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

NCT04630184 | Unknown

• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (5)

• Social physical anxiety change (0-12 weeks)

  Before and after intervention (Baseline and after 12 weeks)

• Adherence to the physical activity (PA) intervention

  At the end of the PA intervention (after 12 weeks)

• Compliance with the PA intervention

  At the end of the PA intervention (after 12 weeks)

• Physical activity change (0-12 weeks)

  Before and after intervention (Baseline and after 12 weeks)

• 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)

Other Outcomes (16)

• Propensity to immersion

  Before the intervention (baseline)

• The feeling of presence in immersion the feeling of presence in immersion

  after each virtual reality session (weeks 1, 2, 3, 4, 5,6 , 9 amd 12)

• Cybermalaise

  before and after each virtual reality session (weeks 1, 2, 3, 4, 5,6 , 9 amd 12)

Study Arms (3)

Virtual reality and exercice

EXPERIMENTAL

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

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

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

Interventions

Exposure intervention in virtual reality 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

Virtual reality and exercice

Exercise 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; Virtual reality and exercice

Placebo 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

Placebo and exercice

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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).

Sponsors & Collaborators

• Universite du Quebec en Outaouais: lead

Study Sites (1)

UQO

Gatineau, Quebec, J8X 3X7, Canada

RECRUITING

MeSH Terms

Conditions

Obesity; Motor Activity

Interventions

Exercise

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Central Study Contacts

aurelie Baillot

CONTACT

8199437561; aurelie.baillot@uqo.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: The reserarch assistant (for assesement) will be blind of the group allocation, as well as the kinesiologist (but not the psychologist).
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: November 3, 2020
• First Posted: November 16, 2020
• Study Start: September 1, 2021
• Primary Completion: March 31, 2023
• Study Completion: December 31, 2023
• Last Updated: November 3, 2022

Record last verified: 2022-10

Locations

CA (1)