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Virtual Reality and 3D Reconstruction in Body Image and Bariatrics

Primary Purpose

Obesity, Body Image Disorder, Bariatric Surgery Candidate

Status
Recruiting
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Virtual Reality and 3D Reconstruction
Sponsored by
Imperial College London
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Obesity focused on measuring Virtual Reality, 3D Reconstruction, Bariatric Surgery

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • St Mary's HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Pilot

Arm Description

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.

Outcomes

Primary Outcome Measures

Questionnaire to assess acceptability and Feasibility of Virtual Reality and 3d Reconstruction in Body Image and Bariatric Surgery
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.

Secondary Outcome Measures

Full Information

First Posted
March 1, 2022
Last Updated
September 14, 2022
Sponsor
Imperial College London
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1. Study Identification

Unique Protocol Identification Number
NCT05273515
Brief Title
Virtual Reality and 3D Reconstruction in Body Image and Bariatrics
Official Title
The Acceptability and Feasibility of 3D Reconstruction and Virtual Reality in Addressing Body Image in Bariatric Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
September 2022
Overall Recruitment Status
Recruiting
Study Start Date
July 13, 2022 (Actual)
Primary Completion Date
September 30, 2022 (Anticipated)
Study Completion Date
September 30, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Imperial College London

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity, Body Image Disorder, Bariatric Surgery Candidate
Keywords
Virtual Reality, 3D Reconstruction, Bariatric Surgery

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Pilot study
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Pilot
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Virtual Reality and 3D Reconstruction
Intervention Description
Using virtual reality and 3D reconstruction to produce personalise images of what participants may look like after 15% and 25% total weight loss.
Primary Outcome Measure Information:
Title
Questionnaire to assess acceptability and Feasibility of Virtual Reality and 3d Reconstruction in Body Image and Bariatric Surgery
Description
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.
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Fernando Bello, PhD
Organizational Affiliation
Imperial College London
Official's Role
Principal Investigator
Facility Information:
Facility Name
St Mary's Hospital
City
London
ZIP/Postal Code
W2 1NY
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nazrin Assaf, MBBS
Phone
02033158231
Email
n.assaf21@imperial.ac.uk
First Name & Middle Initial & Last Name & Degree
Fernando Bello, PhD
Phone
02033158231
Email
f.bello@imperial.ac.uk

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing 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
Citations:
PubMed Identifier
22027328
Citation
Ionut V, Bergman RN. Mechanisms responsible for excess weight loss after bariatric surgery. J Diabetes Sci Technol. 2011 Sep 1;5(5):1263-82. doi: 10.1177/193229681100500536.
Results Reference
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PubMed Identifier
30760932
Citation
Bianciardi E, Di Lorenzo G, Niolu C, Betro S, Zerbin F, Gentileschi P, Siracusano A. Body image dissatisfaction in individuals with obesity seeking bariatric surgery: exploring the burden of new mediating factors. Riv Psichiatr. 2019 Jan-Feb;54(1):8-17. doi: 10.1708/3104.30935.
Results Reference
background
PubMed Identifier
31992997
Citation
Legenbauer T, Muller A, de Zwaan M, Herpertz S. Body Image and Body Avoidance Nine Years After Bariatric Surgery and Conventional Weight Loss Treatment. Front Psychiatry. 2020 Jan 14;10:945. doi: 10.3389/fpsyt.2019.00945. eCollection 2019.
Results Reference
background
PubMed Identifier
29900655
Citation
Ivezaj V, Grilo CM. The complexity of body image following bariatric surgery: a systematic review of the literature. Obes Rev. 2018 Aug;19(8):1116-1140. doi: 10.1111/obr.12685. Epub 2018 Jun 13.
Results Reference
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PubMed Identifier
24058109
Citation
Cruz-Saez S, Pascual A, Salaberria K, Etxebarria I, Echeburua E. Risky eating behaviors and beliefs among adolescent girls. J Health Psychol. 2015 Feb;20(2):154-63. doi: 10.1177/1359105313500683. Epub 2013 Sep 20.
Results Reference
background
PubMed Identifier
23192683
Citation
Conceicao E, Orcutt M, Mitchell J, Engel S, Lahaise K, Jorgensen M, Woodbury K, Hass N, Garcia L, Wonderlich S. Eating disorders after bariatric surgery: a case series. Int J Eat Disord. 2013 Apr;46(3):274-9. doi: 10.1002/eat.22074. Epub 2012 Nov 29.
Results Reference
background
PubMed Identifier
32309406
Citation
Caltabiano ML. Translational aspects of body image research for obesity-related quality of life and weight loss maintenance post-bariatric surgery. Ann Transl Med. 2020 Mar;8(Suppl 1):S2. doi: 10.21037/atm.2019.09.63.
Results Reference
background
PubMed Identifier
26217507
Citation
Ratcliffe D, Ali R, Ellison N, Khatun M, Poole J, Coffey C. Bariatric psychology in the UK National Health Service: input across the patient pathway. BMC Obes. 2014 Aug 30;1:20. doi: 10.1186/s40608-014-0020-6. eCollection 2014.
Results Reference
background
PubMed Identifier
34158129
Citation
Phelan S, Peruvemba S, Levinson D, Stulberg N, Lacy A, Legato M, Werner JP. Feasibility of a virtual reality-based approach to improve behavioral weight management outcomes. Pilot Feasibility Stud. 2021 Jun 22;7(1):129. doi: 10.1186/s40814-021-00865-5.
Results Reference
background
PubMed Identifier
26430819
Citation
Manzoni GM, Cesa GL, Bacchetta M, Castelnuovo G, Conti S, Gaggioli A, Mantovani F, Molinari E, Cardenas-Lopez G, Riva G. Virtual Reality-Enhanced Cognitive-Behavioral Therapy for Morbid Obesity: A Randomized Controlled Study with 1 Year Follow-Up. Cyberpsychol Behav Soc Netw. 2016 Feb;19(2):134-40. doi: 10.1089/cyber.2015.0208. Epub 2015 Oct 2.
Results Reference
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Links:
URL
https://digital.nhs.uk/data-and-information/publications/statistical/health-survey-for-england/2019/health-survey-for-england-2019-data-tables
Description
Prevalence of Obesity
URL
https://e-dendrite.com/Publishing/Reports/Bariatric/NBSR2020.pdf
Description
Bariatric Surgery Register

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Virtual Reality and 3D Reconstruction in Body Image and Bariatrics

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