The objective of this clinical trial is to evaluate the effect of a personalized intervention based on the benefits of 4D body modeling and virtual reality techniques, combined with a dietary-nutritional treatment focused on the Mediterranean Diet, as a tool to improve motivation for change, adherence to treatment and health parameters in patients with overweight and obesity. The main research questions to be addressed are: * How can a 4D computer vision model combined with virtual reality improve clinical diagnoses, the analysis of morphological changes in the human body over time, and adherence to dietary-nutritional treatment? * Does adherence to an intensive multifactorial dietary-nutritional treatment based on the Mediterranean Diet (MD), supported by 4D immersive virtual reality technology, lead to improvements in cognitive functioning? * What impact does a nutritional intervention program based on the Mediterranean Diet and the use of virtual reality have on body image perception? * Can an intensive intervention based on the Mediterranean Diet and 4D virtual reality technology improve overall health? Researchers will compare the control group (which will receive nutritional recommendations based on the Mediterranean Diet) with the experimental group (which will receive nutritional recommendations based on the Mediterranean Diet and visualize their morphological changes through VR) to determine whether a personalized intervention based on the benefits of 4D modeling and virtual reality, combined with a Mediterranean Diet-focused treatment, is effective in addressing overweight and obesity. Participants are expected to: * Follow the dietary-nutritional recommendations throughout the 6-month intervention. * Visit the clinic once a month for follow-up. * Complete all clinical and psychological assessments.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
133
Over a 6-month period, the experimental group received nutritional recommendations based on the Mediterranean Diet from the nutritionist. In each session, the participant went through the 4D body modelling machine, which captures the morphological changes of each participant over time. The experimental group observed the changes in their bodies through immersive virtual reality goggles. After visualising their bodies, all participants in the experimental group completed a questionnaire designed to assess their perception of body image. Personal and sociodemographic data, clinical information, general health status, anthropometric, nutritional, and lifestyle data, as well as psychological and neuropsychological variables, were collected at two time points: at the beginning (pre-test measures) and at the end of the intervention (post-test measures).
Over a 6-month period, the control group received nutritional recommendations based on the Mediterranean Diet from the nutritionist. In each session, the participant went through the 4D modelling machine, which captures the morphological changes of each individual over time. The control group did not visualise these morphological changes through the virtual reality goggles. Personal and sociodemographic data, clinical information, general health status, anthropometric, nutritional, and lifestyle data, as well as psychological and neuropsychological variables, were collected at two time points: at the beginning (pre-test measures) and at the end of the intervention (post-test measures).
University of Alicante
Alicante, Alicante, Spain
Body Mass Index (BMI)
BMI was calculated as weight (kg) divided by height squared (m²). According to the WHO classification, overweight will be defined as a BMI ≥ 25.0 kg/m² and obesity as a BMI ≥ 30.0 kg/m².
Time frame: From enrollment to the end of treatment at 6 months
Weight
Body weight (kg) measured using a calibrated digital scale, a TANITA MC-780MA P digital scale (TANITA Corporation, Arlington Heights, IL, USA). Unit of Measure: kilograms (kg).
Time frame: From enrollment to the end of treatment at 6 months.
Height
Height measured in standing position without shoes using a SECA 213 portable stadiometer (SECA, Hamburg, Germany). Unit of Measure: meters (m)
Time frame: From enrollment to the end of treatment at 6 months
Body fat
Body fat percentage measured using a TANITA MC-780MA P digital scale (TANITA Corporation, Arlington Heights, IL, USA). Unit of Measure: percent (%)
Time frame: From enrollment to the end of treatment at 6 months
Visceral fat
Visceral fat percentage measured using the TANITA MC-780MA P digital scale. Unit of Measure: percent (%).
Time frame: From enrollment to the end of treatment at 6 months
Trunk fat
Fat percentage in the trunk region measured using the TANITA MC-780MA P digital scale. Unit of Measure: percent (%).
Time frame: From enrollment to the end of treatment at 6 months
Fat in Right Arm
Fat percentage in the right arm measured using the TANITA MC-780MA P digital scale. Unit of Measure: percent (%).
Time frame: From enrollment to the end of treatment at 6 months
Fat in Left Arm
Fat percentage in the left arm measured using the TANITA MC-780MA P digital scale. Unit of Measure: percent (%).
Time frame: From enrollment to the end of treatment at 6 months
Fat in Right Leg
Fat percentage in the right leg measured using the TANITA MC-780MA P digital scale. Unit of Measure: percent (%).
Time frame: From enrollment to the end of treatment at 6 months
Fat in Left Leg
Fat percentage in the left leg measured using the TANITA MC-780MA P digital scale. Unit of Measure: percent (%).
Time frame: From enrollment to the end of treatment at 6 months
Waist Circumference
Waist measured with a flexible measuring tape with 0.1 cm precision. Measurements performed twice. Unit of Measure: centimeters (cm).
