RECRUITINGOBSERVATIONAL

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

A Novel Pilot Study Examining the Potential of Smartphones to Capture New Types of Data That Can Accurately Assess the Physiological and Psychological Health Status of an Individual With an Eating Disorder

About This Trial

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.

Who May Be Eligible (Plain English)

Who May Qualify: - 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 willing to sign a consent form. - 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 willing to sign a consent form on behalf of the child under 16 years of age. Who Should NOT Join This Trial: - 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). Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language

Inclusion Criteria: * 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. Exclusion Criteria: * 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).

Treatments Being Tested

DEVICE

UH100

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.

Locations (1)

University of Liverpool

Liverpool, United Kingdom