Body ImageTech4D-PredictNCT07205029

"Predictive Models of the Morphological Evolution of the Human Body to Improve Adherence and Motivation in Dietetic-nutritional Treatments of Overweight and Obesity" [Modelos Predictivos de Evolución Corporal Para Mejorar la Adherencia en Tratamientos de Sobrepeso y Obesidad]

A study testing Experimental: Nutritional and Virtual reality intervention in people with Body Image and Executive Function (Cognition), run by Jorge Azorin Lopez at 1 site in Spain.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

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… Read more about this study

Who is it for?: Ages 18 to 65 years
Conditions the study is for: Body Image, Executive Function (Cognition), Obesity &Amp;Amp;Amp; Overweight
What is being tested?: Experimental: Nutritional and Virtual reality intervention
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 133 participants
Where: 1 siteSpain
Study dates: 15 Jan 2022to 30 Aug 2022
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 65 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

a BMI greater than 24.9 kg/m2 [overweight (25 ≥ BMI < 30) and obese (BMI ≥ 30)] according to the BMI classification of the WHO;
the ability to read and write fluently;
Spanish as a mother tongue.

Who cannot join

currently being or having been in dietetic-nutritional treatment supervised by a nutritionist in the last year;
the presence of an endocrine-metabolic disorder (including thyroid, pituitary gland, and adrenal gland problems and metabolic syndrome);
the presence of a previous history of neurological disease (e.g., stroke or Parkinson's disease) or a history of head trauma;
the presence of a history of severe psychopathology according to the diagnostic criteria of the DSM-IV-TR;
currently receiving psychiatric treatment.

Trial locations and contacts

1 site in 1 country.

Spain1 site

University of Alicante
Alicante, Alicante, 03690

Other trials in Spain

About this study

Official title: "Predictive Models of Human Body Morphological Evolution to Improve Adherence and Motivation in Dietary-Nutritional Treatments for Overweight and Obesity" [Modelos Predictivos de la Evolución Morfológica Del Cuerpo Humano Para Mejorar la Adherencia y Motivación en Tratamientos Dietético-nutricionales Del Sobrepeso y la Obesidad].

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.

Conditions: Body Image, Executive Function (Cognition), Obesity &Amp;Amp;Amp; Overweight
Being tested: Experimental: Nutritional and Virtual reality intervention, Control: Nutritional intervention
Keywords: obesity treatment, Virtual Reality intervention, Executive function in overweight and obese individuals, Body image perception, 4D model
Medical subject headings: Obesity, Overweight

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Experimental: Nutritional and Virtual reality interventionCombination 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).
Control: Nutritional interventionCombination 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).

Study groups in NCT07205029
Study group	Role	What they receive
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). Receives: Combination Product: Control: Nutritional intervention
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). Receives: Combination Product: Experimental: Nutritional and Virtual reality intervention

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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).
Measured: 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)
Measured: 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 (%)
Measured: 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 (%).
Measured: 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 (%).
Measured: 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 (%).
Measured: 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 (%).
Measured: 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 (%).
Measured: 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 (%).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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 (%).
Measured: 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
Measured: 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
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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).
Measured: 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.
Measured: From enrollment to the end of treatment at 6 months.

Secondary outcomes (11)

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.
Measured: 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).
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: From enrollment to the end of treatment at 6 months.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

15 Jan 202230 Aug 2022

First posted3 Oct 2025
Study start15 Jan 2022
Primary completion28 Feb 2022
Study completion30 Aug 2022

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (12)Papers the sponsor has linked to this study.
Other trials for Body ImageStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Participant
Enrolment: 133 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT07205029
Sponsor's protocol ID: UA-2021-11-18
Other IDs: PID2023-149562OB-I00
Acronym: Tech4D-Predict
Status last verified: Sep 2025
First submitted: 18 Sep 2025
Last updated: 3 Oct 2025
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No: 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.

