Evaluation of Performance and Safety of DTXO App, an Innovative Digital Therapy, in Improving Weight Loss and Weight-Loss Maintenance of Patients with Obesity by Increasing Their Adherence to Dietary, Exercise Regimens and Psycho-Behavioral Program

DTXO is a medical device designed to deliver digital therapy intervention (DTx) to patients. The DT, as part of Digital Health, utilizes high quality digital technologies to stimulate lifestyle changes in patients. DTXO has been set up to improve the commitment of patients in following therapeutic directives (i.e. nutritional programs, daily/weekly physical activities) to manage the disease of obesity. Moreover, DTXO can improve patient's awareness about patients disease (obesity) so is intended to improve weight loss, weight-loss maintenance, and overall health in patients with obesity by increasing their self-engagement, self-monitoring and adherence to dietary/exercise and behavioral programs. In this prospective, multicenter, pragmatic, randomized, double-arm placebo-controlled, parallel, single-blind study, the App integrates different non-pharmacological approaches, engaging the patient through monitoring of patients non-vital parameters, monitoring of patient diet and exercise, monitoring of patient psychological status, prescription of exercise and diet in a weight-loss program, and configurable data presentation charts for provision of additional information to professional users.

The aim of this study is to monitor patients' non-vital parameters through data collection through patient-reported information, data collection through coupled devices, data processing by a proprietary algorithm based on clinical guidelines and data visualization by a proprietary interface; AND Prescribe diet, exercise and psycho-behavioral support intended for weight loss in obese patients.

The dietary will be a personalized hypocaloric Mediterranean-based dietary program according to sex, ages must be between 18 and 65 years of age, physical activity level, dietary preferences and eating habits and prescribed by the nutritionist physician at baseline (V0), which aims at decreasing weight in obese patients and favoring patients' compliance and adherence to the diet. And regardless of the randomization arm, all patients enrolled in the study will be invited by the investigator to follow a dietary program with a daily caloric intake (kilocalories/day or kcal/day) assigned by a standardized method with a fixed caloric deficit equal to 800 kcal drawn on the suggested values range from 500 to 1000 kcal.

Specifically, the caloric intake is classified starting from the measure of the daily Basal Metabolic Rate (BMR) based on genders (male, female), weight, height and age measured at baseline (V0).

The study will enroll 246 subjects, both genders to obtain 172 overall valuable subjects (86 for each group). The recruitment period will last 4 months. Each patient will be followed for 12 months after baseline, during which lifestyle changes will be implemented with/without DTXO. Regular follow-up visits are foreseen at 3 months ±15 days (V1), 6 months ±15 days (V2), 9 months ±15 days (V3) and 12 months ±15 days (V4) after enrollment, in the end of the study is defined as the date of the last scheduled procedure shown in the Schedule of Activities for the last participant in the study globally.