E66.00 Obesity due to excess calories Grade 1 obesity (WHO) in patients aged 18 and over E66.01 Obesity due to excess calories Grade 2 obesity (WHO) in patients aged 18 and over
Conditions
Interventions
Group 1: Intervention group (IG): Participants receive the treatment program zanadio (class 1 medical device) over a period of 12 months.
Group 2: Control group (CG): Participants in the control grou
Sponsors
aidhere GmbH
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: Participants are people between 18 and 65 years of age with a BMI between 30 and 40 kg/m2.
Exclusion criteria
Exclusion criteria: 1) severe comorbidities, lack of physical fitness or physical limitations that do not allow moderate independent physical activity 2) acute untreated or unstable mental disorders (diagnosed disorders or problems, significant stress or restrictions therapeutic treatment or psychotropic medication), 3) condition after bariatric surgery 4) Presence of secondary forms of obesity, such as Cushing's syndrome, Prader-Willi syndrome, hypothyroidism or hypogonadism. 5) Study participants should be able to speak and write German fluently 6) Own a mobile device 7) Pregnant subjects 8) Persons who are not able to give their informed consent
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percentage in body weight loss after 9 months relative to baseline weight. | — |
Secondary
| Measure | Time frame |
|---|---|
| Reduction of the 1) waist-to-hip ratio and waist-to-height ratio (waist and hip circumference in cm with a measuring tape) and improvement in 2) well-being (WHO-Five) as well as 3) quality of life (WHOQOL-BREF questionnaire) after 9 months compare to baseline. | — |
Countries
Germany
Contacts
Public ContactLena Roth
Universität Leipzig Medizinische Fakultät c/o Max-Planck-Institut für Kognitions- und Neurowissenschaften
Outcome results
None listed