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A Virtual Reality Exposure Intervention on Social Physical Anxiety in Women With Obesity (SPA-VR)

U

Universite du Quebec en Outaouais

Status

Enrolling

Conditions

Obesity
Virtual Reality
Exercise

Treatments

Behavioral: Placebo
Behavioral: Exercise
Behavioral: Exposure intervention in virtual reality

Study type

Interventional

Funder types

Other

Identifier

Details and patient eligibility

About

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.

Full description

Several studies show that a high level of social physical anxiety (SPA) can lead to avoidance and poor adherence to physical activity (PA) programs. Although this link is known and a high level of SPA is frequently found in women with obesity, no psychological intervention specific to the treatment of SPA has been developed to date. Exposure therapy is the treatment of choice for general social anxiety. However, this format of therapy can cause great discomfort for the patient and prevents complete control of the environment by the clinician. Virtual reality (VR), commonly employed in the treatment of anxiety disorders, offers a solution to these problems by allowing exposure to human stimuli in an adaptable environment and under the control of the clinician, with a reduction in stress patient discomfort.

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.

Enrollment

45 estimated patients

Sex

Female

Ages

18 to 45 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • woman
  • inactive (<150 min. of moderate to vigorous PA / week )
  • aged between 18 and 45 years
  • BMI ≥ 30 kg / m2
  • to be able to go to Université du Québec en Outaouais twice a week

Exclusion criteria

  • to have a low to moderate social physical anxiety level (SPA score <27/45 on the physical and social anxiety scale )
  • suffer from hypersensitivity to motion sickness
  • to be pregnant or plan to become over the next year
  • to take medication that may influence weight
  • to have undergone bariatric surgery
  • to have a contraindication to physical activity
  • to have participated in a physical activity program in the last 6 months supervised
  • to have an intellectual disability, and have a severe and persistent psychiatric problem (psychosis, bipolar disorder).

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

45 participants in 3 patient groups, including a placebo group

Virtual reality and exercice
Experimental group
Description:
This group will receive the exposure intervention in virtual reality and physical activity during 12 weeks
Treatment:
Behavioral: Exposure intervention in virtual reality
Behavioral: Exercise
Placebo and exercice
Placebo Comparator group
Description:
This group will receive the placebo intervention (relaxation) and physical activity during 12 weeks
Treatment:
Behavioral: Placebo
Behavioral: Exercise
waiting list
No Intervention group
Description:
This group will receive no intervention during 12 weeks, then will be randomized in the experimental or placebo group

Trial contacts and locations

1

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Central trial contact

aurelie Baillot

Data sourced from clinicaltrials.gov

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