NCT06888011

iAmHealthy Clinical Practice Guideline (CPG)

Implementation of the New Pediatric Obesity Clinical Practice Guideline in Rural Families and Clinics: A Randomized Clinical Trial

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 1,024 (estimated)
• Sponsor: University of Kansas Medical Center · Academic / Other
• Sex: All
• Age: 6 Years – 11 Years
• Healthy volunteers: Not accepted

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 their urban counterparts. Based upon our extensive prior work, the investigators propose a multilevel factorial design randomized controlled trial with interventions at the clinic and individual patient level to treat pediatric obesity among underserved rural children and families. The individual intervention is an mHealth rurally tailored pediatric obesity behavioral intervention (iAmHealthy) vs. Newsletter control while the clinic-level intervention is a cluster randomized stepped wedge (Healthy Clinic intervention) designed to improve clinics' treatment of children with overweight and obesity. The iAmHealthy intervention is a rurally tailored empirically supported family-based behavioral group program targeting the families of children who are overweight or obese and providing 26 contact hours of group and individual intervention. The Healthy Clinic intervention is designed to improve provider office processes using a bundled intervention of provider prompts, skills training and intervention tools implemented with performance feedback targeted at the implementation of the American Academy of Pediatrics 2023 Clinical Practice Guideline. This intervention is a site-level quality improvement implementation, not a participant-facing intervention. This study will be the first to assess both clinic level and patient level pediatric obesity interventions tailored to the unique barriers in rural pediatric populations. Four states (KS, NE, OK, SC), who are members of the ECHO IDeA State Pediatric Clinical Trials Network (ISPCTN) and participated in a previous feasibility study of the iAmHealthy intervention (NCT04142034) in rural medical clinics have each recruited four medical clinics who care for rural children. In each rural clinic, investigators will recruit up to 64 caregiver/child dyads who will be randomly assigned to iAmHealthy or Newsletter, for a total of 512 child/caregiver dyads. The current proposal studies two easily disseminable multilevel interventions and their combination to address modifiable risk factors for cancer in rural populations, specifically pediatric obesity. These findings could significantly change the way medical clinics care for the 41% of rural children who are overweight or obese.

Conditions

• Pediatric Obesity
• Rural Health
• Clinical Practice Guideline

Interventions

Type	Name	Description
BEHAVIORAL	Participants: iAmHealthy	Families will take part in an educational group program with parents and their children. These one-hour meetings will be focused on living healthy lifestyles and engaging in healthy habits as a family and will occur weekly for three months and monthly for three months. Each family will also have the opportunity to receive individual health coaching sessions every other week that will last approximately 30 minutes to address concerns and health behaviors specific to each pair. There will be additional opportunities to demonstrate and apply learned concepts.
BEHAVIORAL	Participants: Newsletter	Families assigned to the newsletter control intervention will receive the AAP Healthy Children Newsletter (HealthyChildren.org) every month for six months.

Timeline

• Start date: 2025-09-02
• Primary completion: 2028-11-01
• Completion: 2028-11-01
• First posted: 2025-03-21
• Last updated: 2026-04-13

Locations

4 sites across 1 country: United States