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.
Eating disorders are complex mental health conditions characterised by abnormal eating habits and distressing thoughts about body weight and shape, significantly impacting both mental and physical health. According to the International Classification of Diseases, 11th Revision, feeding and eating disorders include several subtypes such as anorexia nervosa (AN), bulimia nervosa (BN), and binge eating disorder (BED). These subtypes often involve patterns of restrictive or excessive food intake, leading to severe health issues and impairments in daily functioning. Given the rising incidence and profound impacts of eating disorders in recent years, including high mortality rates and significant economic burdens, there is an urgent need for innovative management strategies and more efficient triage and monitoring systems for early intervention and home-based care. For the care of individuals with eating disorders, comprehensive and continuous assessment of physical and psychiatric conditions is essential. As recommended by the UK's National Institute for Health and Care Excellence (NICE) and the Royal College of Psychiatrists, key clinical markers monitored, include weight loss, BMI, heart rate, blood pressure, temperature, hydration status, and muscular function. Monitoring these markers is crucial for early detection of medical complications, such as electrolyte imbalances, cardiac arrhythmias, and orthostatic hypotension, which pose serious health risks. Additionally, these markers help evaluate the disorder's severity, guide treatment adjustments, and ensure patient safety during recovery. However, traditional methods used to assess these biomarkers are burdensome and time-consuming. With the advancement of technology, novel smart devices can efficiently detect traditional biomarkers such as heart rate and blood pressure, while also exploring potential novel measures of the disease. Therefore, this study aims to validate and explore the potential of these technologies to provide monitoring comparable to traditional methods and to integrate collected data to generate sophisticated insights into the health status of individuals with eating disorders. According to previous research, the analysis of facial information, including static features and dynamic movements, combined with advanced algorithms and machine learning, can estimate body weight, BMI, parotid gland size, and skin condition. When voice pattern analysis is integrated with facial dynamics during the video diary entry phase and the image response task, where participants share their thoughts on specific images, it is expected to further assess physical and psychological states, particularly when discussing sensitive topics or images, such as high-calorie foods. These estimations can be used to interpret the health status of individuals with eating disorders. Additionally, photoplethysmography (PPG) using smart devices can detect subtle changes in the colour spectrum induced by blood volume dynamics in facial and fingertip areas, allowing for the estimation of heart rate (HR), blood pressure (BP), respiratory rate (RR), blood oxygen level, blood glucose, and body temperature. This technology, which has been validated in healthy subjects, shows significant potential for application in patients with eating disorders, who are prone to cardiovascular and respiratory issues due to physiological stress and nutritional imbalances. This approach provides essential insights into their physical health status, particularly given the significant impairments in muscle strength often observed in individuals with eating disorders. In addition to physical health, this study will also examine psychological traits that may improve the accuracy of identifying eating disorder status. This will include questionnaire-based assessments and a computerised task to measure psychological processes. Specifically, the 7-item Generalised Anxiety Disorder Questionnaire (GAD-7) and the 9-item Patient Health Questionnaire (PHQ-9) will assess anxiety and depression severity, respectively, while the Eating Disorder Examination Questionnaire (EDE-Q) will evaluate eating disorder traits, including eating restraint, eating concern, shape concern, and weight concern. Adolescent versions of these questionnaires will be used for younger participants. Moreover, since impulsivity and cognitive control are often altered in individuals with eating disorders, this study will assess these cognitive functions using an adapted Stop Signal Task (SST) that incorporates sensitive cues, such as high-calorie food cues (food-specific SST, FSST). This task will aid in monitoring cognitive control related to the progression of eating disorders and potentially improve the accuracy of health status assessments in these individuals. This study aims to validate the aforementioned biomarkers and models captured by the smart device and to explore changes in these biomarkers and psychological status across different stages and severities of eating disorders. Data will be collected over 16 weeks from both hospitalised patients and outpatients. Most data, including vital and physical biomarkers, facial information, and self-reported anxiety and depression measures, will be collected weekly, either once or twice a week, with adjustments for those with less frequent visits. Whereas the EDE-Q, the FSST task, and the patient acceptance questionnaire, which assesses patients' acceptance of the data collection procedures, will be conducted three times during the study, in weeks 1, 8, and 16. By conducting this study, the investigators expect to enhance the usability and acceptance of non-invasive monitoring tools, providing valuable insights into the health status of individuals with eating disorders.
Study Type
OBSERVATIONAL
Enrollment
130
This is a non-interventional pilot study. Given the within-subject and longitudinal design used in this study, traditional intervention settings are not applicable. All participants will receive weekly and tri-point assessments, * Weekly (twice per week) Assessments: Physical vitals such as BMI, Blood Pressure, Heart Rate * Weekly (once per week) Assessments: Sit-Up-Squat-Stand Test, Video diary entries, GAD-7, and PHQ-9. * Tri-point (week 1, 8, 6) assessments: EDE-Q, Patient Acceptance Questionnaire and the Food-specific Stop Signal Task.
University of Liverpool
Liverpool, United Kingdom
RECRUITINGHeight 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).
Time frame: 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).
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Three times throughout the study: in Weeks 1, 8, and 16-or-at early 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.
Time frame: Three times throughout the study: in Weeks 1, 8, and 16-or-at early 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'.
Time frame: Three times throughout the study: in Weeks 1, 8, and 16-or-at early discharge, or when care plans change and no further visits to clinical sites are scheduled before Week 16.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.