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 @ 5:15 PM
Ignite Modification Date:
2025-12-24 @ 5:15 PM
NCT ID:
NCT07162350
Eligibility Criteria:
Inclusion Criteria:
* between the ages of 8-15 years,
* BMI \> 85th percentile, and
* be seen at one of the selected Parkland COPC (Community Oriented Primary Care) clinics.
* Both the participant and caregiver must be fluent in English or Spanish (read, write, and speak) and be willing to participate in the study over a 12-month duration.
Exclusion Criteria:
* has seen a dietitian within the last year,
* presence of an intellectual disability,
* diagnosed with autism with severe feeding difficulties,
* past medical history of severe feeding difficulties over the age of 2 years,
* has had bariatric surgery
* is taking a GLP-1
* diagnosed with type 1 diabetes
* is taking anti-psychotics
* has severe food allergies
* has a severe psychiatric disorder
* has a disease that would not allow the individual to change their diet, and
* any other reason the PIs deem someone ineligible.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
8 Years
Maximum Age:
15 Years
Study:
NCT07162350
Study Brief:
Protocol Section:
NCT07162350