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:
2025-12-24 @ 4:15 PM
Ignite Modification Date:
2025-12-24 @ 4:15 PM
NCT ID:
NCT01254266
Eligibility Criteria:
Inclusion Criteria:
1. BMI \> 40, with a physical complication known to improve by weight reduction or BMI \> 95% for age and weight with a serious obesity-related physical complication that without intervention would require acute invasive procedure.
2. Previous failures in obtaining weight reduction in the framework of intensive, outpatient programs.
3. Voluntary participation by the child and his or her family and high motivation for change as assessed in a pre-hospitalization assessment.
Exclusion Criteria:
1. Failure of parents in applying changes required by the program (e.g., missing parent guidance appointments).
2. Lack of cooperation with the program (e.g., non-compliance with dietary regime, failure in maintaining food diaries).
3. Failure to obtain weight reduction in two consecutive weeks, without a clear physical or medical cause.
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Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
10 Years
Maximum Age:
18 Years
Study:
NCT01254266
Study Brief:
Protocol Section:
NCT01254266