"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] (Tech4D-Predict)

Jorge Azorin Lopez

Status: Completed

Conditions: Executive Function (Cognition); Obesity &Amp;Amp;Amp; Overweight; Body Image

Treatments: Combination Product: Experimental: Nutritional and Virtual reality intervention; Combination Product: Control: Nutritional intervention

Study type: Interventional

Funder types: Other; NETWORK

Identifiers

NCT07205029

UA-2021-11-18

PID2023-149562OB-I00 (Other Grant/Funding Number)

Details and patient eligibility

About

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.

Enrollment: 133 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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.

Exclusion criteria

• 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 design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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133 participants in 2 patient groups

Control group

Active Comparator group

Description:

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).

Treatment:

Combination Product: Control: Nutritional intervention

Experimental group

Experimental group

Description:

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).

Treatment:

Combination Product: Experimental: Nutritional and Virtual reality intervention