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Implementation of the New Pediatric Obesity Clinical Practice Guideline in Rural Families and Clinics: A Randomized Clinical Trial
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).
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 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.
Age
6 - 11 years
Sex
ALL
Healthy Volunteers
No
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
Start Date
September 6, 2025
Primary Completion Date
November 1, 2028
Completion Date
November 1, 2028
Last Updated
December 22, 2025
1,024
ESTIMATED participants
Participants: iAmHealthy
BEHAVIORAL
Participants: Newsletter
BEHAVIORAL
Clinics: Healthy Clinics
OTHER
Lead Sponsor
University of Kansas Medical Center
Collaborators
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
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