Obesity, MorbidSOCRATESNCT05094557
Clinical Efficacy of a Virtual Reality Tool for the Treatment of Obesity
A study testing Experimental Group 1: Body swapping VR intervention + psychoeducational video + Treatment As usual and Experimental Group 2: VR intervention without body swapping + psychoeducational video + Treatment As usual in people with Obesity, Morbid, run by Hospital Universitari Vall d'Hebron Research Institute at 1 site in Spain.
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 Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Obesity, Morbid
- What is being tested?
- Experimental Group 1: Body swapping VR intervention + psychoeducational video + Treatment As usual and Experimental Group 2: VR intervention without body swapping + psychoeducational video + Treatment As usual
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 96 participants
- Where
- 1 siteSpain
- Study dates
- 31 Jan 2022to Oct 2022
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Spain1 site, 1 recruiting
- Recruiting
Vall d'Hebron University Hospital, Psychiatry Department; Vall d'Hebron Institute of Research
Barcelona, 08035
Dimitra Anastasiadou, PhD, +34677871092, dimitra.anastasiadou@vhir.org
Dimitra Anastasiadou, PhD
About this study
Official title: Clinical Efficacy of a Virtual Reality Tool for the Treatment of Obesity (SOCRATES)
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
- Conditions
- Obesity, Morbid
- Being tested
- Experimental Group 1: Body swapping VR intervention + psychoeducational video + Treatment As usual, Experimental Group 2: VR intervention without body swapping + psychoeducational video + Treatment As usual, Control Group: Psychoeducational video + Treatment As usual
- Keywords
- Virtual Reality, obesity, Motivational Interviewing, embodiment, psychological treatment
- Medical subject headings
- Obesity, Morbid, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Experimental Group 1: Body swapping VR intervention + psychoeducational video + Treatment As usualBehavioural
Also called EG1
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 usualBehavioural
Also called EG2
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 usualBehavioural
Also called CG
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.
| Study group | Role | What they receive |
|---|---|---|
| Experimental Group 1 | Experimental | Participants 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. Receives: Behavioral: Experimental Group 1: Body swapping VR intervention + psychoeducational video + Treatment As usual |
| Experimental Group 2 | Experimental | Participants 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. Receives: Behavioral: Experimental Group 2: VR intervention without body swapping + psychoeducational video + Treatment As usual |
| Control Group | Active comparator | 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. Receives: Behavioral: Control Group: Psychoeducational video + Treatment As usual |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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
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.
Measured: 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
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.
Measured: 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
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.
Measured: 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
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.
Measured: 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
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.
Measured: 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 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.
Measured: Baseline (week 0); Post-Intervention (week 6)- Baseline; 1-week follow-up (week 7)- Baseline; 4-week follow-up (week 10)- Baseline
Body Mass Index
Body Mass Index (kg/m2)
Measured: Baseline (week 0); Post-Intervention (week 6)- Baseline; 1-week follow-up (week 7)- Baseline; 4-week follow-up (week 10)- Baseline
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).
Measured: Baseline (week 0)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2021
- Study start31 Jan 2022
- Primary completionOct 2022 (estimated)
- Study completionOct 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Obesity, MorbidStudies of the same condition, open and under way.
- More trials run by Hospital Universitari Vall d'Hebron Research InstituteThe sponsor's other registered studies.
- 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 96 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- European Commission
- Responsible party
- Sponsor
- Investigators
- Pilar Lusilla-Palacios, MD, PhD, Principal investigator, Vall d'Hebron University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05094557
- Sponsor's protocol ID
- SOCRATES_RCT/2021
- Other IDs
- 951930
- Acronym
- SOCRATES
- Status last verified
- Apr 2022
- First submitted
- 27 Sep 2021
- Last updated
- 5 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Publications
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.
PubMed 38578667Anastasiadou 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.
PubMed 35732390
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Efficacy of a Virtual Reality Tool for the Treatment of Obesity (SOCRATES)
- ClinicalTrials.gov ID
- NCT05094557
- Acronym / sponsor ID
- SOCRATES / SOCRATES_RCT/2021
- Conditions
- Obesity, Morbid
- Keywords
- Virtual Reality, obesity, Motivational Interviewing, embodiment, psychological treatment
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 96 participants (estimated)
- Lead sponsor
- Hospital Universitari Vall d'Hebron Research InstituteUniversity, hospital or other
- Collaborators
- European Commission
- Study start
- 31 Jan 2022 (actual)
- Primary completion
- Oct 2022 (estimated)
- Study completion
- Oct 2022 (estimated)
- First posted
- 26 Oct 2021 (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 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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Experimental Group 1 | Experimental | Behavioral: Experimental Group 1: Body swapping VR intervention + psychoeducational video + Treatment As usualParticipants 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 | Experimental | Behavioral: Experimental Group 2: VR intervention without body swapping + psychoeducational video + Treatment As usualParticipants 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 comparator | Behavioral: Control Group: Psychoeducational video + Treatment As usualParticipants 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (6 listed)
- 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).
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 |
|---|---|---|
| Experimental Group 1: Body swapping VR intervention + psychoeducational video + Treatment As usualAlso: EG1The 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. | Behavioural | Experimental Group 1 |
| Experimental Group 2: VR intervention without body swapping + psychoeducational video + Treatment As usualAlso: EG2Participants 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. | Behavioural | Experimental Group 2 |
| Control Group: Psychoeducational video + Treatment As usualAlso: CGParticipants 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. | Behavioural | Control Group |
Primary outcome
Readiness to change I
Time frame: 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 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.
Readiness to change II
Time frame: Baseline (week 0); Post-Intervention (week 6)- Baseline; 1-week follow-up (week 7)- Baseline; 4-week follow-up (week 10)- Baseline
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.
8 secondary outcomes
Eating habits I
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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 IV
Time frame: Baseline (week 0); Post-Intervention (week 6)- Baseline; 1-week follow-up (week 7)- Baseline; 4-week follow-up (week 10)- Baseline
Body Mass Index
Time frame: Baseline (week 0); Post-Intervention (week 6)- Baseline; 1-week follow-up (week 7)- Baseline; 4-week follow-up (week 10)- Baseline
Cognitive Reserve Questionnaire
Time frame: Baseline (week 0)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 May 2022.
- Derived from this study: PubMed 38578667Anastasiadou 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.
- Derived from this study: PubMed 35732390Anastasiadou 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.
- Individual participant dataSharing planned: Yes. 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.
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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.
Pilar Lusilla-Palacios, MD, PhD principal investigator
Vall d'Hebron University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Experimental Group 1: Body swapping VR intervention + psychoeducational video + Treatment As usual and Experimental Group 2: VR intervention without body swapping + psychoeducational video + Treatment As usual in people with Obesity, Morbid, run by Hospital Universitari Vall d'Hebron Research Institute at 1 site in Spain.
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 6 inclusion and 6 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 5 May 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 Spain. 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. 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 Dimitra Anastasiadou, PhD (+34 677871092, dimitra.anastasiadou@vhir.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Readiness to change I (time frame: 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). 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?
On the ClinicalTrials.gov record for NCT05094557, which also lists 2 linked publications.
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 5 May 2022; AzTrials last refreshed its copy on 7 Nov 2026.