Digital multimodal weight loss program - Randomized controlled evaluation of a digital health application for individuals with obesity
- Conditions
- E66Obesity
- Registration Number
- DRKS00033906
- Lead Sponsor
- ifeness AS
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 248
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
- 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
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Reduction in weight after 48 weeks relative to the baseline weight
- Secondary Outcome Measures
Name Time Method Change after 48 weeks compared to baseline values:<br>- improvement in the health-related quality of life (WHOQOL-BREF, EQ-5D-5L)<br>- improvement of well-being (WHO-5)<br>- improvement in patient autonomy (PAM13-D)<br>- reduction of internalized weight stigma (WSSQ)<br>- reduction of body fat distribution (waist-to-hip ratio)<br>- reduction of BMI