RecruitingNot ApplicableNCT06888011

iAmHealthy Clinical Practice Guideline (CPG)

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


Sponsor

University of Kansas Medical Center

Enrollment

1,024 participants

Start Date

Sep 6, 2025

Study Type

INTERVENTIONAL

Conditions

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).


Eligibility

Min Age: 6 YearsMax Age: 11 Years

Inclusion Criteria7

  • 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
  • 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 Criteria6

  • 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
  • Unable to generate lists of children seen in clinic by date of visit, age, and zip code

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Interventions

BEHAVIORALParticipants: 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.

BEHAVIORALParticipants: Newsletter

Families assigned to the newsletter control intervention will receive the AAP Healthy Children Newsletter (HealthyChildren.org) every month for six months.

OTHERClinics: Healthy Clinics

Healthy Clinics is a clinic level intervention designed to improve provider office processes using a bundled intervention of provider prompts, skills training and intervention tools implemented with performance feedback. Each clinic receives Healthy Clinics at some point in the intervention.


Locations(4)

University of Kansas Medical Center

Kansas City, Kansas, United States

University of Nebraska Medical Center

Omaha, Nebraska, United States

University Of Oklahoma Health Sciences Center

Oklahoma City, Oklahoma, United States

Medical University of South Carolina

Charleston, South Carolina, United States

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NCT06888011


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