NCT05273515

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
10

participants targeted

Target at below P25 for not_applicable obesity

Timeline
Completed

Started Jul 2022

Shorter than P25 for not_applicable obesity

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 1, 2022

Completed
9 days until next milestone

First Posted

Study publicly available on registry

March 10, 2022

Completed
4 months until next milestone

Study Start

First participant enrolled

July 13, 2022

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2022

Completed
Last Updated

September 16, 2022

Status Verified

September 1, 2022

Enrollment Period

3 months

First QC Date

March 1, 2022

Last Update Submit

September 14, 2022

Conditions

Keywords

Virtual Reality3D ReconstructionBariatric Surgery

Outcome Measures

Primary Outcomes (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.

    6 months

Study Arms (1)

Pilot

EXPERIMENTAL

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

Interventions

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

Pilot

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

St Mary's Hospital

London, W2 1NY, United Kingdom

RECRUITING

Related Publications (10)

  • 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.

    PMID: 22027328BACKGROUND
  • 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.

    PMID: 30760932BACKGROUND
  • 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.

    PMID: 31992997BACKGROUND
  • 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.

    PMID: 29900655BACKGROUND
  • 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.

    PMID: 24058109BACKGROUND
  • 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.

    PMID: 23192683BACKGROUND
  • 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.

    PMID: 32309406BACKGROUND
  • 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.

    PMID: 26217507BACKGROUND
  • 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.

    PMID: 34158129BACKGROUND
  • 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.

    PMID: 26430819BACKGROUND

Related Links

MeSH Terms

Conditions

ObesityBody Dysmorphic Disorders

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsSomatoform DisordersMental Disorders

Study Officials

  • Fernando Bello, PhD

    Imperial College London

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Model Details: Pilot study
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 1, 2022

First Posted

March 10, 2022

Study Start

July 13, 2022

Primary Completion

September 30, 2022

Study Completion

September 30, 2022

Last Updated

September 16, 2022

Record last verified: 2022-09

Data Sharing

IPD Sharing
Will not share

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

Locations