Clinical trial NCT05094557: Clinical Efficacy of a Virtual Reality Tool for the Treatment of Obesity
Official title: Clinical Efficacy of a Virtual Reality Tool for the Treatment of Obesity (SOCRATES)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Obesity, Morbid
Keywords: Virtual Reality
obesity
Motivational Interviewing
embodiment
psychological treatment
Lead sponsor: Hospital Universitari Vall d'Hebron Research Institute
Sponsor class: OTHER
Collaborators: name: European Commission
First posted: 2021-10-26
Enrollment: 96
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility criteria: 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.

Primary outcomes:
measure: Readiness to change I
timeFrame: 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
measure: Readiness to change II
timeFrame: Baseline (week 0); Post-Intervention (week 6)- Baseline; 1-week follow-up (week 7)- Baseline; 4-week follow-up (week 10)- Baseline
Secondary outcomes:
measure: Eating habits I
timeFrame: Baseline (week 0); Post-Intervention (week 6)- Baseline; 1-week follow-up (week 7)- Baseline; 4-week follow-up (week 10)- Baseline
measure: Eating habits II
timeFrame: Baseline (week 0); Post-Intervention (week 6)- Baseline; 1-week follow-up (week 7)- Baseline; 4-week follow-up (week 10)- Baseline
measure: Psychological well-being I
timeFrame: Baseline (week 0); Post-Intervention (week 6)- Baseline; 1-week follow-up (week 7)- Baseline; 4-week follow-up (week 10)- Baseline
measure: Psychological well-being II
timeFrame: Baseline (week 0); Post-Intervention (week 6)- Baseline; 1-week follow-up (week 7)- Baseline; 4-week follow-up (week 10)- Baseline
measure: Psychological well-being III
timeFrame: Baseline (week 0); Post-Intervention (week 6)- Baseline; 1-week follow-up (week 7)- Baseline; 4-week follow-up (week 10)- Baseline
measure: Psychological well-being IV
timeFrame: Baseline (week 0); Post-Intervention (week 6)- Baseline; 1-week follow-up (week 7)- Baseline; 4-week follow-up (week 10)- Baseline
measure: Body Mass Index
timeFrame: Baseline (week 0); Post-Intervention (week 6)- Baseline; 1-week follow-up (week 7)- Baseline; 4-week follow-up (week 10)- Baseline
measure: Cognitive Reserve Questionnaire
timeFrame: Baseline (week 0)
Other outcomes:
measure: Adherence and satisfaction with the VR platform I
timeFrame: Post-Experiment1 (week 3); Post-Experiment2 (week 4)- Post-Experiment1; Post-Experiment3 (week 5)- Post-Experiment1; Post-Intervention (week 6)- Post-Experiment1
measure: Adherence and satisfaction with the VR platform II
timeFrame: Post-Experiment1 (week 3); Post-Experiment2 (week 4)- Post-Experiment1; Post-Experiment3 (week 5)- Post-Experiment1; Post-Intervention (week 6)- Post-Experiment1
measure: Adherence and satisfaction with the VR platform III
timeFrame: Post-Experiment1 (week 3); Post-Experiment2 (week 4); Post-Experiment3 (week 5); Post-Intervention (week 6)
Locations:
city: Barcelona
country: Spain
facility: Vall d'Hebron University Hospital, Psychiatry Department; Vall d'Hebron Institute of Research
Study officials:
affiliation: Vall d'Hebron University Hospital
name: Pilar Lusilla-Palacios, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Anastasiadou 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.