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Completed

NCT Number: 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]

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.

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Key information

Conditions

Body Image Body Weight Executive Function (Cognition) Nutrition Disorders Nutritional and Metabolic Diseases Obesity Obesity &Amp;Amp;Amp; Overweight Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Alicante

Alicante, 03690, Spain

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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).

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).

Primary outcomes

  1. 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.

  2. 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).

  3. 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)

  4. 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 (%)

  5. 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 (%).

  6. 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 (%).

  7. 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 (%).

  8. 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 (%).

  9. 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 (%).

  10. 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 (%).

  11. 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).

  12. 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).

  13. 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).

  14. 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).

  15. 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).

  16. 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 (%).

  17. 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

  18. 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

  19. 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

  20. 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.

  21. 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.

  22. 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.

  23. 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.

  24. 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.

  25. 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).

  26. 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).

  27. 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.

Secondary outcomes

  1. Nutritional and Lifestyle measures: Physical Activity

    Time frame: From enrollment to the end of treatment at 6 months.

    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.

  2. Nutritional and Lifestyle measures: Adherence to the Mediterranean Diet

    Time frame: From enrollment to the end of treatment at 6 months.

    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).

  3. Nutritional and Lifestyle measures: Food Frequency Questionnaire

    Time frame: From enrollment to the end of treatment at 6 months.

    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).

  4. Nutritional and Lifestyle measures: 24-Hour Dietary Recall

    Time frame: From enrollment to the end of treatment at 6 months.

    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.

  5. Psychological measures: Premorbid Intelligence

    Time frame: From enrollment to the end of treatment at 6 months.

    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.

  6. Psychological Measures: Emotional Eating

    Time frame: From enrollment to the end of treatment at 6 months.

    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).

  7. Psychological Measures: Prefrontal Symptoms

    Time frame: From enrollment to the end of treatment at 6 months.

    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).

  8. Psychological Measures: Impulsivity

    Time frame: From enrollment to the end of treatment at 6 months.

    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).

  9. Psychological Measures: Health-Related Quality of Life

    Time frame: From enrollment to the end of treatment at 6 months.

    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).

  10. Psychological Measures: Depression

    Time frame: From enrollment to the end of treatment at 6 months.

    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).

  11. Psychological Measures: Life Satisfaction

    Time frame: From enrollment to the end of treatment at 6 months.

    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).

Sponsors and collaborators

Lead sponsor

Jorge Azorin Lopez

Other

Collaborators

  • Instituto de Investigación Sanitaria y Biomédica de Alicante

Registry information

Official study 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].

Acronym: Tech4D-Predict

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Oct 3, 2025
Registry last updated
Oct 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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