iAmHealthy Clinical Practice Guideline (CPG)
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Details and patient eligibility
About
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).
Full 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 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.
Enrollment
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Inclusion and 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
Trial design
Primary purpose
Allocation
Interventional model
Masking
1,024 participants in 3 patient groups
Trial contacts and locations
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Central trial contact
Megan Olalde, MS, RD; Ann M Davis, PhD, MPH, ABPP
Data sourced from clinicaltrials.gov
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