iAmHealthy: family mobile program to help rural children with overweight or obesity
Implementation of the New Pediatric Obesity Clinical Practice Guideline in Rural Families and Clinics: A Randomized Clinical Trial
This tests a family-focused mobile health program called iAmHealthy against a newsletter for rural children ages 6–11 with overweight or obesity while clinics receive a Healthy Clinic program to improve care.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 1024 (estimated) |
| Ages | 6 Years to 11 Years |
| Sex | All |
| Sponsor | University of Kansas Medical Center Academic / other |
| Locations | 4 sites (Kansas City, Kansas and 3 other locations) |
| Trial ID | NCT06888011 on ClinicalTrials.gov |
What this trial studies
The study uses a multilevel factorial randomized controlled design with randomization at both the clinic level (a cluster randomized stepped-wedge Healthy Clinic intervention versus control periods) and the individual level (iAmHealthy versus newsletter). The iAmHealthy intervention is a rurally tailored, family-based behavioral program delivered via mHealth that provides about 26 contact hours of group and individual sessions. The Healthy Clinic intervention is a site-level quality improvement bundle including provider prompts, skills training, office tools, and performance feedback to support implementation of the American Academy of Pediatrics 2023 Clinical Practice Guideline. The trial enrolls children ages 6–11 with BMI ≥85th percentile who live in rural areas and allows English- or Spanish-speaking families to participate.
Who should consider this trial
Good fit: Ideal candidates are children ages 6–11 with BMI at or above the 85th percentile who live in rural areas and whose families speak English or Spanish and can engage with a mobile-based program.
Not a fit: Children with major medical or mobility-limiting conditions, cognitive impairments that affect participation, those already enrolled in another weight-loss trial, or non-rural residents are unlikely to receive benefit from this intervention.
Why it matters
Potential benefit: If successful, participants could have healthier weight trajectories and clinics in rural areas could deliver better guideline-based obesity care.
How similar studies have performed: Family-based behavioral programs and mHealth approaches have shown benefit for pediatric obesity, but pairing a rurally tailored iAmHealthy program with a clinic-level implementation of the 2023 AAP guideline represents a novel multilevel approach.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Kansas City, Kansas and 3 other locations
- University of Kansas Medical Center — Kansas City, Kansas, United States (Recruiting)
- University of Nebraska Medical Center — Omaha, Nebraska, United States (Recruiting)
- University Of Oklahoma Health Sciences Center — Oklahoma City, Oklahoma, United States (Recruiting)
- Medical University of South Carolina — Charleston, South Carolina, United States (Recruiting)
Study contacts
- Principal investigator: Ann Davis, PhD, MPH, ABPP — University of Kansas Medical Center
- Study coordinator: Ann M Davis, PhD, MPH, ABPP
- Email: adavis6@kumc.edu
- Phone: 913-588-6323
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.