- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07668492
3D Reconstruction, VR and Machine Learning in Body Image in Bariatrics
The Use of 3D Reconstruction, Virtual Reality, and Machine Learning in Addressing Body Image in Bariatric Metabolic Surgery.
Studies have shown that following bariatric metabolic surgery (BMS), patients continue to experience dissatisfaction with their new body image and identity). The reason for this is poorly understood but negative body image perception after surgery is linked to poor psychological and clinical outcomes. Our pilot study looking at the acceptability and feasibility of 3D reconstruction and virtual reality (VR) in addressing body image in BMS found that participants felt better informed about how their body will change following significant weight loss and agreed this novel intervention would be beneficial in helping patients adjust to changes in their body after BMS.
The investigators propose a randomised control trial comparing group body image counselling and group body image counselling with 3D reconstruction and VR in addressing body image in BMS. The study aims to enrol 80 participants from the Tier 4 bariatric group at St Mary's Hospital and Chelsea & Westminster Hospital. After consent, participants will be divided into two groups: the control group will receive traditional group body image counselling, and the intervention group will receive the same counselling supplemented with VR and 3D reconstructed images depicting 15% and 25% total less body weight. Both groups will undergo four sessions over six months.
The investigators will collect data including body measurements and 3D images of the participant in their underwear using a secure password protected device at baseline and follow participants at 3, 6, 9, 12, 18, 24, and 36 months post-BMS. Patient reported outcomes will be assessed through patient-reported questionnaires.
This trial seeks to determine if integrating 3D reconstruction and VR technology into body image counselling can provide better support for patients adjusting to body image changes post-BMS, potentially leading to improved psychological and clinical outcomes.
Study Overview
Status
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Nazrin Assaf
- Phone Number: +44 (0) 203 315 8231
- Email: n.assaf21@imperial.ac.uk
Study Locations
-
-
-
London, United Kingdom
- Imperial College London
-
Contact:
- Nazrin Assaf
- Email: n.assaf21@imperial.ac.uk
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Tier 4 bariatric group
- On waiting list for bariatric metabolic surgery
- Able to stand unaided for at least 5 minutes
Exclusion Criteria:
- Anyone who cannot provide informed consent
- Anyone who is involved in current research or has recently been involved in any research prior to recruitment.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
No Intervention: Control Group
Body Image Counselling without Virtual Reality
|
|
|
Experimental: Intervention Group
Body Image Counselling with Virtual Reality
|
Body image counselling using personalised 3D reconstructed images of participant with 15% and 25% total body weight loss in a virtual reality environment.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Body Weight
Time Frame: Baseline and through study completion, an average of 3 years.
|
kg
|
Baseline and through study completion, an average of 3 years.
|
|
Patient reported outcome measure - Weight Bias Internalisation Scale.
Time Frame: Baseline and through study completion, an average of 3 years.
|
Minimum score 1. Maximum score 7. Score 1 - 3.9 = Low to Moderate Internalisation Score 4 = High internalisation Score 5 - 7 = Severe internalisation
|
Baseline and through study completion, an average of 3 years.
|
|
Patient reported outcome measure - Hospital Anxiety and Depression Scale (HADS)
Time Frame: Baseline and through study completion, an average of 3 years.
|
Scored by calculating separate totals for its two subscales: Anxiety (HADS-A) and Depression (HADS-D) Each subscale is scored out of 21 points 0 - 7 = Normal 8 - 10 = Borderline Abnormal / Mild 11 - 21 = Abnormal / Moderate to Severe
|
Baseline and through study completion, an average of 3 years.
|
|
Patient reported outcome measure - Body Image Questionnaire
Time Frame: Baseline, and through study completion, an average of 3 years
|
Total score ranging from 0 to 18. Score 0 - 8 = Minimal to Mild Concern Score 9 - 14 = Moderate Concern Score 15 - 28 = Severe / Probable Clinical Body Dysmorphic Disorder
|
Baseline, and through study completion, an average of 3 years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Participant opinion on virtual reality environments.
Time Frame: Duration of body image counselling sessions, average of 6 months.
|
Qualitative data based on discussions and feedback held during group sessions.
|
Duration of body image counselling sessions, average of 6 months.
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 181865
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Mental Health
-
Sanctuary Mental Health MinistriesExcellence in Giving InsightsNot yet recruitingMental Health | Mental Health Help-Seeking | Mental Health LiteracyUnited States
-
Neslihan LokCompletedAdolescent | Mental Health | Mental Health Care | Mental Health ConditionsTurkey
-
GCS-CCOMSINSERM ECEVE 1123; L'Assistance Publique - Hopitaux de Paris (AP-HP)Active, not recruitingRecovery | Organization of Health Service | Mental Health Services | Mental Health CareFrance
-
Universidad Metropolitana de Ciencias de la EducacionNot yet recruitingMental Health | Physical Inactivity | Cardiovascular Health | Mental Health Care | Sedentary BehaviorsChile
-
VA Office of Research and DevelopmentCompletedMental Health | Veterans Health | Rural HealthUnited States
-
King's College LondonCompletedMental Health Wellness 1 | Mental Health IssueUnited Kingdom
-
Cambridge Health AllianceNot yet recruitingMental Health | Adolescent Health | Minority Health | Community Health Services
-
Chapin Hall at the University of ChicagoUniversity of ConnecticutCompletedMental Health | Physical Health
-
Chinese University of Hong KongRecruitingMental Health Wellness 1 | Mental Well-being | Mental Health Issue | Precision Mental HealthHong Kong
-
Chinese University of Hong KongThe University of Hong Kong; The Hong Kong Polytechnic University; The Hong Kong... and other collaboratorsRecruitingMental Well-being | Adolescent Health | Mental Health Help-Seeking | Mental Health Literacy | School Difficulties Associated With Mental Health ProblemsHong Kong
Clinical Trials on Body Image Counselling with Virtual Reality
-
Carnegie Mellon UniversityAllegheny Singer Research Institute (also known as Allegheny Health Network...WithdrawnAdherence, Medication
-
Chang Gung Memorial HospitalCompletedCognitive Function 1, Social | Heart Rate Fast | Otolaryngologic Disorder | Competence | Learning, SpatialTaiwan
-
Cairo UniversityCompletedDuchenne Muscular Dystrophy (DMD)Egypt
-
Tzu Chi UniversityCompleted
-
Istituto Auxologico ItalianoCompletedGeneralized Anxiety DisorderItaly
-
Riphah International UniversityCompleted
-
Vimonwan HiengkaewUnknownStroke | Movement, Abnormal
-
Kırıkkale UniversityCompletedAlzheimer's DementiaTurkey
-
Laval UniversityNot yet recruitingRotator Cuff Related Shoulder PainCanada
-
Bartolome Puerta ArroyoRocío Martín ValeroNot yet recruitingCerebral Palsy | Functional Balance