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

NCT ID: NCT04630184

Last Updated: 2022-11-03

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 45 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-09-01
• Study Completion Date: 2023-12-31

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.

Conditions

Obesity; Exercise; Virtual Reality

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Virtual reality and exercice

This group will receive the exposure intervention in virtual reality and physical activity during 12 weeks

Group Type: EXPERIMENTAL

Exposure intervention in virtual reality

Intervention Type: BEHAVIORAL

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

Exercise

Intervention Type: BEHAVIORAL

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).

Placebo and exercice

This group will receive the placebo intervention (relaxation) and physical activity during 12 weeks

Group Type: PLACEBO_COMPARATOR

Exercise

Intervention Type: BEHAVIORAL

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).

Placebo

Intervention Type: BEHAVIORAL

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

waiting list

This group will receive no intervention during 12 weeks, then will be randomized in the experimental or placebo group

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Exposure intervention in virtual reality

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

Intervention Type: BEHAVIORAL

Exercise

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).

Intervention Type: BEHAVIORAL

Placebo

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

Intervention Type: BEHAVIORAL

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).

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Universite du Quebec en Outaouais

OTHER

Sponsor Role: lead

Responsible Party

Aurelie Baillot

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

UQO

Gatineau, Quebec, Canada

Site Status: RECRUITING

Countries

Canada

Central Contacts

aurelie Baillot

Role: CONTACT

aurelie.baillot@uqo.ca

8199437561

Facility Contacts

aurelie baillot, phD

Role: primary

aurelie.baillot@uqo.ca

(819) 595-3900 ext. 1995