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ObesityNCT05273515

Virtual Reality and 3D Reconstruction in Body Image and Bariatrics

A study testing Virtual Reality and 3D Reconstruction in people with Obesity and Body Image Disorder, run by Imperial College London at 1 site in United Kingdom.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 75 yearsHealthy volunteers can take part
What is being tested?
Virtual Reality and 3D Reconstruction
Could I receive a placebo?
No, everyone receives an active treatment
How many people
10 participants
Where
1 siteUnited Kingdom
Study dates
13 Jul 2022to 30 Sep 2022
Phase
Interventional
Are there results?
None posted in the registry

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
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

United Kingdom1 site, 1 recruiting

  • St Mary's Hospital

    London, W2 1NY

    Nazrin Assaf, MBBS, 02033158231, n.assaf21@imperial.ac.uk

    Fernando Bello, PhD, 02033158231, f.bello@imperial.ac.uk

    Recruiting

Other trials in United Kingdom

About this study

Official title: 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.

Being tested
Virtual Reality and 3D Reconstruction
Keywords
Virtual Reality, 3D Reconstruction, Bariatric Surgery
Medical subject headings
Obesity, Body Dysmorphic Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Virtual Reality and 3D ReconstructionOther

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

Study groups in NCT05273515
Study groupRoleWhat they receive
PilotExperimental3D 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.
Receives: Other: Virtual Reality and 3D Reconstruction

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Mar 2022
  2. Study start13 Jul 2022
  3. Primary completion30 Sep 2022 (estimated)
  4. Study completion30 Sep 2022 (estimated)

Resources

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
Not applicable
Intervention model
Single group
Model description
Pilot study
Masking
None (open label)
Enrolment
10 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05273515
Sponsor's protocol ID
312801
Other IDs
22IC7677
Status last verified
Sep 2022
First submitted
1 Mar 2022
Last updated
16 Sep 2022
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: 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

Publications

  • 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.

    PubMed 22027328

  • 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.

    PubMed 30760932

  • 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.

    PubMed 31992997

  • 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.

    PubMed 29900655

  • 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.

    PubMed 24058109

  • 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.

    PubMed 23192683

  • 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.

    PubMed 32309406

  • 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.

    PubMed 26217507

  • 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.

    PubMed 34158129

  • 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.

    PubMed 26430819

Questions about this trial

What is this clinical trial studying?

A study testing Virtual Reality and 3D Reconstruction in people with Obesity and Body Image Disorder, 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: status not confirmed, as of the sponsor's last update on 16 Sep 2022. 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?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Questionnaire to assess acceptability and Feasibility of Virtual Reality and 3d Reconstruction in Body Image and Bariatric Surgery (time frame: 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05273515, which also lists 10 linked publications.

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 16 Sep 2022.

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