Clinical Efficacy of a Virtual Reality Tool for the Treatment of Obesity
SOCRATES
2 other identifiers
interventional
96
1 country
1
Brief 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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jan 2022
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 27, 2021
CompletedFirst Posted
Study publicly available on registry
October 26, 2021
CompletedStudy Start
First participant enrolled
January 31, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2022
CompletedMay 5, 2022
April 1, 2022
8 months
September 27, 2021
April 29, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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
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 Outcomes (8)
Eating habits I
Baseline (week 0); Post-Intervention (week 6)- Baseline; 1-week follow-up (week 7)- Baseline; 4-week follow-up (week 10)- Baseline
Eating habits II
Baseline (week 0); Post-Intervention (week 6)- Baseline; 1-week follow-up (week 7)- Baseline; 4-week follow-up (week 10)- Baseline
Psychological well-being I
Baseline (week 0); Post-Intervention (week 6)- Baseline; 1-week follow-up (week 7)- Baseline; 4-week follow-up (week 10)- Baseline
Psychological well-being II
Baseline (week 0); Post-Intervention (week 6)- Baseline; 1-week follow-up (week 7)- Baseline; 4-week follow-up (week 10)- Baseline
Psychological well-being III
Baseline (week 0); Post-Intervention (week 6)- Baseline; 1-week follow-up (week 7)- Baseline; 4-week follow-up (week 10)- Baseline
- +3 more secondary outcomes
Other Outcomes (3)
Adherence and satisfaction with the VR platform I
Post-Experiment1 (week 3); Post-Experiment2 (week 4)- Post-Experiment1; Post-Experiment3 (week 5)- Post-Experiment1; Post-Intervention (week 6)- Post-Experiment1
Adherence and satisfaction with the VR platform II
Post-Experiment1 (week 3); Post-Experiment2 (week 4)- Post-Experiment1; Post-Experiment3 (week 5)- Post-Experiment1; Post-Intervention (week 6)- Post-Experiment1
Adherence and satisfaction with the VR platform III
Post-Experiment1 (week 3); Post-Experiment2 (week 4); Post-Experiment3 (week 5); Post-Intervention (week 6)
Study Arms (3)
Experimental Group 1
EXPERIMENTALParticipants from the Experimental Group 1 will engage in a self-conversation through embodied perspective taking (body swapping), according to which they will be embodied alternately in their own virtual representation and in their counsellor's virtual body. They will also continue receiving Treatment As usual plus a Psychoeducational video with useful information about how to engage with a healthier lifestyle.
Experimental Group 2
EXPERIMENTALParticipants from the Experimental Group 2 will be embodied in their own body and will participate in a "pre-established discourse" provided by their virtual counsellor. 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
ACTIVE COMPARATORParticipants 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.
Interventions
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.
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.
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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Vall d'Hebron University Hospital, Psychiatry Department; Vall d'Hebron Institute of Research
Barcelona, 08035, Spain
Related Publications (2)
Anastasiadou D, Herrero P, Garcia-Royo P, Vazquez-De Sebastian J, Slater M, Spanlang B, Alvarez de la Campa E, Ciudin A, Comas M, Ramos-Quiroga JA, Lusilla-Palacios P. Assessing the Clinical Efficacy of a Virtual Reality Tool for the Treatment of Obesity: Randomized Controlled Trial. J Med Internet Res. 2024 Apr 5;26:e51558. doi: 10.2196/51558.
PMID: 38578667DERIVEDAnastasiadou D, Slater M, Spanlang B, Cano Porras D, Comas M, Ciudin A, Puig GP, Vazquez-De Sebastian J, Ramos-Quiroga JA, Lusilla-Palacios P. Clinical efficacy of a virtual reality tool for the treatment of obesity: study protocol of a randomised controlled trial. BMJ Open. 2022 Jun 22;12(6):e060822. doi: 10.1136/bmjopen-2022-060822.
PMID: 35732390DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Pilar Lusilla-Palacios, MD, PhD
Vall d'Hebron University Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 27, 2021
First Posted
October 26, 2021
Study Start
January 31, 2022
Primary Completion
October 1, 2022
Study Completion
October 1, 2022
Last Updated
May 5, 2022
Record last verified: 2022-04
Data Sharing
- IPD Sharing
- Will share
The data that support the findings of this study will be available on request from the corresponding author once the study is published. The data are not publicly available due to the sensitivity of participants´data.