Clinical trial

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

Opening soon · Not applicable · 1 countries · Registry ID NCT07668492

Opening soonNot applicableInterventional

What this study is about

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.

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age18 Years to 75 Years

SexAll

Healthy volunteersNot accepted

ConditionObesity (Disorder), Body Image, Mental Health, Bariatric Surgery

Full registry 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.

Treatments and study arms

Body Image Counselling with Virtual Reality

Behavioral

Body image counselling using personalised 3D reconstructed images of participant with 15% and 25% total body weight loss in a virtual reality environment.

Primary outcomes

Body WeightBaseline and through study completion, an average of 3 years.

Patient reported outcome measure - Weight Bias Internalisation Scale.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

Patient reported outcome measure - Hospital Anxiety and Depression Scale (HADS)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

Patient reported outcome measure - Body Image QuestionnaireBaseline, 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

Study locations

1 locations were listed when this page was built. The first 40 are shown.

Imperial College London🇬🇧 London, United Kingdom

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Nazrin AssafContact