3D Reconstruction, VR and Machine Learning in Body Image in Bariatrics

Official title

The Use of 3D Reconstruction, Virtual Reality, and Machine Learning in Addressing Body Image in Bariatric Metabolic Surgery.

Overview

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.

Interventions

• Behavioral 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.

Primary outcome measures

• Body Weight [Time frame: 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.]
• Patient reported outcome measure - Hospital Anxiety and Depression Scale (HADS) [Time frame: 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]

Secondary outcome measures (1)

• Participant opinion on virtual reality environments. [Time frame: Duration of body image counselling sessions, average of 6 months.]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Supportive care

Study locations

United Kingdom · 1 center

• Imperial College London — London

Identifiers

NCT: NCT07668492 · 181865

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