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 @ 12:02 AM
Ignite Modification Date:
2025-12-25 @ 12:02 AM
NCT ID:
NCT04618458
Eligibility Criteria:
Inclusion Criteria:
* AA parents (biological, grandparent, legal guardian) and their 8- to 11-year-old child residing in the same home.
* One overweight/obese parent (BMI ≥25 kg/m2) and child (≥ 85th% age-/sex-specific BMI).
* Parent at-risk for diabetes (American Diabetes Association risk test) AND HbA1c 5.7% - 6.4%.
Exclusion Criteria:
* child or parent has a history of T2DM or a screening HbA1c \>6.4%;
* is taking glucose-lowering medications;
* is participating in a supervised weight loss program;
* is pregnant or breast feeding;
* has conditions limiting participation;
* has undergone weight loss surgery;
* is moving out-of-state within 6 months.
* If a parent becomes pregnant during the study, we will include only child data (index participant) in analyses
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
8 Years
Maximum Age:
11 Years
Study:
NCT04618458
Study Brief:
Protocol Section:
NCT04618458