessions per week, with two readings per session, will be conducted from week 1 to week 16. The frequency may be adjusted to align with participants' clinical visits, but the maximum duration will remain 16 weeks.|Hydration Level - traditional measurement, Hydration level will be assessed through the number and type of dehydration symptoms., A maximum of two sessions per week will be conducted from week 1 to week 16. The frequency may be adjusted to align with participants' clinical visits, but the maximum duration will remain 16 weeks.|Hydration Level - PPG estimation and facial analysis, Hydration level will be estimated using independent or combined facial and fingertip photoplethysmogram (PPG) technology and facial feature analysis. These facial features will be identified and quantified using machine learning algorithms., A maximum of two sessions per week, with two readings per session, will be conducted from week 1 to week 16. The frequency may be adjusted to align with participants' clinical visits, but the maximum duration will remain 16 weeks.|Rating of Skin Conditions - traditional measurement, Skin conditions will be assessed through the number and type of skin conditions., A maximum of one session per week will be conducted from week 1 to week 16. The frequency may be adjusted to align with participants' clinical visits, but the maximum duration will remain 16 weeks.|Rating of Skin Conditions - PPG estimation and facial analysis, Skin conditions will be estimated using facial feature analysis. These facial features will be identified and quantified using machine learning algorithms., A maximum of two sessions per week, with two readings per session, will be conducted from week 1 to week 16. The frequency may be adjusted to align with participants' clinical visits, but the maximum duration will remain 16 weeks.|Sit-Up-Squat-Stand Test - traditional measurement, Participants' core strength, flexibility, and balance will be assessed using the Sit-Up-Squat-Stand Test with a 4-point scale to separately rate Sit-Up and the Squat-Stand performance., A maximum of two sessions per week will be conducted from week 1 to week 16. The frequency may be adjusted to align with participants' clinical visits, but the maximum duration will remain 16 weeks.|Sit-Up-Squat-Stand Test - PPG estimation and facial and body movement analysis, Participants' core strength, flexibility, and balance will be estimated by using independent or combined facial photoplethysmogram (PPG) technology and the analysis of changes in body movements and facial features. These movements and features will be identified and quantified using machine learning algorithms., A maximum of two sessions per week will be conducted from week 1 to week 16. The frequency may be adjusted to align with participants' clinical visits, but the maximum duration will remain 16 weeks.|Single Anxiety and Depression Questions, Participants' anxiety and depression (mood) status on the day of the assessment session will be evaluated using two single-item questions, each with a 100-point visual analogue scale., A maximum of two sessions per week, with two tests conducted after each set of readings, will be carried out from week 1 to week 16. The frequency may be adjusted to align with participants' clinical visits, but the maximum duration will remain 16 weeks.|The Size of The Parotid Glands - traditional measurement, The size of the parotid glands will be assessed by clinicians or professionals to determine if it is normal., A maximum of two sessions per week will be conducted from week 1 to week 16. The frequency may be adjusted to align with participants' clinical visits, but the maximum duration will remain 16 weeks.|The Size of The Parotid Glands - PPG estimation and facial and body movement analysis, The size of the parotid glands will be estimated using facial feature analysis. These facial features will be identified and quantified using machine learning algorithms., A maximum of two sessions per week, with two readings per session, will be conducted from week 1 to week 16. The frequency may be adjusted to align with participants' clinical visits, but the maximum duration will remain 16 weeks.|Blood Tests (full blood count), The blood test is used to assess electrolyte balance, including the result of full blood count., A maximum of one session per week will be conducted from week 1 to week 16. The frequency may be adjusted to align with participants' clinical visits, but the maximum duration will remain 16 weeks.