Implementation of the New Pediatric Obesity Clinical Practice Guideline in Rural Families and Clinics: A Randomized Clinical Trial - PROJECT SUMMARY/ABSTRACT 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, we 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 (AR, KS, NE, 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 32 caregiver/child dyads who will be randomly assigned to iAmHealthy (n=16) or Newsletter (n=16), for a total of 512 child/caregiver dyads. Aim 1 assesses the effectiveness of the iAmHealthy intervention vs Newsletter control with an outcome of a healthier BMI for children. Aim 2 assesses the effectiveness of the Healthy Clinic intervention with the outcome of identification and treatment of children with overweight and obesity. In Aim 3 we compare the effectiveness of the combination of the iAmHealthy intervention and the Healthy Clinic intervention to each individual intervention and to no intervention. 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.