Publications

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.
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.
PubMed 15162136
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.
PubMed 12900694
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.
PubMed 18816004
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.
PubMed 11011872
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.
PubMed 34201258
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.
PubMed 34222306
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.
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
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
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
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.
PubMed 41862984

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 3 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: "Predictive Models of Human Body Morphological Evolution to Improve Adherence and Motivation in Dietary-Nutritional Treatments for Overweight and Obesity" [Modelos Predictivos de la Evolución Morfológica Del Cuerpo Humano Para Mejorar la Adherencia y Motivación en Tratamientos Dietético-nutricionales Del Sobrepeso y la Obesidad].
ClinicalTrials.gov ID: NCT07205029
Acronym / sponsor ID: Tech4D-Predict / UA-2021-11-18
Conditions: Body Image, Executive Function (Cognition), Obesity &Amp;Amp;Amp; Overweight
Keywords: obesity treatment, Virtual Reality intervention, Executive function in overweight and obese individuals, Body image perception, 4D model
Study type: Interventional
Recruitment status: Completed
Enrolment: 133 participants (actual)
Lead sponsor: Jorge Azorin LopezUniversity, hospital or other
Collaborators: Instituto de Investigación Sanitaria y Biomédica de Alicante
Study start: 15 Jan 2022 (actual)
Primary completion: 28 Feb 2022 (actual)
Study completion: 30 Aug 2022 (actual)
First posted: 3 Oct 2025 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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 design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (participant)
Number of arms: 2

Arm	Type	Receives
Control group	Active comparator	Combination Product: Control: Nutritional interventionOver 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).
Experimental group	Experimental	Combination Product: Experimental: Nutritional and Virtual reality interventionOver 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).

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

a BMI greater than 24.9 kg/m2 [overweight (25 ≥ BMI < 30) and obese (BMI ≥ 30)] according to the BMI classification of the WHO;
the ability to read and write fluently;
Spanish as a mother tongue.

Key exclusion criteria (5 listed)

currently being or having been in dietetic-nutritional treatment supervised by a nutritionist in the last year;
the presence of an endocrine-metabolic disorder (including thyroid, pituitary gland, and adrenal gland problems and metabolic syndrome);
the presence of a previous history of neurological disease (e.g., stroke or Parkinson's disease) or a history of head trauma;
the presence of a history of severe psychopathology according to the diagnostic criteria of the DSM-IV-TR;
currently receiving psychiatric treatment.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Experimental: Nutritional and Virtual reality interventionOver 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).	Combination product	Experimental group
Control: Nutritional interventionOver 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).	Combination product	Control group

Primary outcome

Body Mass Index (BMI)
Time frame: From enrollment to the end of treatment at 6 months
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.
Weight
Time frame: From enrollment to the end of treatment at 6 months.
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).
Height
Time frame: From enrollment to the end of treatment at 6 months
Height measured in standing position without shoes using a SECA 213 portable stadiometer (SECA, Hamburg, Germany). Unit of Measure: meters (m)
Body fat
Time frame: From enrollment to the end of treatment at 6 months
Body fat percentage measured using a TANITA MC-780MA P digital scale (TANITA Corporation, Arlington Heights, IL, USA). Unit of Measure: percent (%)
Visceral fat
Time frame: From enrollment to the end of treatment at 6 months
Visceral fat percentage measured using the TANITA MC-780MA P digital scale. Unit of Measure: percent (%).
Trunk fat
Time frame: From enrollment to the end of treatment at 6 months
Fat percentage in the trunk region measured using the TANITA MC-780MA P digital scale. Unit of Measure: percent (%).
Fat in Right Arm
Time frame: From enrollment to the end of treatment at 6 months
Fat percentage in the right arm measured using the TANITA MC-780MA P digital scale. Unit of Measure: percent (%).
Fat in Left Arm
Time frame: From enrollment to the end of treatment at 6 months
Fat percentage in the left arm measured using the TANITA MC-780MA P digital scale. Unit of Measure: percent (%).
Fat in Right Leg
Time frame: From enrollment to the end of treatment at 6 months
Fat percentage in the right leg measured using the TANITA MC-780MA P digital scale. Unit of Measure: percent (%).
Fat in Left Leg
Time frame: From enrollment to the end of treatment at 6 months
Fat percentage in the left leg measured using the TANITA MC-780MA P digital scale. Unit of Measure: percent (%).
Waist Circumference
Time frame: From enrollment to the end of treatment at 6 months
Waist measured with a flexible measuring tape with 0.1 cm precision. Measurements performed twice. Unit of Measure: centimeters (cm).
Hip Circumference
Time frame: From enrollment to the end of treatment at 6 months
Hip measured with a flexible measuring tape with 0.1 cm precision. Measurements performed twice. Unit of Measure: centimeters (cm).
Waist-Hip Ratio (WHR)
Time frame: From enrollment to the end of treatment at 6 months
Calculated as the ratio of waist to hip circumference. Unit of Measure: ratio (unitless).
Wrist Circumference
Time frame: From enrollment to the end of treatment at 6 months
Measured using a flexible measuring tape with 0.1 cm precision. Measurements performed twice. Unit of Measure: centimeters (cm).
Muscle Mass
Time frame: From enrollment to the end of treatment at 6 months
Total body muscle mass measured using the TANITA MC-780MA P digital scale. Unit of Measure: kilograms (kg).
Total Body Water
Time frame: From enrollment to the end of treatment at 6 months
Total body water percentage measured using the TANITA MC-780MA P digital scale. Unit of Measure: percent (%).
Glucose Level
Time frame: From enrollment to the end of treatment at 6 months.
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
Total Cholesterol
Time frame: From enrollment to the end of treatment at 6 months.
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
Triglycerides
Time frame: From enrollment to the end of treatment at 6 months.
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
Systolic Blood Pressure
Time frame: From enrollment to the end of treatment at 6 months.
Measured using the M7 Intelli IT sphygmomanometer (OMRON, M7, Corp., Kyoto, Japan). Unit of Measure: mmHg.
Diastolic Blood Pressure
Time frame: From enrollment to the end of treatment at 6 months.
Measured using the M7 Intelli IT sphygmomanometer (OMRON, M7, Corp., Kyoto, Japan). Unit of Measure: mmHg.
Interleukin 6 (IL-6)
Time frame: From enrollment to the end of treatment at 6 months.
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.
Tumor Necrosis Factor Alpha (TNF-α)
Time frame: From enrollment to the end of treatment at 6 months.
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.
C-Reactive Protein (CRP)
Time frame: From enrollment to the end of treatment at 6 months.
Measured in serum samples via immunonephelometry using a Dade Behring BNII nephelometer. Unit of Measure: mg/L.
Cognition: executive function
Time frame: From enrollment to the end of treatment at 6 months.
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).
Body Image perception
Time frame: From enrollment to the end of treatment at 6 months.
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).
3D and 4D Imaging
Time frame: From enrollment to the end of treatment at 6 months.
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.

