NCT04630184: SPA-VR

A Virtual Reality Exposure Intervention on Social Physical Anxiety in Women With Obesity

Status unknown NA Last updated 3 November 2022

What this trial tests

NA trial testing Exposure intervention in virtual reality in Obesity in 45 participants. Status unknown.

Timeline

1 September 2021

Primary endpoint
31 March 2023

31 December 2023

Quick facts

Lead sponsor	Universite du Quebec en Outaouais
Phase	NA
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	treatment
Enrollment	45
Start date	1 September 2021
Primary completion	31 March 2023
Estimated completion	31 December 2023
Sites	1 location across Canada

Drugs / interventions tested

• Exposure intervention in virtual reality
• Exercise
• Placebo

Conditions studied

• Obesity — all drugs for Obesity →
• Exercise — all drugs for Exercise →
• Virtual Reality — all drugs for Virtual Reality →

Sponsor

Universite du Quebec en Outaouais

Who can join

Adults 18 to 45, female only, with Obesity or Exercise. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The objectives of the project are to: i) assess the feasibility and acceptability of the protocol and the VR exposure intervention in women with obesity, and ii) obtain an estimate of the effect of VR exposure intervention associated with an exercise training on SPA, compliance, adherence and persistence to the exercise training, as well as persistence in PA practice in the middle term to calculate the sample size for a future larger randomized controlled trial (RCT) in women with obesity.

A RCT of feasibility will be carried out. Forty-five women with obesity and a high level of SPA will be randomized into one of the following three groups: 1) Exercice and VR exposure (Ex + expo), 2) Exercise and psychological intervention control (Ex + control) or 3) waiting list (WL).

The interventions will have a physical exercise training (identical for all) and a psychology intervention (different according to the condition: VR exposure or control). The feasibility and acceptability of the protocol and the VR exposure intervention will be assessed at the end of the study. SPA, PA practice, anthropometry, internalization of weight bias, body appreciation, perceived pleasure, motivational regulation, self-efficacy, affects as well as perception effort will be evaluated with questionnaires and scales validated before and after the intervention and 6 months after the end of the intervention. Sociodemographic data, depressive symptoms, problematic eating behaviors and propensity to immersion will be assessed during the initial visit only. Adherence, adherence and persistence to the PA program will be calculated at the end of the intervention. Persistence in PA practice will be calculated using data collected immediately after the end of the intervention and 6 months after the intervention.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Validation of a Virtual Environment to Induce State Social Physique Anxiety in Women with Obesity and Social Physique Anxiety.
   Jeanningros A, Baillot A, Corno G, Rivard MC, et al · · 2023 · cited 3× · PMID 37763006 · DOI 10.3390/jcm12186065