|Blood Tests (Haemoglobin), The blood test is used to assess electrolyte balance, including the result of Haemoglobin (g/dL or g/L)., A maximum of one session per week will be conducted from week 1 to week 16. The frequency may be adjusted to align with participants' clinical visits, but the maximum duration will remain 16 weeks.|Blood Tests (Platelets), The blood test is used to assess electrolyte balance, including the result of Platelets (10\^3/μL or 10\^9/L)., A maximum of one session per week will be conducted from week 1 to week 16. The frequency may be adjusted to align with participants' clinical visits, but the maximum duration will remain 16 weeks.|Blood Tests (white cell counts), The blood test is used to assess electrolyte balance, including the result of white cell counts (10\^3/μL or 10\^9/L)., A maximum of one session per week will be conducted from week 1 to week 16. The frequency may be adjusted to align with participants' clinical visits, but the maximum duration will remain 16 weeks.|Blood Tests (potassium (K+)), The blood test is used to assess electrolyte balance, including the result of potassium (K+) (mEq/L or mmol/L)., A maximum of one session per week will be conducted from week 1 to week 16. The frequency may be adjusted to align with participants' clinical visits, but the maximum duration will remain 16 weeks.|Blood Tests (sodium (Na+)), The blood test is used to assess electrolyte balance, including the result of sodium (Na+) (mEq/L or mmol/L)., A maximum of one session per week will be conducted from week 1 to week 16. The frequency may be adjusted to align with participants' clinical visits, but the maximum duration will remain 16 weeks.|Blood Tests (magnesium (Mg++)), The blood test is used to assess electrolyte balance, including the result of magnesium (Mg++) (mEq/L, mg/dL, or mmol/L)., A maximum of one session per week will be conducted from week 1 to week 16. The frequency may be adjusted to align with participants' clinical visits, but the maximum duration will remain 16 weeks.|Blood Tests (phosphorous (PO4)), The blood test is used to assess electrolyte balance, including the result of phosphorous (PO4) (mEq/L, mg/dL, or mmol/L)., A maximum of one session per week will be conducted from week 1 to week 16. The frequency may be adjusted to align with participants' clinical visits, but the maximum duration will remain 16 weeks.|Blood Tests (urea), The blood test is used to assess electrolyte balance, including the result of urea (mEq/L, mg/dL, or mmol/L)., A maximum of one session per week will be conducted from week 1 to week 16. The frequency may be adjusted to align with participants' clinical visits, but the maximum duration will remain 16 weeks.|Blood Tests (creatine kinase), The blood test is used to assess electrolyte balance, including the result of creatine kinase (U/L or µkat/L)., A maximum of one session per week will be conducted from week 1 to week 16. The frequency may be adjusted to align with participants' clinical visits, but the maximum duration will remain 16 weeks.|Blood Tests (albumin), The blood test is used to assess electrolyte balance, including the result of albumin (g/dL)., A maximum of one session per week will be conducted from week 1 to week 16. The frequency may be adjusted to align with participants' clinical visits, but the maximum duration will remain 16 weeks.|Blood Tests (alkaline phosphatase (ALP)), The blood test is used to assess electrolyte balance, including the result of alkaline phosphatase (ALP) (U/L or µkat/L)., A maximum of one session per week will be conducted from week 1 to week 16. The frequency may be adjusted to align with participants' clinical visits, but the maximum duration will remain 16 weeks.|Blood Tests (aspartate transaminase (AST)), The blood test is used to assess electrolyte balance, including the result of aspartate transaminase (AST) (U/L or µkat/L)., A maximum of one session per week will be conducted from week 1 to week 16. The frequency may be adjusted to align with participants' clinical visits, but the maximum duration will remain 16 weeks.|Blood Tests (alanine transaminase (ALT)), The blood test is used to assess electrolyte balance, including the result of alanine transaminase (ALT) (U/L or µkat/L)., A maximum of one session per week will be conducted from week 1 to week 16. The frequency may be adjusted to align with participants' clinical visits, but the maximum duration will remain 16 weeks.|Blood Tests (gamma-glutamyl transferase (GGT)), The blood test is used to assess electrolyte balance, including the result of gamma-glutamyl transferase (GGT) (U/L or µkat/L)., A maximum of one session per week will be conducted from week 1 to week 16. The frequency may be adjusted to align with participants' clinical visits, but the maximum duration will remain 16 weeks.