E66.04 E66.05 E66.94 E66.95
Conditions
Interventions
Group 1: Control:
Participants enter a prospective observation phase for three months without using the digital health application. During this phase, regular medical care continues unchanged in accor
Sponsors
Medigreif Digital Health GmbH
Eligibility
Sex/Gender
All
Age
13 Years to 18 Years
Inclusion criteria
Inclusion criteria: - Clinically diagnosed obesity in accordance with WHO/IOTF standards, corresponding to ICD-10: E66.04, E66.05, E66.94, or E66.95 - BMI = 95th percentile (age- and gender-specific) - Possession of an internet-enabled smartphone (Android or iOS) - Ability to operate the device in accordance with the requirements of the study protocol - Motivation and willingness to useban app to support the management of the obesity condition - Willingness to participate in the study, adhere to the study protocol, and complete study-related questionnaires - Ability to independently and context-appropriately implement exercise and dietary recommendations - Provision of a signed written informed consent form by the participant as well as their legal guardians - Sufficient cognitive ability to understand the objectives, requirements, and potential risks of the study - Sufficient proficiency in German to actively participate and understand the study content
Exclusion criteria
Exclusion criteria: - Current use of another digital health application (DiGA) for the treatment of obesity - Use of a corresponding health-related DiGA within the last 3 months - Participation in a structured weight-reduction program during study participation - Presence of medical conditions or circumstances that, in the physician's discretion, impair the ability to adhere to the study protocol, or that pose an additional risk or significant burden due to study participation, such as: - Pregnancy or breastfeeding at the time of recruitment or during the planned study duration - Medical conditions that preclude exercise therapy, e.g., severe obesity with impaired mobility, overt cardiovascular insufficiency - Psychiatric disorders resulting in significant impairment - Diagnosed eating disorders with significant health-related implications (e.g., bulimia, anorexia) - Celiac disease or other severe food allergies - Severe visual impairment that prevents the safe and reliable use of the digital application, or other functional limitations - Planned change of the treating physician during the study duration, provided that said physician is outside the investigator network and subsequent inclusion is not possible.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoint is the change in the participants' Body Mass Index (BMI) as well as their age- and sex-adjusted BMI z-score. To evaluate the efficacy of the app usage, the change in the BMI z-score during the app usage phase (t2 – t1) will be compared intra-individually with the change during the preceding observation phase (t1 – t0). Data collection will be performed prospectively within the framework of regular outpatient standard care across three consecutive doctor visits (t0, t1, t2). All clinical parameters will be collected by the treating physicians and transmitted to the study center. The BMI as well as the age- and sex-adjusted BMI z-score will be calculated based on the collected anthropometric data and national reference values. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary Endpoints: - Change in waist circumference - Change in waist-to-height ratio Exploratory Endpoints: - Health-related quality of life (using KIDSCREEN-10) - Adherence regarding app usage - App feedback - optional: body fat percentage and blood pressure Data collection will be performed prospectively within the framework of regular outpatient standard care across three consecutive doctor visits (t0, t1, t2). All clinical parameters will be collected by the treating physicians and transmitted to the study center. Patient-reported outcomes (quality of life, health behavior, adherence, and app feedback) will be collected using standardized questionnaires. Assessment occurs at defined time points prior to the start of app usage and upon completion of the app usage phase. | — |
Countries
Germany
Contacts
Public ContactKerstin Rebrin
Institut für Diabetes Karlsburg GmbH
Outcome results
None listed