DEMETRA - ADVICE-002-2022
Obesity, Health Behavior, Life Style
About this trial
This is an interventional supportive care trial for Obesity focused on measuring Digital Therapeutics, Digital Medicine, Adherence, Software, Software Medical Device, Quality of life, Digital Therapy, Obesity, Exercise Program, Physical Activity, Diet, Nutritional Program, Psychological status
Eligibility Criteria
Inclusion Criteria:
- 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 Criteria:
- 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.
Sites / Locations
- Istituto Auxologico ItalianoRecruiting
Arms of the Study
Arm 1
Arm 2
Experimental
Placebo Comparator
DTXO APP
PLACEBO APP-Control group
Patients randomized to Group A (experimental group) will be administered the Mediterranean based dietary program by means of App DTXO. The dietary program will be administered through the DTXO application. Each patient will select the assigned daily menu or the proposed alternatives; The dietary program is personalized according to the patients caloric intake needs and to their nutritional restrictions. Patients randomized to Group A (experimental group) will be administered the Physical activity program by means of App DTXO. The activity program will be administered through the DTXO application based on the individual's background fitness level. Patients randomized to Group A (experimental group) will be invited to follow a psycho-behavioral program to increase awareness of the behaviors and habits related to obesity, consisting of multimedia and educational content, self-assessment and dynamic exercises.
Patients randomized in Group B (control group) will be delivered a dietary program, according to the current standard of care and will be printed on paper with the information on the Mediterranean diet and general educational content related to food. The control arm will also be equipped with a placebo App to ensure the patient's blindness to treatment allocation and there will be asked to the patient to complete weekly the Diet Adherence questionnaire. Patients randomized in Group B (control group) will be advised to perform regular physical activity and provided with educational material and some tips on physical activity; no formal plan will be provided, as currently done in standard clinical practice. Patients randomized in Group B (control group) will receive printed educational material with generic content and advice for self-help support and followed as per standard clinical practice. The placebo App will be used as a data entry tool for questionnaires.