NCT07668492

Brief Summary

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 Health

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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
44mo left

Started Jun 2026

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress5%
Jun 2026Mar 2030

Study Start

First participant enrolled

June 1, 2026

Completed
14 days until next milestone

First Submitted

Initial submission to the registry

June 15, 2026

Completed
10 days until next milestone

First Posted

Study publicly available on registry

June 25, 2026

Completed
3.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2029

Expected
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2030

Last Updated

June 25, 2026

Status Verified

June 1, 2026

Enrollment Period

3.5 years

First QC Date

June 15, 2026

Last Update Submit

June 19, 2026

Conditions

Keywords

3D ReconstructionVirtual RealityBody ImageMachine LearningBariatric Metabolic Surgery

Outcome Measures

Primary Outcomes (4)

  • Body Weight

    kg

    Baseline and through study completion, an average of 3 years.

  • Patient reported outcome measure - Weight Bias Internalisation Scale.

    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)

    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

    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 Outcomes (1)

  • Participant opinion on virtual reality environments.

    Duration of body image counselling sessions, average of 6 months.

Study Arms (2)

Control Group

NO INTERVENTION

Body Image Counselling without Virtual Reality

Intervention Group

EXPERIMENTAL

Body Image Counselling with Virtual Reality

Behavioral: Body Image Counselling with Virtual Reality

Interventions

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

Intervention Group

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Tier 4 bariatric group
  • On waiting list for bariatric metabolic surgery
  • Able to stand unaided for at least 5 minutes

You may not qualify if:

  • Anyone who cannot provide informed consent
  • Anyone who is involved in current research or has recently been involved in any research prior to recruitment.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Imperial College London

London, United Kingdom

Location

MeSH Terms

Conditions

ObesityPsychological Well-Being

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsPersonal SatisfactionBehavior

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 15, 2026

First Posted

June 25, 2026

Study Start

June 1, 2026

Primary Completion (Estimated)

December 1, 2029

Study Completion (Estimated)

March 1, 2030

Last Updated

June 25, 2026

Record last verified: 2026-06

Data Sharing

IPD Sharing
Will not share

Locations