11 secondary outcomes

Nutritional and Lifestyle measures: Physical Activity
Time frame: From enrollment to the end of treatment at 6 months.
Nutritional and Lifestyle measures: Adherence to the Mediterranean Diet
Time frame: From enrollment to the end of treatment at 6 months.
Nutritional and Lifestyle measures: Food Frequency Questionnaire
Time frame: From enrollment to the end of treatment at 6 months.
Nutritional and Lifestyle measures: 24-Hour Dietary Recall
Time frame: From enrollment to the end of treatment at 6 months.
Psychological measures: Premorbid Intelligence
Time frame: From enrollment to the end of treatment at 6 months.
Psychological Measures: Emotional Eating
Time frame: From enrollment to the end of treatment at 6 months.
Psychological Measures: Prefrontal Symptoms
Time frame: From enrollment to the end of treatment at 6 months.
Psychological Measures: Impulsivity
Time frame: From enrollment to the end of treatment at 6 months.
Psychological Measures: Health-Related Quality of Life
Time frame: From enrollment to the end of treatment at 6 months.
Psychological Measures: Depression
Time frame: From enrollment to the end of treatment at 6 months.
Psychological Measures: Life Satisfaction
Time frame: From enrollment to the end of treatment at 6 months.

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 3 Oct 2025.
BackgroundGonzález, 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.
Background: PubMed 15162136Martinez-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.
Background: PubMed 12900694Craig 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.
Background: PubMed 18816004Botella 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.
Background: PubMed 11011872Pons 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.
Background: PubMed 34201258Rumbo-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.
Results publication: PubMed 34222306Zaragoza-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.
Results publicationN. 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.
Results publicationMauricio-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
Results publicationL. 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
Results publicationAzorin-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
Derived from this study: PubMed 41862984Berbegal-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.
TECH4DIET webpageLink provided by the sponsor.
Individual participant dataSharing planned: No. 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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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Jorge Azorín López, Computer engineering principal investigator

University of Alicante

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Experimental: Nutritional and Virtual reality intervention in people with Body Image and Executive Function (Cognition), run by Jorge Azorin Lopez at 1 site in Spain.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 3 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Body Mass Index (BMI) (time frame: From enrollment to the end of treatment at 6 months). The study lists 27 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07205029, which also lists 12 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Oct 2025.