Clinical Efficacy of a Virtual Reality Tool for the Treatment of Obesity

Obesity, Morbid Clinical Trial

— SOCRATES  

Official title:

Clinical Efficacy of a Virtual Reality Tool for the Treatment of Obesity (SOCRATES)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05094557
• Other study ID #: SOCRATES_RCT/2021
• Secondary ID: 951930
• Status: Recruiting
• Phase: N/A
• Start date: January 31, 2022
• Est. completion date: October 2022

Study information

• Verified date: April 2022
• Source: Hospital Universitari Vall d'Hebron Research Institute
• Contact: Dimitra Anastasiadou, PhD
• Phone: +34 677871092
• Email: dimitra.anastasiadou[@]vhir.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The objective of the study, which is framed within European Union's H2020 project titled SOCRATES, is to assess the clinical efficacy of a Virtual Reality (VR) embodiment tool for treating obesity and to compare it to usual care, through a Randomized Controlled Trial

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 96
• Est. completion date: October 2022
• Est. primary completion date: October 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• BMI = 30 kg/m2 and = 55 kg/m2.

• Receiving ambulatory treatment at the Vall d´Hebron University Hospital.

• No concurrent involvement in other treatment related to the obesity condition.

• Minimal digital skills and able to use a proper digital device (Smartphone, tablet, computer).

• Oral and written understanding of the Spanish language to complete the questionnaires and use the system.

• Acceptance to sign the informed consent to participate.

Exclusion Criteria:

• Body Mass Index > 45.

• Presence of an Eating Disorder during the last 2 years.

• Non-stabilised severe mental disorder that could interfere with the successful implementation of the research protocol (i.e. psychosis, depression with suicidal risk, alcohol or drug abuse, psychotic or manic symptoms).

• Auditory or visual complications that might affect the participant during exposure to the VR platform.

• Intellectual disability or any major illness seriously affecting cognitive performance (i.e. neurological disorders).

• Personal history of epilepsy.

Related Conditions & MeSH terms

• Obesity
• Obesity, Morbid

Intervention

Behavioral:
• Experimental Group 1: Body swapping VR intervention + psychoeducational video + Treatment As usual
The patient will be embodied in his/her own avatar and will maintain a conversation with a counsellor's avatar of his/her choice. Once the experiment starts, the patient, embodied in his/her own body, will start describing his/her problem in terms of subjective experiences of being obese in daily life. Then, he/she will be body swapped to the counsellor's body and try to respond to the problem just manifested by the patient. The crucial aspect here is that the patient, from the counsellor's viewpoint, will see a representation of his/her real body when looking at the patient's avatar speaking and moving. Therefore, the patient will have the opportunity to see himself/herself in first person (1PP) and second person (2PP) perspectives.
• Experimental Group 2: VR intervention without body swapping + psychoeducational video + Treatment As usual
Participants from the Experimental Group 2 will be embodied in their own body and will participate in "pre-established discourse" provided by the chosen counsellor, who will ask about the perceived barriers for engagement with a healthier lifestyle and will give practical recommendations about how to achieve a healthier and happier life, in terms of healthy eating and physical activity. No body swapping will take place for this group. Participants will also continue receiving Treatment As usual plus a Psychoeducational video with useful information about how to engage with a healthier lifestyle.
• Control Group: Psychoeducational video + Treatment As usual
Participants from the Control Group will receive their Treatment As Usual plus a Psychoeducational video. Treatment as usual will consist of regular medical, nutritional and/or psychiatric follow-ups with the obesity specialists of the Vall d´ Hebron University Hospital and standard routine tests. These visits aim to provide practical recommendations about how to achieve a gradual weight loss and engage more with physical exercise.

Locations

Country	Name	City	State
Spain	Vall d'Hebron University Hospital, Psychiatry Department; Vall d'Hebron Institute of Research	Barcelona

Sponsors (2)

Lead Sponsor	Collaborator
Hospital Universitari Vall d'Hebron Research Institute	European Commission

