MedTrace Logo

DEMETRA - ADVICE-002-2022

NCT05394779 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 246

Last updated 2024-11-06

No results posted yet for this study

Summary

The purpose of this study is to evaluate the safety and performance of DTXO App in improving weight loss and weight-loss maintenance in obese patients exposed to an experimental non-pharmacological treatment program. The App will include a dietary plan and customized advice program, a customized physical exercise program plan, a cognitive- behavioral assessment and support program, alerts and reminders on prescribed drugs intake and on dietary and exercise program, chat and online visits with clinical professionals, and trophies to improve patient engagement.

Conditions

  • Obesity
  • Health Behavior
  • Life Style
  • Dietary Habits
  • Weight Loss
  • Diet, Healthy
  • Diet Habit
  • Body Weight
  • Nutrition Disorders
  • Nutrition, Healthy
  • Overweight and Obesity
  • Behavioral Disorder

Interventions

DEVICE

DTXO APP

DTXO is an investigational therapeutic intervention (Digital Therapeutics - DTx) for obese patients, under clinical validation with a randomized and placebo-controlled clinical trial for confirmatory purposes. It 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. The App integrates different non-pharmacological approaches, engaging the patient through monitoring of her/his non-vital parameters, monitoring of patient diet and exercise, monitoring of patient psychological status, prescription of exercise and diet in a weight-loss program.

DEVICE

PLACEBO APP - Control group

The placebo App will include only the non-medical modules of the digital therapy and has been introduced to make the experience of subjects in the control arm more similar to that of subjects in the experimental arm; moreover, data collection through the placebo app (questionnaires) will streamline the data collection process, avoiding manual data entry and reducing the possibility of entry errors.

Sponsors & Collaborators

  • Advice Pharma Group srl

    lead INDUSTRY

Principal Investigators

  • Alessandro Flavio Ferri · Advice Pharma Grou S.r.l

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-08-23
Primary Completion
2023-12-18
Completion
2024-05-30

Countries

  • Italy

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05394779 on ClinicalTrials.gov