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 @ 1:46 AM
Ignite Modification Date:
2025-12-25 @ 1:46 AM
NCT ID:
NCT05424094
Eligibility Criteria:
Inclusion Criteria:
1. girls/boys aged 7-17 years.
2. participation with children
3. age-adjusted BMI: P \> 97th percentile or 90th-97th percentile + diseases whose prognosis is worsened by the overweight or are the result of the overweight
4. medical examination unobjectionable
5. motivation to participate in the programme is given
6. written informed consent of the participant, 6.1. for children up to 14 years of age, verbal consent of the child is sufficient, plus written consent of the parents or a legal representative 6.2. for adolescents aged 14 and over, written consent from the adolescent is sufficient.
Exclusion Criteria:
1. BMI \< 90 percentile
2. not part of 'easy for children
3. medical examination questionable
4. no motivation to participate in the programme
5. no verbal and/or written consent of the children and their parents/legal representatives
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
7 Years
Maximum Age:
17 Years
Study:
NCT05424094
Study Brief:
Protocol Section:
NCT05424094