Clinical trial NCT06888011: iAmHealthy Clinical Practice Guideline (CPG)
Official title: Implementation of the New Pediatric Obesity Clinical Practice Guideline in Rural Families and Clinics: A Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Pediatric Obesity
Rural Health
Clinical Practice Guideline
Lead sponsor: University of Kansas Medical Center
Sponsor class: OTHER
Collaborators: name: National Institute of Nursing Research (NINR)
First posted: 2025-03-21
Enrollment: 1024
Sex: ALL
Minimum age (years): 6
Maximum age (years): 11
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The study is a multilevel factorial individually and cluster randomized stepped wedge design RCT with interventions targeted to the individual patient level (iAmHealthy vs. Newsletter) and to the clinic (Healthy Clinic).
Primary purpose: TREATMENT

Brief 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 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 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. 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.

Eligibility 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

Primary outcomes:
measure: Change from baseline to 6 months to year 4 in child body mass index (BMI)
timeFrame: Baseline, 6 months, year 4
measure: Clinic: Independent clinic chart audit
timeFrame: Every six months for 3.5 years
Secondary outcomes:
measure: Change from baseline to 6 months to year 4 in child physical activity using the Exercise Vital Sign
timeFrame: Baseline, 6 months, year 4
measure: Change from baseline to 6 months to year 4 in child physical activity using the "moderate to vigorous physical activity" screening measure
timeFrame: Baseline, 6 months, year 4
measure: Change from baseline to 6 months to year 4 in child physical activity using the PROMIS Parent Proxy Physical Activity Measure
timeFrame: Baseline, 6 months, year 4
measure: Change from baseline to 6 months to year 4 in child dietary behavior
timeFrame: Baseline, 6 months, year 4
measure: Change from baseline to 6 months to year 4 in child sleep
timeFrame: Baseline, 6 months, year 4
measure: Parent and child satisfaction of intervention and technology
timeFrame: 6 months
measure: Change from baseline to 6 months to year 4 in caregiver body mass index (BMI)
timeFrame: Baseline, 6 months, year 4
measure: Clinic: Internal clinic chart audit
timeFrame: Every month for 6 months
Other outcomes:
measure: Child/caregiver demographics and medical history/update
timeFrame: Baseline, 6 months, year 4
measure: Clinic: Qualitative interviews
timeFrame: Year 4
measure: Clinic: Questionnaires for quality improvement
timeFrame: Years 1 and 4
measure: Clinic: Questionnaires for current policies/procedures
timeFrame: Years 1 and 4
Locations:
city: Kansas City
country: United States
facility: University of Kansas Medical Center
state: Kansas
city: Omaha
country: United States
facility: University of Nebraska Medical Center
state: Nebraska
city: Oklahoma City
country: United States
facility: University Of Oklahoma Health Sciences Center
state: Oklahoma
city: Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
Study officials:
affiliation: University of Kansas Medical Center
name: Ann Davis, PhD, MPH, ABPP
role: PRINCIPAL_INVESTIGATOR
affiliation: The University Of Oklahoma Health Sciences Center
name: Paul M Darden, MD
role: PRINCIPAL_INVESTIGATOR
References: