Randomised controlled trial to evaluate the App-based Multimodal Obesity-management programme Oviva Direkt für Adipositas” - AMODA
- Conditions
- E66Obesity
- Registration Number
- DRKS00033045
- Lead Sponsor
- Oviva AG
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 164
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)
- 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
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Weight loss expressed as percent change in body weight after 24 weeks
- Secondary Outcome Measures
Name Time Method a) Weight loss expressed as percent change in body weight after 48 weeks <br>compared to baseline<br>b) Change in health-related quality of life after 24 weeks compared to baseline