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

Not Applicable

• Conditions: Obesity, Morbid

• Registration Number: NCT05094557
• Lead Sponsor: Hospital Universitari Vall d'Hebron Research Institute

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-09-27
• Study First Submitted QC: 2021-10-14
• Study First Posted: 2021-10-26
• Study Start: 2022-01-31
• Status Verified: 2022-04
• Last Update Submitted: 2022-04-29
• Last Update Posted: 2022-05-05
• Primary Completion: 2022-10
• Study Completion: 2022-10

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 96

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Readiness to change I	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	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.

Secondary Outcome Measures

Name	Time	Method
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	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.
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	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.
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	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.
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	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.
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	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.
Psychological well-being IV	Baseline (week 0); Post-Intervention (week 6)- Baseline; 1-week follow-up (week 7)- Baseline; 4-week follow-up (week 10)- Baseline	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.
Body Mass Index	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 (kg/m2)
Cognitive Reserve Questionnaire	Baseline (week 0)	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).

Trial Locations

Locations (1)

Vall d'Hebron University Hospital, Psychiatry Department; Vall d'Hebron Institute of Research; 🇪🇸 Barcelona, Spain