"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]
NCT ID: NCT07205029
Last Updated: 2025-10-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
133 participants
INTERVENTIONAL
2022-01-15
2022-08-30
Brief Summary
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* 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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Control group
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: Nutritional intervention
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).
Experimental group
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: Nutritional and Virtual reality intervention
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).
Interventions
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Experimental: Nutritional and Virtual reality intervention
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 intervention
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).
Eligibility Criteria
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Inclusion Criteria
* the ability to read and write fluently;
* Spanish as a mother tongue.
Exclusion Criteria
* 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.
18 Years
65 Years
ALL
No
Sponsors
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Instituto de Investigación Sanitaria y Biomédica de Alicante
NETWORK
Jorge Azorin Lopez
OTHER
Responsible Party
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Jorge Azorin Lopez
Principal Investigator. Full professor at the University of Alicante.
Principal Investigators
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Jorge Azorín López, Computer engineering
Role: PRINCIPAL_INVESTIGATOR
University of Alicante
Locations
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University of Alicante
Alicante, Alicante, Spain
Countries
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References
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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.
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.
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.
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.
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.
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.
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
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Document Type: Informed Consent Form
Related Links
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TECH4DIET webpage
Other Identifiers
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PID2023-149562OB-I00
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
UA-2021-11-18
Identifier Type: -
Identifier Source: org_study_id
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