Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 1:11 AM
Ignite Modification Date:
2025-12-25 @ 1:11 AM
NCT ID:
NCT06665893
Eligibility Criteria:
Inclusion Criteria:
* Age \>6.0 and \<16.0 years of age at inclusion
* Obesity according to International Obesity Task Force (IOTF)
* Willingness to participate in an obesity treatment proof of concept trial
* Family ability to communicate e.g. write and read messages in the mobile application
* Parents having a smart phone and an email address
Exclusion Criteria:
* Morbid obesity defined as iso-BMI\>40 kg/m2 independently of age
* Endocrine disorders other than well controlled hypothyroidism
* Metabolic disorders of importance for weight control
* Treatment for depression and other psychiatric disorders during the last 6 months before inclusion
* Pharmacological treatment of importance for weight control
* Hypothalamic or monogenic obesity, e.g. syndromes and Mb Down
* Severe neuropsychiatric disorders that could affect study compliance
* Eating disorders requiring therapy during the last six months before inclusion or observed at the inclusion screening.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
6 Years
Maximum Age:
16 Years
Study:
NCT06665893
Study Brief:
Protocol Section:
NCT06665893