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 @ 3:30 PM
Ignite Modification Date:
2025-12-24 @ 3:30 PM
NCT ID:
NCT05935592
Eligibility Criteria:
Inclusion Criteria (child):
* self-identifies as Black/African-American and/or Latino
* between ages 8 and 12 years (preadolescents) at time of scheduled baseline visits
* reads and speaks in English
* has a Body Mass Index percentile at or above 5% at baseline (categorized as healthy, overweight, or obese)
* has regular internet access via a tablet device, smartphone, or computer/laptop
* has regular access to a phone with texting capability
* is comfortable reading/viewing material on electronic devices
* is comfortable speaking with study staff about thoughts/experiences while participating in study
* has a legal parent/guardian willing to participate in study
Inclusion Criteria (parent):
* legal parent/guardian of child willing to participate in study
* reads and speaks in English or Spanish
* primarily responsible for preparing/purchasing food for child
* has regular internet access via a tablet device, smartphone, or computer/laptop
* has regular access to a phone with texting capability
* comfortable reading/viewing material on electronic devices
* able to attend in-person study visits and complete online questionnaires with their child over the full duration of study
Exclusion Criteria (child):
* has allergies, food aversions, food disorders, or medications with side-effects that may impact participation in study
* has a pacemaker or heart condition
* in foster care
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
8 Years
Maximum Age:
12 Years
Study:
NCT05935592
Study Brief:
Protocol Section:
NCT05935592