Status:
RECRUITING
iAmHealthy Clinical Practice Guideline (CPG)
Lead Sponsor:
University of Kansas Medical Center
Collaborating Sponsors:
National Institute of Nursing Research (NINR)
Conditions:
Pediatric Obesity
Rural Health
Eligibility:
All Genders
6-11 years
Phase:
NA
Brief Summary
The current study is a multilevel factorial design RCT with interventions at the clinic (Healthy Clinic intervention period vs. Control period) and individual patient levels (iAmHealthy vs. Newsletter...
Detailed Description
Obesity poses a major health risk, contributing to elevated morbidity and mortality from cancer, cardiovascular disease, and diabetes. Children living in rural areas have higher rates of obesity than ...
Eligibility Criteria
Inclusion
- Inclusion criteria for individual participants:
- Child is ages 6-11 years at consent
- Child BMI %ile is ≥85th
- Child lives in a rural area
- Child/family speaks English or Spanish
- Exclusion criteria for individual participants:
- Child has a physical limitation or injury that substantially limits physical mobility or has a planned medical treatment during the course of the trial that will substantially limit physical mobility
- Child has a known medical issue that could affect protocol compliance (e.g., cancer)
- Child and/or primary caregiver has a developmental delay or cognitive impairment that could affect protocol compliance
- Child is enrolled in a weight-loss trial
- Child has a sibling who has already consented in the trial
- Inclusion criteria for clinics:
- History of collaboration with site awardee in research or quality improvement projects
- In the past year at least 300 eligible potential participants
- The clinic must have an electronic medical records system
- Exclusion criteria for clinics:
- Unable to generate lists of children seen in clinic by date of visit, age, and zip code
Exclusion
Key Trial Info
Start Date :
September 6 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 1 2028
Estimated Enrollment :
1024 Patients enrolled
Trial Details
Trial ID
NCT06888011
Start Date
September 6 2025
End Date
November 1 2028
Last Update
December 22 2025
Active Locations (4)
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1
University of Kansas Medical Center
Kansas City, Kansas, United States, 66160
2
University of Nebraska Medical Center
Omaha, Nebraska, United States, 68198
3
University Of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, United States, 73104
4
Medical University of South Carolina
Charleston, South Carolina, United States, 29425