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SOCRATESVirtual Reality Tool for Obesity Treatment: A Clinical Efficacy Study

Study Aim

This study aims to evaluate the effectiveness of a Virtual Reality tool in increasing your readiness to change towards achieving a healthy weight and exercising more, using measures such as Readiness Rulers and the Spanish version of the Stages and Processes of Change in Overweight and Obese People.

What is 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

Behavioral

Who is being recruted

Body Weight+6

+ Nutrition Disorders

+ Nutritional and Metabolic Diseases

From 18 to 65 Years

+12 Eligibility Criteria

See all eligibility criteria

How is the trial designed

Treatment Study

Interventional

Study Start: January 2022

See protocol details

Summary

Principal SponsorHospital Universitari Vall d'Hebron Research Institute

Study ContactDimitra Anastasiadou, PhD

Last updated: January 28, 2026

Sourced from a government-validated database.Claim as a partner

Study start date: January 31, 2022

Actual date on which the first participant was enrolled.

This study is part of the European Union's H2020 project, SOCRATES, and it aims to evaluate the effectiveness of a Virtual Reality (VR) tool in treating obesity. The focus is on comparing this new VR approach to traditional care methods. The study is specifically designed for individuals struggling with obesity. The importance of this research lies in its potential to introduce a new, innovative method for obesity treatment, which could improve care and address current challenges in weight management. During the study, participants will use a VR tool designed to help them manage their weight. The effectiveness of this tool will be measured using 'Readiness Rulers', which are scales ranging from 1 to 10. These scales assess the participant's 'Importance', 'Confidence', and 'Readiness' to change in terms of achieving a healthy weight and exercising more. Additionally, the Spanish version of the 'Stages of Change in Overweight and Obese People' and the 'Processes of Change in Overweight and Obese People' will be used. These tools help understand the participant's stage of change and their use of different processes to manage their weight. The study's primary focus is on the 'Readiness' scale, which is considered the critical response variable.

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

NCT05094557

Principal SponsorHospital Universitari Vall d'Hebron Research Institute

Study ContactDimitra Anastasiadou, PhD

Last updated: January 28, 2026

Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

96 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.

Conditions

Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 18 to 65 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Body WeightNutrition DisordersNutritional and Metabolic DiseasesObesityObesity, MorbidSigns and SymptomsPathological Conditions, Signs and SymptomsOvernutritionOverweight

Criteria

6 inclusion criteria required to participate

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).

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6 exclusion criteria prevent from participating

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.

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Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.

Treatment Groups

Study Objectives

3 intervention groups are designated in this study

This study does not include a placebo group

Treatment Groups

Group I

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.

Group II

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.

Group III

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.

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Recruiting

Vall d'Hebron University Hospital, Psychiatry Department; Vall d'Hebron Institute of Research

Barcelona, SpainOpen Vall d'Hebron University Hospital, Psychiatry Department; Vall d'Hebron Institute of Research in Google Maps

SuspendedOne Study Center