SEMEiotic Oriented Technology for Individual's CardiOmetabolic Risk Self- assessmeNt and Self-monitoring

NCT02818504 | Completed

• 1 other identifier: GA 611516
• Study Type: interventional
• Target: 78
• Locations: 2 countries
• Sites: 3

Brief Summary

Cardio-metabolic risk factors include obesity, physical inactivity, smoke, alcohol abuse, high blood lipids or sugar and arterial hypertension. Systems for self-learning and self-monitoring may help people improve and maintain a healthy lifestyle through tailored suggestions about diet, weight control, physical activity, fatigue,stress. SEMEOTICONS exploits the human face as an indicator of individual's health status and translates signs obtained from the face using contactless sensors into measures and descriptors to be automatically evaluated by a an interactive smart mirror. This "Wize Mirror" extracts descriptors from videos, images and gas concentration signals and integrates them in a virtual model used to compute and trace the evolution of an individual's wellness index. A health diary enables each individual to evaluate and personally relate his/her lifestyle to his/her well-being. Coaching messages are provided, in relation to the evolution of the wellness index and of each descriptor, to provide useful suggestions on correct lifestyle self-monitoring. The purpose of this study is assess the accuracy of the information derived from the Wize Mirror in expressing the health status of the individual. The reproducibility and repeatability study will evaluate whether measurements are stable over short time spans and whether they are influenced by meals light and temperature conditions. To verify whether the Wize Mirror is able to detect variations in physical and emotional health status with appropriate lifestyle changes, the validation study will cross-check measurements from the Wize Mirror against reference clinical tests at enrolment and after 3 months of personalized suggestions for healthy behavior. Reference tests include

• Physician visit
• Measurement of blood oxygen content and skin end products of sugar metabolism,body composition, energy expenditure, vascular function
• Laboratory profile and exhaled gas composition
• Questionnaires on quality of life and lifestyle (food, sleep, physical activity, smoking, alcohol, stress). Wize Mirror measures include
• 3D reconstruction of face images for roundness, color, stress and fatigue
• Heart and respiratory rate
• Detection of skin sugar metabolism end-products and of eye lipid deposits
• Small vessel vasodilating ability with local heating The results will allow to assess whether the Wize Mirror is easy to use and helpful for self-monitoring of cardio-metabolic risk.

Conditions

Cardiovascular Risk Factor

Keywords

obesity; dysglycemia; hypercholesterolemia; lifestyle; smoking; physical activity

Outcome Measures

Primary Outcomes (1)

• Plumpness index

  a geodetic measure of the roundness of the face as proxy for overweight

  3 months

Secondary Outcomes (15)

• Change in Heart Systematic COronary Risk Evaluation (SCORE)

  3 months

• Change in HOMA-insulin resistance (IR) index

  3 months

• Change in Fatty Liver Index

  3 months

• Change in FINDRISC score

  3 months

• Change in % skin autofluorescence by MultiSpectral analysis

  3 months

Study Arms (2)

Repeatability and reproducibility study

EXPERIMENTAL

Monitoring of system ("Wize MIrror") measurements with changes in environmental conditions (fasting state, light, temperature)

Other: Wize Mirror

Validation study

EXPERIMENTAL

Longitudinal monitoring of cardiometabolic risk factors through an user---friendly, unobtrusive, personalized system for lifestyle self---management (the "Wize Mirror")

Other: Wize Mirror

Interventions

Wize Mirror OTHER

Interactive mirror which integrates contactless sensors and a touch screen interface to derive a semeiotic model of the face with reference to cardiometabolic risk in healthy subjects

Repeatability and reproducibility study; Validation study

Eligibility Criteria

• Age: 25 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Blood pressure and heart rate measure after 10 minutes lying without treatment: 95 mmHg\<Systolic Blood Pressure\<160 mmHg; 45 mmHg\<Diastolic Blood Pressure\<90 mmHg; 40 bpm\<Heart rate\<100bpm.
• Broad range of CM risk profile
• Interested and willing to change their lifestyle by decreasing body weight and/or increasing physical fitness and/or improving their well-being following medical advice

You may not qualify if:

• History of overt disease, including hypertension, diabetes, dyslipidemia requiring drug treatment
• Chronic medical treatment other than contraception
• Declared pregnancy and breastfeeding
• Claustrophobia
• Minor or adult under guardianship
• Prisoner
• Expected poor compliance
• Subject who has exceeded the maximum foreseen compensation for participation in research protocols

Sponsors & Collaborators

• Istituto di Fisiologia Clinica CNR: lead
• Centre de Recherche en Nutrition Humaine Rhone-Alpe: collaborator

Study Sites (3)

Centre de Recherche en Nutrition Humaine

Lyon, 69310, France

Location

Istituto di Fisiologia Clinica del CNR UOS Milano

Milan, Milano, 20162, Italy

Location

Istituto di Fisiologia Clinica del CNR

Pisa, 56124, Italy

Location

MeSH Terms

Conditions

Obesity; Hypercholesterolemia; Smoking; Motor Activity

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Hyperlipidemias; Dyslipidemias; Lipid Metabolism Disorders; Metabolic Diseases; Behavior

Study Officials

• Maria Aurora Morales, MD

  Istiuto di Fisiologia Clinica del CNR Pisa

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 9, 2016
• First Posted: June 29, 2016
• Study Start: July 1, 2016
• Primary Completion: October 1, 2016
• Study Completion: October 1, 2016
• Last Updated: November 4, 2016

Record last verified: 2016-11

Data Sharing

• IPD Sharing: Will not share

Locations

IT (2); FR (1)