Time frame: From enrollment to the end of treatment at 6 months
Hip Circumference
Hip measured with a flexible measuring tape with 0.1 cm precision. Measurements performed twice. Unit of Measure: centimeters (cm).
Time frame: From enrollment to the end of treatment at 6 months
Waist-Hip Ratio (WHR)
Calculated as the ratio of waist to hip circumference. Unit of Measure: ratio (unitless).
Time frame: From enrollment to the end of treatment at 6 months
Wrist Circumference
Measured using a flexible measuring tape with 0.1 cm precision. Measurements performed twice. Unit of Measure: centimeters (cm).
Time frame: From enrollment to the end of treatment at 6 months
Muscle Mass
Total body muscle mass measured using the TANITA MC-780MA P digital scale. Unit of Measure: kilograms (kg).
Time frame: From enrollment to the end of treatment at 6 months
Total Body Water
Total body water percentage measured using the TANITA MC-780MA P digital scale. Unit of Measure: percent (%).
Time frame: From enrollment to the end of treatment at 6 months
Glucose Level
Capillary glucose measured using the Accutrend® Plus device (Roche Diagnostics GmbH, Mannheim, Germany) from 15-40 μL blood collected via finger prick (Accu-Chek® Softclix® Pro lancing device). Unit of Measure: mg/dL
Time frame: From enrollment to the end of treatment at 6 months.
Total Cholesterol
Capillary total cholesterol measured using the Accutrend® Plus device (Roche Diagnostics GmbH, Mannheim, Germany) from 15-40 μL blood collected via finger prick (Accu-Chek® Softclix® Pro lancing device). Unit of Measure: mg/dL
Time frame: From enrollment to the end of treatment at 6 months.
Triglycerides
Capillary triglycerides measured using the Accutrend® Plus device (Roche Diagnostics GmbH, Mannheim, Germany) from 15-40 μL blood collected via finger prick (Accu-Chek® Softclix® Pro lancing device). Unit of Measure: mg/dL
Time frame: From enrollment to the end of treatment at 6 months.
Systolic Blood Pressure
Measured using the M7 Intelli IT sphygmomanometer (OMRON, M7, Corp., Kyoto, Japan). Unit of Measure: mmHg.
Time frame: From enrollment to the end of treatment at 6 months.
Diastolic Blood Pressure
Measured using the M7 Intelli IT sphygmomanometer (OMRON, M7, Corp., Kyoto, Japan). Unit of Measure: mmHg.
Time frame: From enrollment to the end of treatment at 6 months.
Interleukin 6 (IL-6)
IL-6 measured from peripheral blood obtained via venipuncture using a bead-based multiplex assay (xMAP) with Luminex 200 flow cytometer. Unit of Measure: pg/mL.
Time frame: From enrollment to the end of treatment at 6 months.
Tumor Necrosis Factor Alpha (TNF-α)
TNF-α measured from peripheral blood obtained via venipuncture using a bead-based multiplex assay (xMAP) with Luminex 200 flow cytometer. Unit of Measure: pg/mL.
Time frame: From enrollment to the end of treatment at 6 months.
C-Reactive Protein (CRP)
Measured in serum samples via immunonephelometry using a Dade Behring BNII nephelometer. Unit of Measure: mg/L.
Time frame: From enrollment to the end of treatment at 6 months.
Cognition: executive function
Executive function assessed using the computerized General Cognitive Assessment Battery (CAB) from CogniFit. The battery includes neuropsychological tests evaluating cognitive flexibility, divided attention, planning, visual and auditory perception, spatial perception, contextual memory, short-term visual and auditory memory, non-verbal memory, working memory, processing speed, naming, estimation, monitoring, response time, visual scanning, recognition, hand-eye coordination, focused attention, and inhibition. Test duration ranges from 25 to 45 minutes. Scores range from 0 to 800, with higher scores indicating better cognitive performance. Unit of Measure: CAB score (0-800).
Time frame: From enrollment to the end of treatment at 6 months.
Body Image perception
Body image perception assessed using the Spanish short version of the Multidimensional Body-Self Relations Questionnaire (MBSRQ). The questionnaire contains 45 items divided into two parts: General body image perception: scored on a Likert scale from 1 (Totally disagree) to 5 (Totally agree); and Satisfaction with specific body areas: scored on a Likert scale from 1 (Very dissatisfied) to 5 (Very satisfied). Higher scores indicate a more positive body image perception. Unit of Measure: points (Minimum Value: 45 - Maximum Value: 225).
Time frame: From enrollment to the end of treatment at 6 months.
3D and 4D Imaging
Morphological 4D images of participants were captured during each session using a 3D imaging system equipped with RGB-D devices. The 4D model represents morphological changes over time. Using cost-effective, wide-spectrum 3D acquisition technologies (RGB-D sensors), a 4D model was constructed as the core of a system for visualizing the human body over time. This model allows for precise and realistic visualization of body changes. Throughout the intervention, 3D morphological images of the participants were obtained, allowing them to observe their physical evolution through immersive Virtual Reality (VR)-a feature available only to the experimental group.
