Recruiting

Virtual Reality

Sponsor:

Universite du Quebec en Outaouais

Code:

NCT04630184

Conditions

Obesity

Exercise

Virtual Reality

Eligibility Criteria

Sex: Female

Age: 18 - 45

Healthy Volunteers: Not accepted

Interventions

Exposure intervention in virtual reality

Exercise

Placebo

Study Details

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.

Conditions

Obesity

Exercise

Virtual Reality

Study ID

NCT04630184

Start date

Sep 1, 2021

Status verified date

Oct, 2022

Completion date

Dec 31, 2023

Anticipated

Primary completion date

Mar 31, 2023

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18 - 45

Healthy Volunteers: Not accepted

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).

Study Design

Enrollment

45 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Virtual reality and exercice

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

placebo comparator: Placebo and exercice

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

no intervention: waiting list

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

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).

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

Primary outcome measure

  • Feasibility of the protocol and the intervention [ Time Frame: At the end of the study (+ 36 weeks) ]
  • Acceptability of the protocol and the intervention [ Time Frame: At the end of the intervention (+ 12 weeks) ]

Central Contacts and Locations

Central contacts

aurelie Baillot

8199437561aurelie.baillot@uqo.ca

Locations

UQO

Recruiting

Gatineau, Quebec, Canada, J8X 3X7

Contacts

aurelie baillot, phD

(819) 595-3900aurelie.baillot@uqo.ca

More Information

Sponsor

Universite du Quebec en Outaouais

Last update posted

Nov 3, 2022

Last verified

Oct, 2022

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Universite du Quebec en Outaouais on 2022-11-03.