NCT05394779Completed
DEMETRA - ADVICE-002-2022
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
Source: ClinicalTrials.gov · Last updated 6 Nov 2024
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 246 (actual)
- First submitted
- 5 May 2022
- Start date
- 23 Aug 2022
- Primary completion date
- 18 Dec 2023
- Lead sponsor
- Advice Pharma Group srl
- Diseases
- Obesity
- NCT number
- NCT05394779
What you commit to
- Study type: Interventional
- Participants enrolled: 246
- From 23 Aug 2022 to the primary completion date, 18 Dec 2023
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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.
Other illness
- 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.
Lab values
- Chronic kidney failure with GFR category \>G2 (ml/min/1.73 m2).
Other
- Visual or vision impairments
- Referred pain to lower limb joints (hip, knee, ankle) on the NRS ≥ 5.
Who the study is looking for
- 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.
Age in the registry: 18 years to 65 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Istituto Auxologico Italiano Coordinator of this site? Confirm its status | Milan | Italy | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.