E66
Conditions
Interventions
Group 1: Intervention group: Intervention with “Oviva Direkt für Adipositas” for 48 weeks
Group 2: Control group: Standard of care for 24 weeks followed by intervention with “Oviva Direkt für Adiposit
Sponsors
Oviva AG
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: - BMI 30-45 kg/m² - Confirmed diagnosis of obesity (according to ICD-10 E66) - Own smartphone with a compatible operating system for the „Oviva Direkt” app - Written informed consent - Living in Germany - Good understanding of German Language (at least B2 level or equivalent)
Exclusion criteria
Exclusion criteria: - Expected poor compliance / adherence to study procedures - Incapacity to consent - Persons in a dependent / employment relationship with the Sponsor or investigator - Cognitive incapacity impeding participation and study compliance - Participation in another clinical examination for weight reduction in obesity - Participation in a structured multimodal weight loss programme within the last 6 months or plan to do so in the next 12 months - Previous or current use of Oviva Direkt or participation in other Oviva programmes - Use of another smartphone app for weight reduction in obesity within the last 6 months or plan to do so in the next 12 months - Vigorous weight fluctuations (> 5 kg) in the last 3 months Recent use of obesity / weight management medications, including those used for glycaemic control (in past 6 months); or planned drug treatment for overweight - Bariatric surgery (post or planned) - Planned absence (e.g. vacation, hospitalisation) for more than 3 weeks during the following 6 months - Planned long-term travel of more than 3 weeks during the first 6 months of study participation - Planned surgery during the trial - Restricted mobility or immobility (resulting in an inability to perform moderate movement as specified in the intervention) - Planned cessation of smoking during study period - Inability to use the app - Related persons who use Oviva Direkt or participate in the study (family members, in partnership, same household) Medical conditions (self-reported): - Diabetes mellitus Type 1 - Established cardiovascular disease, severe liver and/or respiratory disease, renal failure - Active cancer (or in remission for <2 years) - Inflammatory bowel disease - Severe chronic infections and/or inflammatory diseases - Severe mental-health disorders - Neurodegenerative disorders - Rare genetic conditions associated with overweight - Endocrine diseases - Eating disorders - Pregnancy and lactation (or planned pregnancy within the next 6 months) - A pacemaker, leading to a restriction in activity - Taking new medication that will influence weight or planning to do so - Drug-induced obesity - Any medical contraindication to losing weight - Drug or alcohol dependency - Morbid (severe) obesity with alveolar hypoventilation
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Weight loss expressed as percent change in body weight after 24 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| a) Weight loss expressed as percent change in body weight after 48 weeks compared to baseline b) Change in health-related quality of life after 24 weeks compared to baseline | — |
Countries
Germany
Outcome results
None listed