Imperial College London
London, United Kingdom
NCT Number: NCT07668492
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.
Trial opening soon.
Get Notified18 year–75 year
All sexes
Interventional
Not applicable
London, United Kingdom
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Body image counselling using personalised 3D reconstructed images of participant with 15% and 25% total body weight loss in a virtual reality environment.
Time frame: Baseline and through study completion, an average of 3 years.
kg
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
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
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
Time frame: Duration of body image counselling sessions, average of 6 months.
Qualitative data based on discussions and feedback held during group sessions.
Contact information is provided by the study sponsor or research team.
Imperial College London
Other
The Use of 3D Reconstruction, Virtual Reality, and Machine Learning in Addressing Body Image in Bariatric Metabolic Surgery.
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