Virtual Reality and 3D Reconstruction in Body Image and Bariatrics

Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05273515
• Other study ID #: 312801
• Secondary ID: 22IC7677
• Status: Recruiting
• Phase: N/A
• Start date: July 13, 2022
• Est. completion date: September 30, 2022

Study information

• Verified date: September 2022
• Source: Imperial College London
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 10
• Est. completion date: September 30, 2022
• Est. primary completion date: September 30, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Bariatric Surgery Candidate
• Body Dysmorphic Disorders
• Body Image Disorder
• Obesity

Intervention

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.

Locations

Country	Name	City	State
United Kingdom	St Mary's Hospital	London

Sponsors (1)

Lead Sponsor	Collaborator
Imperial College London

Country where clinical trial is conducted

United Kingdom, 

References & Publications (10)

Bianciardi E, Di Lorenzo G, Niolu C, Betrò 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. — View 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. — View Citation

Conceição 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. — View Citation

Cruz-Sáez S, Pascual A, Salaberria K, Etxebarria I, Echeburúa 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. — View 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. Review. — View 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. — View Citation

Legenbauer T, Müller 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. — View Citation

Manzoni GM, Cesa GL, Bacchetta M, Castelnuovo G, Conti S, Gaggioli A, Mantovani F, Molinari E, Cárdenas-López 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	6 months

External Links

•   Bariatric Surgery Register
•   Prevalence of Obesity
•   Treatment of obesity - Percentage weight loss