"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]

NCT07205029 | Completed

• 2 other identifiers: UA-2021-11-18PID2023-149562OB-I00
• Study Type: interventional
• Target: 133
• Locations: 1 country
• Sites: 1

Brief 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 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.

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

Outcome Measures

Primary Outcomes (27)

• 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

  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.

Secondary Outcomes (11)

• Nutritional and Lifestyle measures: Physical Activity

  From enrollment to the end of treatment at 6 months.

• Nutritional and Lifestyle measures: Adherence to the Mediterranean Diet

  From enrollment to the end of treatment at 6 months.

• Nutritional and Lifestyle measures: Food Frequency Questionnaire

  From enrollment to the end of treatment at 6 months.

• Nutritional and Lifestyle measures: 24-Hour Dietary Recall

  From enrollment to the end of treatment at 6 months.

• Psychological measures: Premorbid Intelligence

  From enrollment to the end of treatment at 6 months.

Study Arms (2)

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).

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).

Combination Product: Experimental: Nutritional and Virtual reality intervention

Interventions

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).

Experimental group

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).

Control group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Jorge Azorin Lopez: lead
• Instituto de Investigación Sanitaria y Biomédica de Alicante: collaborator

Study Sites (1)

University of Alicante

Alicante, Alicante, 03690, Spain

Location

Related Publications (11)

• 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.

  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.

  PMID: 15162136 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.

  PMID: 12900694 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.

  PMID: 18816004 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.

  PMID: 11011872 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.

  PMID: 34201258 BACKGROUND

• 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.

  PMID: 34222306 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

  RESULT

Related Links

• TECH4DIET webpage

MeSH Terms

Conditions

Obesity; Overweight

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Jorge Azorín López, Computer engineering

  University of Alicante

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator. Full professor at the University of Alicante.

Study Record Dates

• First Submitted: September 18, 2025
• First Posted: October 3, 2025
• Study Start: January 15, 2022
• Primary Completion: February 28, 2022
• Study Completion: August 30, 2022
• Last Updated: October 3, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)