A Virtual Reality Exposure Intervention on Social Physical Anxiety in Women With Obesity
- Conditions
- ExerciseObesityVirtual Reality
- Interventions
- Behavioral: Exposure intervention in virtual realityBehavioral: ExerciseBehavioral: Placebo
- Registration Number
- NCT04630184
- Lead Sponsor
- Universite du Quebec en Outaouais
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- Female
- Target Recruitment
- 45
- 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
- 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).
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Virtual reality and exercice Exposure intervention in virtual reality This group will receive the exposure intervention in virtual reality and physical activity during 12 weeks Virtual reality and exercice Exercise This group will receive the exposure intervention in virtual reality and physical activity during 12 weeks Placebo and exercice Placebo This group will receive the placebo intervention (relaxation) and physical activity during 12 weeks Placebo and exercice Exercise This group will receive the placebo intervention (relaxation) and physical activity during 12 weeks
- Primary Outcome Measures
Name Time Method Acceptability of the protocol and the intervention At the end of the intervention (+ 12 weeks) 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.
Feasibility of the protocol and the intervention At the end of the study (+ 36 weeks) 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,
- Secondary Outcome Measures
Name Time Method Adherence to the physical activity (PA) intervention At the end of the PA intervention (after 12 weeks) 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).
Social physical anxiety change (0-12 weeks) Before and after intervention (Baseline and after 12 weeks) Social physical anxiety scale (validated questionnaire)
Compliance with the PA intervention At the end of the PA intervention (after 12 weeks) 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.
Physical activity change (0-12 weeks) Before and after intervention (Baseline and after 12 weeks) Triaxial accelerometer (Actigraph® wGT3X-BT) worn on the hip for 7 days
Persistance in the practice of PA after the intervention Immediately after the intervention and at the end of the study (after 12 weeks and 36 weeks) Triaxial accelerometer (Actigraph® wGT3X-BT) worn on the hip for 7 days
Trial Locations
- Locations (1)
UQO
🇨🇦Gatineau, Quebec, Canada