Obesity (Disorder)NCT07668492
3D Reconstruction, VR and Machine Learning in Body Image in Bariatrics
A study testing Body Image Counselling with Virtual Reality in people with Obesity (Disorder) and Body Image, run by Imperial College London at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Obesity (Disorder), Body Image, Mental Health
- What is being tested?
- Body Image Counselling with Virtual Reality
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Jun 2026to Mar 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Tier 4 bariatric group
- On waiting list for bariatric metabolic surgery
- Able to stand unaided for at least 5 minutes
Who cannot join
- Anyone who cannot provide informed consent
- Anyone who is involved in current research or has recently been involved in any research prior to recruitment.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United Kingdom1 site
Imperial College London
London
Nazrin Assaf, n.assaf21@imperial.ac.uk
About this study
Official title: 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.
Read more
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.
- Conditions
- Obesity (Disorder), Body Image, Mental Health, Bariatric Surgery
- Being tested
- Body Image Counselling with Virtual Reality
- Keywords
- 3D Reconstruction, Virtual Reality, Body Image, Machine Learning, Bariatric Metabolic Surgery
- Medical subject headings
- Obesity, Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Body Image Counselling with Virtual RealityBehavioural
Body image counselling using personalised 3D reconstructed images of participant with 15% and 25% total body weight loss in a virtual reality environment.
| Study group | Role | What they receive |
|---|---|---|
| Control Group | No intervention | Body Image Counselling without Virtual Reality |
| Intervention Group | Experimental | Body Image Counselling with Virtual Reality Receives: Behavioral: Body Image Counselling with Virtual Reality |
What is being measured
The primary outcome is the main question the study is designed to answer.
Body Weight
kg
Measured: 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
Measured: 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
Measured: 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
Measured: Baseline, and through study completion, an average of 3 years
Secondary outcomes (1)
Participant opinion on virtual reality environments.
Qualitative data based on discussions and feedback held during group sessions.
Measured: Duration of body image counselling sessions, average of 6 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2026
- Study startJun 2026 (estimated)
- Primary completionDec 2029 (estimated)
- Study completionMar 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obesity (Disorder)Studies of the same condition, open and under way.
- More trials run by Imperial College LondonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Imperial College London
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07668492
- Sponsor's protocol ID
- 181865
- Status last verified
- Jun 2026
- First submitted
- 15 Jun 2026
- Last updated
- 25 Jun 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Use of 3D Reconstruction, Virtual Reality, and Machine Learning in Addressing Body Image in Bariatric Metabolic Surgery.
- ClinicalTrials.gov ID
- NCT07668492
- Acronym / sponsor ID
- 181865
- Conditions
- Obesity (Disorder), Body Image, Mental Health, Bariatric Surgery
- Keywords
- 3D Reconstruction, Virtual Reality, Body Image, Machine Learning, Bariatric Metabolic Surgery
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Imperial College LondonUniversity, hospital or other
- Study start
- Jun 2026 (estimated)
- Primary completion
- Dec 2029 (estimated)
- Study completion
- Mar 2030 (estimated)
- First posted
- 25 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control Group | No intervention | –Body Image Counselling without Virtual Reality |
| Intervention Group | Experimental | Behavioral: Body Image Counselling with Virtual RealityBody Image Counselling with Virtual Reality |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Tier 4 bariatric group
- On waiting list for bariatric metabolic surgery
- Able to stand unaided for at least 5 minutes
Key exclusion criteria (2 listed)
- Anyone who cannot provide informed consent
- Anyone who is involved in current research or has recently been involved in any research prior to recruitment.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Body Image Counselling with Virtual RealityBody image counselling using personalised 3D reconstructed images of participant with 15% and 25% total body weight loss in a virtual reality environment. | Behavioural | Intervention Group |
Primary outcome
Body Weight
Time frame: Baseline and through study completion, an average of 3 years.
kg
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
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
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
1 secondary outcome
Participant opinion on virtual reality environments.
Time frame: Duration of body image counselling sessions, average of 6 months.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jun 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Body Image Counselling with Virtual Reality in people with Obesity (Disorder) and Body Image, run by Imperial College London at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 25 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Nazrin Assaf (+44 (0) 203 315 8231, n.assaf21@imperial.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Body Weight (time frame: Baseline and through study completion, an average of 3 years.). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jun 2026.