DEMETRA - ADVICE-002-2022

Korábbi kezelés

• 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.
• Active eating disorder or previous history of bulimia and anorexia nervosa, active severe binge-eating disorder.
• Concomitant advanced obesity disease.
• History of bariatric surgery in the previous 2 years or plans for bariatric surgery during the study period.
• Weight loss ≥10% in the 6 months prior to the planned date of randomization.

Más betegség

• Type 1 diabetes.
• Previous malignancy within the first 5 years.
• Psychiatric disorders not compensated or at risk of decompensation.
• Secondary obesity related to endocrinopathies, genetic syndromes, hypothalamic lesions or neurological diseases and immobility.

Laborértékek

• Chronic kidney failure with GFR category >G2 (ml/min/1.73 m2).

Egyéb

• Visual or vision impairments
• Referred pain to lower limb joints (hip, knee, ankle) on the NRS ≥ 5.

• 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.