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 @ 7:04 PM
Ignite Modification Date:
2025-12-24 @ 7:04 PM
NCT ID:
NCT06520657
Eligibility Criteria:
Inclusion Criteria:
* Family must have one major social risk factor on the Protocol for Responding to \& Assessing Patients' Assets, Risks \& Experiences (PRAPARE) of the 14 modifiable risk factors
* Child aged 8 through 12 years of age
* Child with BMI% at 85th percentile or higher and less than the 120% of the 95th percentile (overweight or class 1 obesity)
* Child must live with parent/guardian at least 5 out of the 7 days on average (70% of the time)
* Child and parent able to speak English
Exclusion Criteria:
* Child on medications known to cause ongoing weight gain (e.g., atypical anti-psychotics, chronic prednisone, insulin)
* Child on other medications know to affect weight if dose and BMI z-score has not been stable for 3 months.
* Diabetes or other disease that has a significant effect on diet, physical activity, or ability to take part in trial activities besides obesity (does not included treated or mild depression or anxiety, limited food allergies or mild physical activity limitations)
* For parents: new MI, stroke or cancer diagnosis (excluding localized skin cancers) in past 6 months, history of bariatric surgery within the past 3 years, pregnancy in last 6 months or planned within 1 year
* Child or parent has significant developmental or cognitive impairments or other significant medical issue that would interfere with ability to participate or complete assessment
* Parent or child has significant physical limitation
* Parent/child planning to move to from Children's Mercy Kansas City (CMKC) service area
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
8 Years
Study:
NCT06520657
Study Brief:
Protocol Section:
NCT06520657