Clinical Efficacy of a Virtual Reality Tool for the Treatment of Obesity (SOCRATES)
试验速览
- 阶段
- 不适用
- 入组人数
- 96
- 试验地点
- 2
- 主要终点
- Readiness to change I
研究概览
简要总结
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •BMI ≥ 30 kg/m2 and ≤ 55 kg/m
- •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.
排除标准
- •Body Mass Index >
- •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.
结局指标
主要结局
Readiness to change I
时间窗: 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
时间窗: 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.
次要结局
- 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)
- 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 III(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(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(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(Baseline (week 0))