Time frame: From enrollment to the end of treatment at 6 months.
Nutritional and Lifestyle measures: Physical Activity
Physical activity over the previous 7 days assessed using the International Physical Activity Questionnaire (IPAQ), Spanish Version, including 7 questions on frequency, duration, and intensity (vigorous and moderate), walking, and time spent sitting on a typical weekday. Higher scores indicate higher levels of physical activity. Unit of Measure: MET-minutes/week.
Time frame: From enrollment to the end of treatment at 6 months.
Nutritional and Lifestyle measures: Adherence to the Mediterranean Diet
Assessed using the 14-item PREDIMED Mediterranean Diet Adherence Questionnaire. Each item scores 0 or 1. Total scores range from 0 to 14, with scores ≥ 8 indicating good adherence and \< 8 indicating low adherence to the Mediterranean Diet. Higher scores indicate better adherence. Unit of Measure: points (Minimum Value: 0 - Maximum Value: 14).
Time frame: From enrollment to the end of treatment at 6 months.
Nutritional and Lifestyle measures: Food Frequency Questionnaire
Dietary habits assessed using a 118-item Food Frequency Questionnaire adapted for the Spanish population. Scores range from 0 (never or \<1/month) to 8 (+6 times per day). Higher scores indicate higher frequency of consumption of the specified food items. Unit of Measure: frequency (Minimum Value: 0 - Maximum Value: 8).
Time frame: From enrollment to the end of treatment at 6 months.
Nutritional and Lifestyle measures: 24-Hour Dietary Recall
Dietary intake assessed via three 24-hour dietary recalls (two weekdays and one weekend/holiday) to estimate nutrient and caloric intake. Higher values indicate higher intake. Unit of Measure: kilocalories (kcal) and grams of macronutrients per day.
Time frame: From enrollment to the end of treatment at 6 months.
Psychological measures: Premorbid Intelligence
Premorbid intelligence estimated based on the correct accentuation of 30 words, assessed using the Word Accentuation Test (TAP). The number of correct responses corresponds to an estimated IQ score based on the WAIS-IV scale. Higher scores indicate higher estimated premorbid intelligence. Unit of Measure: IQ points.
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Time frame: From enrollment to the end of treatment at 6 months.
Psychological Measures: Emotional Eating
Assesses the influence of emotions on food choices through the Emotional Eater Questionnaire (CCE). 10 items scored on a Likert scale from 0 (Never) to 3 (Always). Higher scores indicate greater emotional influence on eating habits. Unit of Measure: points (Minimum Value: 0 - Maximum Value: 30).
Time frame: From enrollment to the end of treatment at 6 months.
Psychological Measures: Prefrontal Symptoms
Self-reported measure of cognitive, emotional, and behavioral disturbances in daily life, assessed using the Prefrontal Symptom Inventory, ISP-20 (Abbreviated Version). 20 items scored on a Likert scale from 0 (Never/almost never) to 4 (Always/almost always). Higher scores indicate more severe prefrontal symptoms. Unit of Measure: points (Minimum Value: 0 - Maximum Value: 80).
Time frame: From enrollment to the end of treatment at 6 months.
Psychological Measures: Impulsivity
Measures impulsivity across three subscales: cognitive (8 items), motor (10 items), and non-planning (12 items), assessed using the Barratt Impulsiveness Scale, BIS-11. Each item scored 0-4 (0=Rarely/Never, 4=Almost Always). Higher scores indicate greater impulsivity. Unit of Measure: points (Minimum Value: 0 - Maximum Value: 120).
Time frame: From enrollment to the end of treatment at 6 months.
Psychological Measures: Health-Related Quality of Life
Assesses physical and mental health-related quality of life using the Short Form-12 Health Survey (SF-12). 12 items scored from 0 (worst health) to 100 (best health). Higher scores indicate better health-related quality of life. Unit of Measure: points (Minimum Value: 0 - Maximum Value: 100).
Time frame: From enrollment to the end of treatment at 6 months.
Psychological Measures: Depression
21-item self-report questionnaire assessing depressive symptoms, measured using the Beck Depression Inventory-II (BDI-II). Items scored 0 (Not at all) to 3 (Severely). Higher scores indicate more severe depressive symptoms. Unit of Measure: points (Minimum Value: 0 - Maximum Value: 63).
Time frame: From enrollment to the end of treatment at 6 months.
Psychological Measures: Life Satisfaction
Measures global life satisfaction using the Satisfaction With Life Scale (SWLS). 5 items scored on a 7-point Likert scale (1=Completely disagree, 7=Completely agree). Higher scores indicate greater life satisfaction. Unit of Measure: points (Minimum Value: 5 - Maximum Value: 35).
Time frame: From enrollment to the end of treatment at 6 months.