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

Study Overview
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Brief Summary
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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
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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.

Official Title
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Development and Impact of a Virtual Reality Exposure Intervention on Social Physical Anxiety During Physical Activity in Women With Obesity

Conditions
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Obesity, Exercise, Virtual Reality

Intervention / Treatment
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* Behavioral: Exposure intervention in virtual reality
* Behavioral: Exercise
* Behavioral: Placebo


Participation Criteria
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Eligibility Criteria
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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).

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Virtual reality and exercice<br>This group will receive the exposure intervention in virtual reality and physical activity during 12 weeks | Behavioral: Exposure intervention in virtual reality<br>* 6 sessions of 45 minutes weekly and 2 follow-up meetings (3 and 6 weeks after the weekly follow-up) with cognitive restructuring and VR exposure supervised by psychologists<br>Behavioral: Exercise<br>* Participants will have to go twice a week, for 12 weeks to carry out 2 individual endurance training sessions of 45 minutes (moderate to vigorous intensity), supervised by a kinesiologist. Participants will also have to complete a 3rd 60-minute endurance session at home (or two 30-minute sessions).<br>|
| Placebo Comparator: Placebo and exercice<br>This group will receive the placebo intervention (relaxation) and physical activity during 12 weeks | Behavioral: Exercise<br>* Participants will have to go twice a week, for 12 weeks to carry out 2 individual endurance training sessions of 45 minutes (moderate to vigorous intensity), supervised by a kinesiologist. Participants will also have to complete a 3rd 60-minute endurance session at home (or two 30-minute sessions).<br>Behavioral: Placebo<br>* 6 sessions of 45 minutes weekly and 2 follow-up meetings (3 and 6 weeks after the weekly follow-up) Discussion around social physical anxiety, stress management (relaxation and breathing) supervised by psychologists<br>|
| No Intervention: waiting list<br>This group will receive no intervention during 12 weeks, then will be randomized in the experimental or placebo group | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Feasibility of the protocol and the intervention | The feasibility of the protocol will be assessed at the end of the study using the following criteria: i) the recruitment rate (number of participants recruited per month), ii) the retention rate (number of participants who have completed all the assessments and focus group and reason for dropout), iii) percentage of missing data (number of missing data out of number of total data) and iv) acceptance of randomization. The feasibility of the intervention will be evaluated at the end of the study using the following criteria: v) the participation rate (number of eligible participants who agreed to participate in the study), vi) the participation rate adherence (number of participants who completed the 8 psychological intervention sessions), vii) the attrition rate (number of participants who abandoned the psychological intervention and reasons). The achievement of the following criteria will be considered as a success factor in terms of feasibility (14, 23): i) recruitment rate ≤ 5.6, | At the end of the study (+ 36 weeks) | 
| Acceptability of the protocol and the intervention | The acceptability of the protocol and the intervention will be qualitatively assessed through 5 to 7 semi-structured discussion groups by teleconference via the zoom platform. The participants will be interviewed for 75 minutes in sub-groups of 6 to 8 participants on their perception, opinion and experience regarding the intervention and the implementation of the protocol (barriers, facilitators, satisfaction, perceived benefits, recommendation and improvement). An interview guide constructed for the purpose of the study will ensure consistency of the themes explored between the different groups while guiding the group facilitation. | At the end of the intervention (+ 12 weeks) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Social physical anxiety change (0-12 weeks) | Social physical anxiety scale (validated questionnaire) | Before and after intervention (Baseline and after 12 weeks) | 
| Adherence to the physical activity (PA) intervention | Adherence to the PA intervention will be calculated as a percentage from the total number of sessions performed out of the 36 prescribed sessions (frequency). | At the end of the PA intervention (after 12 weeks) | 
| Compliance with the PA intervention | Compliance with the PA intervention will be calculated as a percentage from the number of sessions for which the participant will have prescribed the prescription compared to all sessions. For these calculations, data from heart rate monitors worn by participants during PA sessions and diaries completed by participants and the kinesiologist will be used. | At the end of the PA intervention (after 12 weeks) | 
| Physical activity change (0-12 weeks) | Triaxial accelerometer (Actigraph® wGT3X-BT) worn on the hip for 7 days | Before and after intervention (Baseline and after 12 weeks) | 
| Persistance in the practice of PA after the intervention | Triaxial accelerometer (Actigraph® wGT3X-BT) worn on the hip for 7 days | Immediately after the intervention and at the end of the study (after 12 weeks and 36 weeks) |