|Blood Tests (bilirubin), The blood test is used to assess electrolyte balance, including the result of bilirubin (mg/dL or μmol/L)., A maximum of one session per week will be conducted from week 1 to week 16. The frequency may be adjusted to align with participants' clinical visits, but the maximum duration will remain 16 weeks.|Blood Tests (glucose), The blood test is used to assess electrolyte balance, including the result of glucose (mg/dL or mmol/L)., A maximum of one session per week will be conducted from week 1 to week 16. The frequency may be adjusted to align with participants' clinical visits, but the maximum duration will remain 16 weeks.|Video Diary Entry, When participants are asked to record their thoughts on diary questions, changes in their aforementioned facial PPG-related biomarkers, facial features, and voice patterns, along with their qualitative responses, will be recorded and analysed. The facial features and voice patterns will be identified and quantified using machine learning algorithms., A maximum of one session per week will be conducted from week 1 to week 16. The frequency may be adjusted to align with participants' clinical visits, but the maximum duration will remain 16 weeks.|Image Response Task, When participants are asked to record their thoughts on high-calorie food, low-calorie food, neutral, and positive images, changes in their aforementioned facial PPG-related biomarkers, facial features, and voice patterns, along with their qualitative responses, will be recorded and analysed. The facial features and voice patterns will be identified and quantified using machine learning algorithms., A maximum of one session per week will be conducted from week 1 to week 16. The frequency may be adjusted to align with participants' clinical visits, but the maximum duration will remain 16 weeks.|Generalised Anxiety Disorder (GAD-7) and Patient Health (PHQ-9) Questionnaires, Participants' overall anxiety and depression levels will be assessed using the 7-item GAD-7 and the 9-item PHQ-9, respectively. Both scales are rated on a 4-point scale from 0 to 3. Adolescents will use the adolescent version of the PHQ-9 (PHQ-A), which employs the same scaling and scoring system, allowing for direct comparison with adults., A maximum of one session per week will be conducted from week 1 to week 16. The frequency may be adjusted to align with participants' clinical visits, but the maximum duration will remain 16 weeks.|The Eating Disorder Examination Questionnaire (EDE-Q), Participants' eating disorder traits, including eating restraint, eating concern, weight concern, and shape concern, along with qualitative responses regarding the frequency of eating disorder behaviours, will be assessed using the 28-item EDE-Q. This questionnaire is rated on a 7-point scale from 0 to 6. Adolescents will use the adolescent version of the EDE-Q (EDE-A). While this adolescent version contains 36 items, 28 of them capture the same domains as the adult version., Three times throughout the study: in Weeks 1, 8, and 16, or at discharge, or when care plans change and no further visits to clinical sites are scheduled before Week 16.|The Food-specific Stop Signal Task, Three variables are generated by this task to assess participants' inhibitory control related to food. These variables include stop signal reaction time (SSRT), go reaction time (GORT), and the proportion of successful stops or error rates. SSRT, measured in milliseconds, assesses the latency of inhibition and reflects an individual's ability to suppress an automatic response. GORT, also measured in milliseconds, evaluates the speed of responses to go signals, providing insight into baseline response times and overall task performance. The proportion of successful stops or error rates indicates the percentage of trials where participants successfully inhibit their responses., Three times throughout the study: in Weeks 1, 8, and 16, or at discharge, or when care plans change and no further visits to clinical sites are scheduled before Week 16.|Patient Acceptance Questionnaire, Participants' comfort with conducting the procedures of this study, such as recording their faces, will be assessed using an 8-item self-developed questionnaire with a 6-point rating scale, such as from 'Very comfortable' to 'Very uncomfortable'., Three times throughout the study: in Weeks 1, 8, and 16, or at discharge, or when care plans change and no further visits to clinical sites are scheduled before Week 16.