Impact of the Use of VERT on Body Image After Bariatric Surgery

NCT05460104 | Active Not Recruiting

• 1 other identifier: CHUBX 2021/37
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 2

Brief Summary

The purpose ot the study is to assess the effectiveness of the use of VERT on improving body image at 12 months in patients who underwent bariatric surgery in the weight stabilization phase (between 18 and 30 months after bariatric) presenting dissatisfaction with their body image compared to standard follow-up in post-bariatric surgery (lack of specific management of body image).

Conditions

Obesity; Bariatric Surgery Candidate

Keywords

Virtual Reality Exposure Therapy; Body image; Dysmorphophobia

Outcome Measures

Primary Outcomes (1)

• Body Shape Questionnaire

  Average variation of the Body Shape Questionnaire (BSQ). BSQ is a 34 questions questionnaire, for each question the answer is 1 to 6, 1 for "never" and 6 for "always". (score ≥ 111, moderate body image concern)

  Between inclusion and 12 months after.

Secondary Outcomes (8)

• Change weight

  Between inclusion day and Month 3

• Change weight

  Between Month 6 and Month 12

• Body Image Assessment for Obesity questionnaire

  Between inclusion day and Month 3

• Body Image Assessment for Obesity questionnaire

  Between Month 6 and Month 12

• Quality of Life, Obesity and Dietetics questionnaire assess quality of life

  Between inclusion day and Month 3

Study Arms (2)

Expérimental

EXPERIMENTAL

Virtual Reality Exposure Therapy will be realised.

Device: Experimental

Control

ACTIVE COMPARATOR

Standard care without VRET

Other: Control

Interventions

Experimental DEVICE

Virtual reality sessions with a psychologist (30 minutes per session) once a week for 10 weeks. Work of the psychologist on a virtual environment created for the protocol in partnership with the company.

Expérimental

Control OTHER

Standard care is medical follow-up, no specific psychological care.

Control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

Sponsors & Collaborators

• University Hospital, Bordeaux: lead

Study Sites (2)

CH de Libourne - Hôpital Robert BOULIN

Libourne, 33500, France

Location

CHU de Bordeaux - Hopital Haut-Lévêque

Pessac, 33604, France

Location

MeSH Terms

Conditions

Obesity; Body Dysmorphic Disorders

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Somatoform Disorders; Mental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 15, 2022
• First Posted: July 15, 2022
• Study Start: March 12, 2024
• Primary Completion (Estimated): December 19, 2026
• Study Completion (Estimated): December 19, 2026
• Last Updated: January 15, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

FR (2)