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| ID | Type | Description | Link |
|---|---|---|---|
| PID2023-149562OB-I00 | Other Grant/Funding Number | Ministerio de Ciencia e Innovación y Universidades. Gobierno de España (MICIU/AEI/10.13039/501100011033 y FEDER/UE). [M |
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| Name | Class |
|---|---|
| Instituto de Investigación Sanitaria y Biomédica de Alicante | NETWORK |
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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:
Participants are expected to:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control group | Active Comparator | 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). |
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| Experimental group | Experimental | 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). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Experimental: Nutritional and Virtual reality intervention | Combination Product | 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). |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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). | 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) | 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 (%) | 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 (%). | 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 (%). | From enrollment to the end of treatment at 6 months |
| Fat in Right Arm |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jorge Azorín López, Computer engineering | University of Alicante | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alicante | Alicante | Alicante | 03690 | Spain |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Background | González, Mariela. (2018). Validación del Cuestionario de Comedor Emocional (CCE) en Chile. Gen, 72(1), 21-24. Recuperado en 21 de noviembre de 2021, de http://ve.scielo.org/scielo.php?script=sci_arttext&pid=S001635032018000100005&lng=es&tlng=es. | ||
| 15162136 | Background | Martinez-Gonzalez MA, Fernandez-Jarne E, Serrano-Martinez M, Wright M, Gomez-Gracia E. Development of a short dietary intake questionnaire for the quantitative estimation of adherence to a cardioprotective Mediterranean diet. Eur J Clin Nutr. 2004 Nov;58(11):1550-2. doi: 10.1038/sj.ejcn.1602004. | |
| 12900694 |
| Label | URL |
|---|---|
| TECH4DIET webpage | View source |
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At this time, the data cannot be shared because the patent registration process for the developed software is still ongoing. Until this stage is completed, it is not possible to consider sharing the Individual Participant Data (IPD) with other researchers. However, the project has been granted an extension and is currently in the analysis phase and in the process of creating a global database that integrates all the collected variables. Once this process is completed and the legal issues related to the patent are resolved, the data is expected to be published and made publicly available.
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Feb 1, 2024 |
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| Control: Nutritional intervention | Combination Product | 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). |
|
Fat percentage in the right arm measured using the TANITA MC-780MA P digital scale. Unit of Measure: percent (%). |
| 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 (%). | 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 (%). | 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 (%). | 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). | 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). | 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). | 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). | 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). | 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 (%). | 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 | 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 | 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 | 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. | 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. | 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. | 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. | 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. | 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). | 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). | 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. | From enrollment to the end of treatment at 6 months. |
| 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). | 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). | 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. | 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. | 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). | 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). | 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). | 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). | 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). | 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). | From enrollment to the end of treatment at 6 months. |
| Background |
| Craig CL, Marshall AL, Sjostrom M, Bauman AE, Booth ML, Ainsworth BE, Pratt M, Ekelund U, Yngve A, Sallis JF, Oja P. International physical activity questionnaire: 12-country reliability and validity. Med Sci Sports Exerc. 2003 Aug;35(8):1381-95. doi: 10.1249/01.MSS.0000078924.61453.FB. |
| 18816004 | Background | Botella L, Corbella S, Belles L, Pacheco M, Maria Gomez A, Herrero O, Ribas E, Pedro N. Predictors of therapeutic outcome and process. Psychother Res. 2008 Sep;18(5):535-42. doi: 10.1080/10503300801982773. |
| 11011872 | Background | Pons D, Atienza FL, Balaguer I, Garcia-Merita ML. Satisfaction with life scale: analysis of factorial invariance for adolescents and elderly persons. Percept Mot Skills. 2000 Aug;91(1):62-8. doi: 10.2466/pms.2000.91.1.62. |
| 34201258 | Background | Rumbo-Rodriguez L, Sanchez-SanSegundo M, Ferrer-Cascales R, Garcia-D'Urso N, Hurtado-Sanchez JA, Zaragoza-Marti A. Comparison of Body Scanner and Manual Anthropometric Measurements of Body Shape: A Systematic Review. Int J Environ Res Public Health. 2021 Jun 8;18(12):6213. doi: 10.3390/ijerph18126213. |
| 34222306 | Result | Zaragoza-Marti A, Sanchez-SanSegundo M, Ferrer-Cascales R, Gabaldon-Bravo EM, Laguna-Perez A, Rumbo-Rodriguez L. Effects of the Mediterranean Lifestyle During the COVID-19 Lockdown in Spain: Preliminary Study. Front Nutr. 2021 Jun 18;8:683261. doi: 10.3389/fnut.2021.683261. eCollection 2021. |
| Result | N. García-D'urso, P. Climent-Pérez, M. Sánchez-Sansegundo, A. Zaragoza-Martí, A. Fuster-Guilló and J. Azorín-López, "A Non-Invasive Approach for Total Cholesterol Level Prediction Using Machine Learning," in IEEE Access, vol. 10, pp. 58566-58577, 2022, https://doi.org/10.1109/ACCESS.2022.3178419. |
| Result | Mauricio-Andres Zamora-Hernandez, Jose Andrez Chaves Ceciliano, Alonso Villalobos Granados, John Alejandro Castro Vargas, Jose Garcia-Rodriguez, Jorge Azorin-Lopez, "MDL+ a manufacturing description language to describe and control assembling tasks in industry 4.0", Logic Journal of the IGPL, 2022; jzac032, https://doi.org/10.1093/jigpal/jzac032 |
| Result | L. F. Borja-Borja, J. Azorín-López, M. Saval-Calvo, A. Fuster-Guilló and M. Sebban, "Architecture for Automatic Recognition of Group Activities Using Local Motions and Context," in IEEE Access, vol. 10, pp. 79874-79889, 2022, https://doi.org/10.1109/ACCESS.2022.3195035 |
| Result | Azorin-Lopez, Jorge, Fuster-Guilló, Andrés, Saval-Calvo, Marcelo, Villena Martínez, Víctor, Castillo Zaragoza, Juan Miguel, Garcia-d'Urso, Nahuel, Manchón Martínez, Cayetano, Ferrer-Cascales, Rosario, Zaragoza Martí, Ana, Sebban, Marc URI: http://hdl.handle.net/10045/119300 |
| 41862984 | Derived | Berbegal-Bernabeu M, Garcia-D'Urso N, Sanchez-Sansegundo M, Vives-Cases C, Tome-Fernandez M, Zaragoza-Marti A. Usefulness of a virtual reality programme for body self-image in obese and overweight patients: a focus on gender differences - a randomised trial. Arch Public Health. 2026 Mar 21;84(1):97. doi: 10.1186/s13690-026-01893-4. |
| Sep 18, 2025 |
| Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Dec 10, 2021 | Jul 24, 2025 | ICF_001.pdf |
| ID | Term |
|---|---|
| D009765 | Obesity |
| D050177 | Overweight |
| ID | Term |
|---|---|
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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