E66
Conditions
Interventions
Group 1: Standard 12-week, app-based, multimodal lifestyle intervention using the DiGA Oviva Direkt für Adipositas as prescribed in routine care
Sponsors
Oviva AG
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Possession of a valid activation code for Oviva Direkt für Adipositas 2. Access to a compatible smartphone with the app activated 3. Patient confirmation not to change weight loss medication status during study participation (for either patient group taking no medication or taking medication) 4. Motivation and ability to change lifestyle 5. Availability for the 12-week intervention period (no planned absence >3 weeks) 6. Availability for the data collections in the 24-week study period 7. Not currently pregnant or planning pregnancy during the study period 8. Sufficient proficiency in the German language to understand study materials and questionnaires 9. Provided electronic informed consent
Exclusion criteria
Exclusion criteria: 1. Patients not meeting all inclusion criteria. 2. Inability to provide informed consent.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary Endpoints (week 12 change scores) - Patient Sovereignty (Patient Activation Measure, PAM-13) - Nutrition Literacy (Nutrition Health Literacy Scale, NHLS) - Health-Related Quality of Life (PROMIS-10) | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary Endpoints (week 24 change scores) - Patient Sovereignty (Patient Activation Measure, PAM-13) - Nutrition Literacy (Nutrition Health Literacy Scale, NHLS) - Health-Related Quality of Life (PROMIS-10) Secondary Endpoints (week 12 and 24 change scores) - Medication Adherence - Cardiovascular risk - Health-economic outcome | — |
Countries
Germany
Contacts
Public ContactMarco Lehmann
Oviva AG
Outcome results
None listed