Actively Recruiting
Implementation of the New Pediatric Obesity Clinical Practice Guideline in Rural Families and Clinics: A Randomized Clinical Trial
Led by University of Kansas Medical Center · Updated on 2026-04-13
1024
Participants Needed
4
Research Sites
N/A
Total Duration
On this page
Sponsors
U
University of Kansas Medical Center
Lead Sponsor
N
National Institute of Nursing Research (NINR)
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are conducting a randomized controlled trial to study pediatric obesity among children living in rural areas, where obesity rates are higher than in urban settings. This trial evaluates two interventions: one at the clinic level called the Healthy Clinic intervention, which aims to improve how clinics treat children with overweight or obesity by using provider prompts, skills training, and tools; and another at the individual patient level, comparing a rurally tailored behavioral program called iAmHealthy to a monthly newsletter control. The study focuses on underserved rural children and families and aims to address modifiable risk factors for cancer related to obesity. The iAmHealthy program is a family-based behavioral group intervention offering 26 contact hours over six months, including weekly one-hour group meetings for the first three months, monthly meetings for the next three months, and biweekly individual health coaching sessions lasting about 30 minutes. Families assigned to the control group receive the American Academy of Pediatrics Healthy Children Newsletter monthly for six months. The clinic-level intervention is implemented as a quality improvement program at the site level, not directly involving participants. Participants in this study include children aged 6 to 11 years with a BMI at or above the 85th percentile living in rural areas. Caregiver/child pairs are assessed at baseline, six months, and annually up to four years. Researchers will track changes in child and caregiver body mass index, physical activity using multiple measures, dietary behavior, sleep, and satisfaction with the intervention and technology. Clinic performance will be monitored through chart audits every month for six months and then every six months for 3.5 years. The total participation period extends up to four years, with detailed follow-up assessments during this time.
CONDITIONS
Brief Title
iAmHealthy Clinical Practice Guideline (CPG)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Child is ages 6-11 years at consent
- Child BMI percentile is 85th or higher
- Child lives in a rural area
- Child and family speak English or Spanish
- Clinic has a history of collaboration with the study team
- Clinic has at least 300 eligible children in the past year
- Clinic uses an electronic medical records system
You will not qualify if you...
- Child has a physical limitation or injury that substantially limits physical mobility or plans medical treatment limiting mobility during the trial
- Child has a medical condition that could affect following the study protocol, such as cancer
- Child or primary caregiver has developmental delay or cognitive impairment affecting protocol compliance
- Child is enrolled in another weight-loss trial
- Child has a sibling already participating in the trial
- Clinic cannot generate lists of children by visit date, age, and zip code
AI-Screening
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Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - 6 months
Participants take part in either the iAmHealthy behavioral intervention including weekly group sessions for three months, monthly group sessions for three months, and individual health coaching every other week; or receive monthly newsletters for six months.
Weekly visits for 3 months, then monthly visits for 3 months, plus biweekly individual coaching sessions for those in the iAmHealthy group; monthly contact for those receiving newsletters
Duration - Up to 4 years after baseline
Participants are monitored for changes in child and caregiver health outcomes including body mass index, physical activity, dietary behavior, and sleep up to four years after baseline.
Visits at baseline, 6 months, and annually up to 4 years
Trial Site Locations
Total: 4 locations
1
University of Kansas Medical Center
Kansas City, Kansas, United States, 66160
Actively Recruiting
2
University of Nebraska Medical Center
Omaha, Nebraska, United States, 68198
Actively Recruiting
3
University Of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, United States, 73104
Actively Recruiting
4
Medical University of South Carolina
Charleston, South Carolina, United States, 29425
Actively Recruiting
Research Team
A
Ann M Davis, PhD, MPH, ABPP
M
Megan Olalde, MS, RD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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