ObesitySPA-VRNCT04630184
A Virtual Reality Exposure Intervention on Social Physical Anxiety in Women With Obesity
A study testing Exposure intervention in virtual reality and Exercise in people with Obesity and Exercise, run by Universite du Quebec en Outaouais at 1 site in Canada.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Obesity, Exercise, Virtual Reality
- What is being tested?
- Exposure intervention in virtual reality and Exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 45 participants
- Where
- 1 siteCanada
- Study dates
- 1 Sep 2021to 31 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
UQO
Gatineau, Quebec, J8X 3X7
aurelie baillot, phD, (819) 595-3900 ext. 1995, aurelie.baillot@uqo.ca
About this study
Official title: Development and Impact of a Virtual Reality Exposure Intervention on Social Physical Anxiety During Physical Activity in Women With Obesity
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.
Read the 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
- Being tested
- Exposure intervention in virtual reality, Exercise, Placebo
- Medical subject headings
- Obesity, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exposure intervention in virtual realityBehavioural
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
ExerciseBehavioural
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).
PlaceboBehavioural
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
| Study group | Role | What they receive |
|---|---|---|
| Virtual reality and exercice | Experimental | This group will receive the exposure intervention in virtual reality and physical activity during 12 weeks Receives: Behavioral: Exposure intervention in virtual reality; Behavioral: Exercise |
| Placebo and exercice | Placebo comparator | This group will receive the placebo intervention (relaxation) and physical activity during 12 weeks Receives: Behavioral: Exercise; Behavioral: Placebo |
| waiting list | No intervention | This group will receive no intervention during 12 weeks, then will be randomized in the experimental or placebo group |
What is being measured
The primary outcome is the main question the study is designed to answer.
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,
Measured: 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.
Measured: At the end of the intervention (+ 12 weeks)
Secondary outcomes (5)
Social physical anxiety change (0-12 weeks)
Social physical anxiety scale (validated questionnaire)
Measured: 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).
Measured: 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.
Measured: 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
Measured: 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
Measured: Immediately after the intervention and at the end of the study (after 12 weeks and 36 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Nov 2020
- Study start1 Sep 2021
- Primary completion31 Mar 2023 (estimated)
- Study completion31 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Care provider, Outcomes assessor
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universite du Quebec en Outaouais
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aurelie Baillot, Universite du Quebec en Outaouais
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04630184
- Acronym
- SPA-VR
- Status last verified
- Oct 2022
- First submitted
- 3 Nov 2020
- Last updated
- 3 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development and Impact of a Virtual Reality Exposure Intervention on Social Physical Anxiety During Physical Activity in Women With Obesity
- ClinicalTrials.gov ID
- NCT04630184
- Acronym / sponsor ID
- SPA-VR
- Conditions
- Obesity, Exercise, Virtual Reality
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- Universite du Quebec en OutaouaisUniversity, hospital or other
- Study start
- 1 Sep 2021 (actual)
- Primary completion
- 31 Mar 2023 (estimated)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 16 Nov 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Virtual reality and exercice | Experimental | Behavioral: Exposure intervention in virtual reality, Behavioral: ExerciseThis group will receive the exposure intervention in virtual reality and physical activity during 12 weeks |
| Placebo and exercice | Placebo comparator | Behavioral: Exercise, Behavioral: PlaceboThis group will receive the placebo intervention (relaxation) and physical activity during 12 weeks |
| waiting list | No intervention | –This group will receive no intervention during 12 weeks, then will be randomized in the experimental or placebo group |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Exposure intervention in virtual reality6 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 | Behavioural | Virtual reality and exercice |
| ExerciseParticipants 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). | Behavioural | Placebo and exercice, Virtual reality and exercice |
| Placebo6 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 | Behavioural | Placebo and exercice |
Primary outcome
Feasibility of the protocol and the intervention
Time frame: 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,
Acceptability of the protocol and the intervention
Time frame: 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.
5 secondary outcomes
Social physical anxiety change (0-12 weeks)
Time frame: Before and after intervention (Baseline and after 12 weeks)
Adherence to the physical activity (PA) intervention
Time frame: At the end of the PA intervention (after 12 weeks)
Compliance with the PA intervention
Time frame: At the end of the PA intervention (after 12 weeks)
Physical activity change (0-12 weeks)
Time frame: Before and after intervention (Baseline and after 12 weeks)
Persistance in the practice of PA after the intervention
Time frame: Immediately after the intervention and at the end of the study (after 12 weeks and 36 weeks)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exposure intervention in virtual reality and Exercise in people with Obesity and Exercise, run by Universite du Quebec en Outaouais at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 3 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact aurelie Baillot (8199437561, aurelie.baillot@uqo.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility of the protocol and the intervention (time frame: At the end of the study (+ 36 weeks)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Nov 2022.