Status:
COMPLETED
DEMETRA - ADVICE-002-2022
Lead Sponsor:
Advice Pharma Group srl
Conditions:
Obesity
Health Behavior
Eligibility:
All Genders
18-65 years
Phase:
NA
Brief 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 tr...
Detailed Description
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 change...
Eligibility Criteria
Inclusion
- Participants must be between 18 and 65 years of age, at the time of signing the informed consent.
- Male and Female.
- Capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and this protocol.
- BMI between 30.0 kg/m2 and 45 kg/m2 .
- Participants must own a mobile phone, be willing to use mobile Apps and this type of technology (technology-savvy) and download the App described in the protocol.
- Native speakers of Italian language or foreign subjects who have a full understanding of the Italian language, as the instructions and information for all health programs will only be given in Italian.
Exclusion
- Heart failure (class \>II), ischemic attack or stroke within the previous 6 months to the planned date of randomization.
- History or current evidence of drug or alcohol abuse.
- Chronic kidney failure with GFR category \>G2 (ml/min/1.73 m2).
- Type 1 diabetes.
- Previous malignancy within the first 5 years.
- Active eating disorder or previous history of bulimia and anorexia nervosa, active severe binge-eating disorder.
- Psychiatric disorders not compensated or at risk of decompensation.
- Visual or vision impairments
- Secondary obesity related to endocrinopathies, genetic syndromes, hypothalamic lesions or neurological diseases and immobility.
- Concomitant advanced obesity disease.
- History of bariatric surgery in the previous 2 years or plans for bariatric surgery during the study period.
- Referred pain to lower limb joints (hip, knee, ankle) on the NRS ≥ 5.
- Weight loss ≥10% in the 6 months prior to the planned date of randomization.
Key Trial Info
Start Date :
August 23 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 30 2024
Estimated Enrollment :
246 Patients enrolled
Trial Details
Trial ID
NCT05394779
Start Date
August 23 2022
End Date
May 30 2024
Last Update
November 6 2024
Active Locations (1)
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1
Istituto Auxologico Italiano
Milan, Italy, 20145