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 @ 10:52 PM
Ignite Modification Date:
2025-12-24 @ 10:52 PM
NCT ID:
NCT05586269
Eligibility Criteria:
Child Inclusion Criteria:
* Children \>=6 years and \<12 years old with a BMI \>=95th percentile
* Children who screen positive on the 2-item Hunger Vital Sign™
* Children living in a household of \<=5 people
* Children living with an English and/or Spanish-speaking caregiver
* Children living within the EatWell delivery map boundaries in the greater Boston area
Child Exclusion Criteria:
* History of food allergies or intolerance to dairy, gluten, soy, or any potential component of the meal kit
* History of malabsorptive intestinal disease (e.g., Crohn's disease, celiac disease)
* History of type 1 or 2 diabetes
* History of solid tumor or bone marrow transplant
* Enteral tube dependence
The child's primary caregiver will be eligible for enrollment.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
6 Years
Study:
NCT05586269
Study Brief:
Protocol Section:
NCT05586269