E66
Conditions
Interventions
Group 1: Intervention group: The intervention group will receive the Lifeness app as an add-on to care-of-usual for 48 weeks.
Group 2: Control group: Subjects in the control group receive informative
Sponsors
Lifeness AS
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: - Confirmed diagnosis of obesity with BMI =30 and <40kg/m2 • 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 - Individuals who are capable of giving their consent - Smartphone owned and physical as well as psychological and cognitive abilities to use the smartphone - Internet access for the app application and questionnaire response - Motivation to use the app regularly - Email address for registration - Willingness to participate in the collection of data - Possession of an own scale for weight measurement - Sufficient knowledge of the German language
Exclusion criteria
Exclusion criteria: - Secondary obesity due to known endocrine or neurological disorders - Severe physical comorbidities, physical limitations or other medical conditions that do not allow moderate independent physical activity - History of severe psychiatric illness with suicide attempt - Currently diagnosed severe psychiatric illness with considerable strain or limitations in everyday life due to mental illness or mental problems - Currently ongoing psychotherapeutic treatment - Pregnancy or breast feeding or planned pregnancy within the next 12 months - History of surgical or minimally invasive weight reduction procedure or planned procedure within the interventional period - Current usage of the Lifeness App or comparable digital or non-digital weight management programs or usage of such in the last 3 months and = 3% weight loss in the last 3 months - Started with medication that affects weight within the last 3 month or planned use in the next 12 months (e.g., weight loss medication (e.g., semaglutide), specific insulin, specific antidepressant drugs) - Contraindications of the medical device • Current pregnancy • Presence of secondary forms of obesity (Cushing syndrome, Prader-Willi syndrome, hypogonadism, etc.) • Presence of hypothyroidism if not treated with medication in advance • Lack of change resources
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| Change after 48 weeks compared to baseline values: - improvement in the health-related quality of life (WHOQOL-BREF, EQ-5D-5L) - improvement of well-being (WHO-5) - improvement in patient autonomy (PAM13-D) - reduction of internalized weight stigma (WSSQ) - reduction of body fat distribution (waist-to-hip ratio) - reduction of BMI | — |
Primary
| Measure | Time frame |
|---|---|
| Reduction in weight after 48 weeks relative to the baseline weight | — |
Countries
Germany
Contacts
Public ContactSameer Kulkarni
Klinische Forschung Berlin-Mitte GmbH
Outcome results
None listed