Virtual Reality and 3D Reconstruction in Body Image and Bariatrics

Sponsor

Imperial College London (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05273515

Collaborator

(none)

Enrollment

Location

Arm

4.5

Anticipated Duration (Months)

2.2

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

With obesity on the rise, the number of metabolic procedures performed annually is also increasing. Bariatric surgery has a significant impact on metabolic disease but also results in significant weight loss. Approximately, 30-40% of excess weight is lost within the first year following surgery. One of the motivating factors for surgery for patients is body image dissatisfaction and the stigmatisation of living with obesity, which is linked to low esteem, anxiety and depression. However, studies have indicated that following bariatric surgery, patients continue to experience dissatisfaction with their new body and identity due to unmet expectations.

The investigators aim is to start addressing body image issues prior to surgery and provide realistic expectations to patients. This study will be focusing on the feasibility and acceptability of 3D image reconstruction and virtual reality as a method of helping bariatric patients manage their expectations and improve body image satisfaction after surgery. Thereby, leading to better quality of life, improved psychological outcomes and prevention of disordered eating, anxiety and depression.

The study will take place at St Mary's Hospital (London) and the West London NHS Trust Bariatric Clinic from March 2022 to September 2022 (7 months). The study aims to recruit 10 participants from the Tier 3 Bariatric Preoperative Group. Once the participant has provided written consent, a photograph of them will be taken using a handheld 3D scanner on a secure password protected device. The images will be processed to produce two reconstructed images, one with 15% less body weight and the second with 25% less body weight. The participants will be divided into groups of 5 and shown their reconstructed images using individual virtual reality headsets. The participants will only have access to their own images. This will be followed up with group peer discussion meetings and questionnaires.

Condition or Disease	Intervention/Treatment	Phase
Obesity Body Image Disorder Bariatric Surgery Candidate	Other: Virtual Reality and 3D Reconstruction	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

10 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Intervention Model Description:

Pilot studyPilot study

Masking:

None (Open Label)

Primary Purpose:

Supportive Care

Official Title:

The Acceptability and Feasibility of 3D Reconstruction and Virtual Reality in Addressing Body Image in Bariatric Surgery

Anticipated Study Start Date :

May 16, 2022

Anticipated Primary Completion Date :

Sep 30, 2022

Anticipated Study Completion Date :

Sep 30, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Pilot 3D scanning of participants. Images used to created 3D reconstruction of 15% and 25% total body weight loss. These are shown to participants using virtual reality. Qualitative outcomes measured using group discussion and questionnaires.	Other: Virtual Reality and 3D Reconstruction Using virtual reality and 3D reconstruction to produce personalise images of what participants may look like after 15% and 25% total weight loss.

Arm

Intervention/Treatment

Experimental: Pilot

3D scanning of participants. Images used to created 3D reconstruction of 15% and 25% total body weight loss. These are shown to participants using virtual reality. Qualitative outcomes measured using group discussion and questionnaires.

Other: Virtual Reality and 3D Reconstruction

Using virtual reality and 3D reconstruction to produce personalise images of what participants may look like after 15% and 25% total weight loss.

Outcome Measures

Primary Outcome Measures

Questionnaire to assess acceptability and Feasibility of Virtual Reality and 3d Reconstruction in Body Image and Bariatric Surgery [6 months]
The primary outcome measure for the study is whether virtual reality and 3D reconstruction is an acceptable and feasible method of providing psychological support to bariatric patients. This will be determined from the responses on the feedback questionnaires. Participants will undertake 3 questionnaires; 1st after 15% less body weight image shown, 2nd after 25% less body weight image shown and 3rd after final peer group meeting.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

In the tier 3 preoperative bariatric group
18 to 75 years old
Male and Female

Exclusion Criteria:

Anyone who cannot provide informed consent.
Anyone with significant mental health instability

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	St Mary's Hospital	London		United Kingdom	W2 1NY

Sponsors and Collaborators

Imperial College London

Investigators

Principal Investigator: Fernando Bello, PhD, Imperial College London

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

Responsible Party:

Imperial College London

ClinicalTrials.gov Identifier:

NCT05273515

Other Study ID Numbers:

312801
22IC7677

First Posted:

Mar 10, 2022

Last Update Posted:

May 16, 2022

Last Verified:

May 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Imperial College London

Virtual Reality

3D Reconstruction

Bariatric Surgery

Additional relevant MeSH terms:

Body Dysmorphic Disorders

Study Results

No Results Posted as of May 16, 2022