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Adherence and satisfaction with the VR platform I	Suitability Evaluation Questionnaire (SEQ). The SEQ is a 14-item questionnaire designed to measure satisfaction, acceptance and security of use in VR systems and it was specifically designed for rehabilitation systems using VR. Thirteen questions of the SEQ are based on a 6-point Likert scale plus a last open-ended question offering participants the possibility to add comments, if necessary. The global score of SEQ ranges from 13 (poor suitability) to 65 (excellent suitability).	Post-Experiment1 (week 3); Post-Experiment2 (week 4)- Post-Experiment1; Post-Experiment3 (week 5)- Post-Experiment1; Post-Intervention (week 6)- Post-Experiment1
Other	Adherence and satisfaction with the VR platform II	Body Ownership questionnaire does a subjective rating of the illusion of body ownership during the virtual experience through 4 questions that use a 7-point Likert scale, where -3 means "not at all" and +3 "very much" (1. body ownership when looking down; 2. body ownership when looking at the mirror; 3. body ownership when moving; 4. self recognition).	Post-Experiment1 (week 3); Post-Experiment2 (week 4)- Post-Experiment1; Post-Experiment3 (week 5)- Post-Experiment1; Post-Intervention (week 6)- Post-Experiment1
Other	Adherence and satisfaction with the VR platform III	User experiment and feedback (qualitative / interview)	Post-Experiment1 (week 3); Post-Experiment2 (week 4); Post-Experiment3 (week 5); Post-Intervention (week 6)
Primary	Readiness to change I	Readiness Rulers are Visual Analogue Scales ranging from 1 to 10 that assess "Importance", "Confidence" and "Readiness" to change. For the present study, these 3 variables will be measured in terms of a) achieving a healthy weight and b) exercising more, while the "Readiness" scale will be used as critical response primary variable.	Baseline (week 0); Post-Experiment1 (week 3)- Baseline; Post-Experiment2 (week 4)- Baseline; Post-Experiment3 (week 5) - Baseline; Post-Intervention (week 6)- Baseline; 1-week follow-up (week 7)- Baseline; 4-week follow-up (week 10)- Baseline
Primary	Readiness to change II	As a complementary readiness to change measure, the Spanish version of the Stages of Change in Overweight and Obese People (S-Weight) and the Processes of Change in Overweight and Obese People (P-Weight) will be used. Regarding P-Weight, lower scores on this scale reflect no use of a given process of change and higher scores reflect the full use of that process. To make scores from the different subscales comparable, these scores are transformed on a scale ranging from 0 to 100.	Baseline (week 0); Post-Intervention (week 6)- Baseline; 1-week follow-up (week 7)- Baseline; 4-week follow-up (week 10)- Baseline
Secondary	Eating habits I	Three Factor Eating Questionnaire-R18 (TFEQ-R18). The questionnaire assesses three different aspects of eating behaviour: (a) cognitive restraint (CR); (b) uncontrolled eating (UE) and (c) emotional eating (EE). The questionnaire consists of 18 items using a 4-point response scale which ranges from 1 (definitely true) to 4 (definitely false) and items scores are summated into the 3 different subscales: CR, UE and EE. Lower scores show more disordered eating while higher scores show healthier eating behaviour.	Baseline (week 0); Post-Intervention (week 6)- Baseline; 1-week follow-up (week 7)- Baseline; 4-week follow-up (week 10)- Baseline
Secondary	Eating habits II	Lifestyle habits questionnaire. The questionnaire consists of 22 items, each one of which is rated using a 5-poing Likert scale ranging from 1 (Never) to 5 (always), with higher scores indicated better lifestyle habits.	Baseline (week 0); Post-Intervention (week 6)- Baseline; 1-week follow-up (week 7)- Baseline; 4-week follow-up (week 10)- Baseline
Secondary	Psychological well-being I	Hamilton Anxiety and Depression Scale (HADS). The questionnaire consists of 14 items, 7 for anxiety and 7 for depression, and is used to detect the presence and severity of anxiety and depression among people with physical illnesses. The HADS is scored on a 4-point Likert scale ranging from 0 to 3, with the total score ranging from 0 to 42. Higher scores indicate a greater level of distress.	Baseline (week 0); Post-Intervention (week 6)- Baseline; 1-week follow-up (week 7)- Baseline; 4-week follow-up (week 10)- Baseline
Secondary	Psychological well-being II	Body Shape Questionnaire (BSQ). The BSQ is a 10-item self-report instrument, derived from the original 34-item version developed by Cooper, Taylor, Cooper, & Fairbum (1987), which assesses concerns about body shape expressed by clinical and non-clinical samples. It is based on a 6-point Likert scale questions (Never, Rarely, Sometimes, Often, Very Often, and Always) with higher scores indicating higher body dissatisfaction.	Baseline (week 0); Post-Intervention (week 6)- Baseline; 1-week follow-up (week 7)- Baseline; 4-week follow-up (week 10)- Baseline
Secondary	Psychological well-being III	Body Image QoL Inventory (BIQLI-SP). The BIQLI is a 19-item instrument designed to quantify the impact of one's body image experiences on several relevant facets of his/her psychosocial functioning and wellbeing in everyday life. The instrument uses a 7-point bipolar scale ranging from -3 (very negative effect) to 0 (no impact) to +3 (very positive impact), with higher scores indicating better psychological well-being in everyday life.	Baseline (week 0); Post-Intervention (week 6)- Baseline; 1-week follow-up (week 7)- Baseline; 4-week follow-up (week 10)- Baseline
Secondary	Psychological well-being IV	Weight Bias Internalization Scale (WBIS-M). The WBIS-M is a self-report 11-item unidimensional scale that is considered one of the most frequently used instruments for assessing internalized weight stigma across different body weight categories, in both clinical and research settings. Each answer is rated using a 7-point Liker scale, ranging from 1 (Strongly disagree) to 7 (Strongly agree) with higher scores indicating higher internalized weight bias. Items 1 and 9 are reverse scored.	Baseline (week 0); Post-Intervention (week 6)- Baseline; 1-week follow-up (week 7)- Baseline; 4-week follow-up (week 10)- Baseline
Secondary	Body Mass Index	Body Mass Index (kg/m2)	Baseline (week 0); Post-Intervention (week 6)- Baseline; 1-week follow-up (week 7)- Baseline; 4-week follow-up (week 10)- Baseline
Secondary	Cognitive Reserve Questionnaire	The CRQ is a self-report questionnaire developed and validated in Spanish population, which evaluates the degree of Cognitive Reserve (CR) in healthy controls and in patients with early signs of Alzheimer disease. The CRQ is composed of 8 items that assess aspects generally related to cognitive reserve ranges from 0 to 25 and is divided into quartiles. In this way, a score equal to or less than 6 points (= Q1) would show a low CR, between 7 and 9 points (Q1-Q2) would correspond to a low-medium CR, while scores between 10 and 14 (Q2-Q3) would show medium-high CR. Finally, scores = 15 points would be classified as high CR (Q4).	Baseline (week 0)