Virtual Reality and 3D Reconstruction in Body Image and Bariatrics

September 14, 2022 updated by: Imperial College London

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

10

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: SUPPORTIVE_CARE
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Questionnaire to assess acceptability and Feasibility of Virtual Reality and 3d Reconstruction in Body Image and Bariatric Surgery
Time Frame: 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.
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Imperial College London

Investigators

  • Principal Investigator: Fernando Bello, PhD, Imperial College London

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

July 13, 2022

Primary Completion (ANTICIPATED)

September 30, 2022

Study Completion (ANTICIPATED)

September 30, 2022

Study Registration Dates

First Submitted

March 1, 2022

First Submitted That Met QC Criteria

March 1, 2022

First Posted (ACTUAL)

March 10, 2022

Study Record Updates

Last Update Posted (ACTUAL)

September 16, 2022

Last Update Submitted That Met QC Criteria

September 14, 2022

Last Verified

September 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 312801
  • 22IC7677 (OTHER: Imperial College London)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

As this is a pilot study with only 10 participants, individual participant data will not be made available to other researchers. The results will be checked by the sponsor - Imperial College London

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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