Clinical trial NCT04630184: A Virtual Reality Exposure Intervention on Social Physical Anxiety in Women With Obesity
Official title: Development and Impact of a Virtual Reality Exposure Intervention on Social Physical Anxiety During Physical Activity in Women With Obesity
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Obesity
Exercise
Virtual Reality
Lead sponsor: Universite du Quebec en Outaouais
Sponsor class: OTHER
First posted: 2020-11-16
Enrollment: 45
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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).

Primary outcomes:
measure: Feasibility of the protocol and the intervention
timeFrame: At the end of the study (+ 36 weeks)
measure: Acceptability of the protocol and the intervention
timeFrame: At the end of the intervention (+ 12 weeks)
Secondary outcomes:
measure: Social physical anxiety change (0-12 weeks)
timeFrame: Before and after intervention (Baseline and after 12 weeks)
measure: Adherence to the physical activity (PA) intervention
timeFrame: At the end of the PA intervention (after 12 weeks)
measure: Compliance with the PA intervention
timeFrame: At the end of the PA intervention (after 12 weeks)
measure: Physical activity change (0-12 weeks)
timeFrame: Before and after intervention (Baseline and after 12 weeks)
measure: Persistance in the practice of PA after the intervention
timeFrame: Immediately after the intervention and at the end of the study (after 12 weeks and 36 weeks)
Other outcomes:
measure: Propensity to immersion
timeFrame: Before the intervention (baseline)
measure: The feeling of presence in immersion the feeling of presence in immersion
timeFrame: after each virtual reality session (weeks 1, 2, 3, 4, 5,6 , 9 amd 12)
measure: Cybermalaise
timeFrame: before and after each virtual reality session (weeks 1, 2, 3, 4, 5,6 , 9 amd 12)
measure: Sociodemographic data
timeFrame: before the intervention (baseline)
measure: Depressive symptoms
timeFrame: before the intervention (baseline)
measure: Food disorder
timeFrame: before the intervention (baseline)
measure: Weight Bias Internalisation change (0-12 weeks)
timeFrame: Before and after intervention (Baseline and after 12 weeks)
measure: Body composition change (0-12 weeks)
timeFrame: Before and after intervention (Baseline and after 12 weeks)
measure: Body index mass change (0-12 weeks)
timeFrame: Before and after intervention (Baseline and after 12 weeks)
measure: Waist circumference change (0-12 weeks)
timeFrame: Before and after intervention (Baseline and after 12 weeks)
measure: Body Appreciation change (0-12 weeks)
timeFrame: Before and after intervention (Baseline and after 12 weeks)
measure: Perceived pleasure in physical activity in general (0-12 weeks)
timeFrame: Before and after intervention (Baseline and after 12 weeks)
measure: Motivation change (0-12 weeks)
timeFrame: Before and after intervention (Baseline and after 12 weeks)
measure: Affects during exercise change (0-12 weeks)
timeFrame: Before and after intervention (Baseline and after 12 weeks)
measure: Self-efficacy change (0-12 weeks)
timeFrame: Before and after intervention (Baseline and after 12 weeks)
measure: Perception effort change (0-12 weeks)
timeFrame: Before and after intervention (Baseline and after 12 weeks)
Locations:
city: Gatineau
country: Canada
facility: UQO
state: Quebec
Study officials:
References: