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 @ 1:05 PM
Ignite Modification Date:
2025-12-24 @ 1:05 PM
NCT ID:
NCT03147261
Eligibility Criteria:
Inclusion Criteria:
1\. Signed informed consent by the child, parent or guardian. 3. waist circumference above the 90th percentile 4. Motivation and willingness to be assigned to either group, and do their utmost to follow protocol assigned.
5\. Possibility of involvement in days of intensive phase (week 0, 1, 2, 3, 4, 5, 6, 7 and 8) and once a month until 6 months later at 4 months and every 6 months during the second year.
Exclusion Criteria:
1. Pre-Diabetes
2. Presence of other diseases
3. Pharmacotherapy
4. Monitoring special diets
5. Food intolerance
6. Regular alcohol consumption
7. Drug
8. Psychiatric illness or eating disorder
9. People without telephone or Internet access
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
7 Years
Maximum Age:
16 Years
Study:
NCT03147261
Study Brief:
Protocol Section:
NCT03147261