NCT07205029

"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]

"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].

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 133 (actual)
• Sponsor: Jorge Azorin Lopez · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
COMBINATION_PRODUCT	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).
COMBINATION_PRODUCT	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).

Timeline

• Start date: 2022-01-15
• Primary completion: 2022-02-28
• Completion: 2022-08-30
• First posted: 2025-10-03
• Last updated: 2025-10-03

Locations

1 site across 1 country: Spain