The Use of Smart Devices in Capturing Digital Biomarkers in Eating Disorders

NCT06544226 | Recruiting DMC

• 1 other identifier: ST001
• Study Type: observational
• Target: 130
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Eating Disorders

Keywords

Eating Disorders; Photoplethysmography; Biomarkers; Vital Signs; Physical Signs

Outcome Measures

Primary Outcomes (46)

• 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 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.

  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'.

  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.

Study Arms (1)

Group of eating disorder patients aged above 10

This is a cohort study in which all participants are diagnosed with eating disorders and undertake the same set of assessments and tasks, although the frequency of these assessments and tasks is subject to their current care plan.

Device: UH100

Interventions

UH100 DEVICE

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.

Group of eating disorder patients aged above 10

Eligibility Criteria

• Age: 10 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Participants will be identified and recruited from child and adult eating disorder hospital wards and specialist secondary care child and adult eating disorder outpatient treatment teams.

You may qualify if:

• All participants must be aged 10 years or older.
• Diagnosed with an eating disorder by a clinician as per the World Health Organization\'s ICD-10 (F50.0 through F50.9) or ICD-11 (6B80 - 6B85; 6B8Y, 6B8Z) classification
• Must have a minimum once weekly in-person clinic physical assessment as part of their current treatment plan at the start of the study participation
• Fluent in English
• Capable of reading and understanding the information sheets and consent forms to provide written informed consent.
• For participants aged between 10 and 16 years, parental consent is required first before offering the opportunity to the child. A parent or legal guardian must also be able to read and understand the information sheets and consent forms to provide written informed consent on behalf of the child under 16 years of age.

You may not qualify if:

• Active substance use such as drug or alcohol misuse
• For alcohol consumption of more than 21 units of alcohol per week (1 unit is equivalent to half a pint of beer (285ml), 25ml of spirits, or one glass of wine)
• Diagnostic coding for current mental and behavioural disorders due to substances (ICD10: F10 through F19; ICD11: QE10 through QE1Z and 6C40 through 6C4H)
• A diagnosis of a neurological disorder, including but not limited to cerebrovascular diseases, either currently or in the past or where the eating disorder for which the participant is being treated is considered aetiologically-secondary to a neurological disorder (e.g. pica secondary to a brain injury).
• A diagnosis of schizophrenia or related psychotic disorder.
• Pregnancy.
• A diagnosis of developmental learning disorder (ICD10 F80.0 through F81.9: ICD11: 6A03) or intellectual disorders (ICD10: F70.0 through F79.9; ICD11 6A00).

Sponsors & Collaborators

• Univa Health: lead

Study Sites (1)

University of Liverpool

Liverpool, L69 3GF, United Kingdom

RECRUITING

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MeSH Terms

Conditions

Feeding and Eating Disorders

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders

Study Officials

• Daniel Joyce, MRCPsych

  University of Liverpool

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Richard Andrews, BSc

CONTACT

+441488892853; research@univa.health

Peter Sheng Yao Hsu, PhD

CONTACT

peter@univa.health

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 16, 2024
• First Posted: August 9, 2024
• Study Start: November 1, 2024
• Primary Completion: April 1, 2025
• Study Completion: September 1, 2025
• Last Updated: December 6, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)