What this study is
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).
What's being tested
- Participants: iAmHealthy
Intervention · BEHAVIORAL
Families will take part in an educational group program with parents and their children. These one-hour meetings will be focused on living healthy lifestyles and engaging in healthy habits as a family and will occur weekly for three months and monthly for three months. Each family will also have the opportunity to receive individual health coaching sessions every other week that will last approximately 30 minutes to address concerns and health behaviors specific to each pair. There will be additional opportunities to demonstrate and apply learned concepts.
- Participants: Newsletter
Intervention · BEHAVIORAL
Families assigned to the newsletter control intervention will receive the AAP Healthy Children Newsletter (HealthyChildren.org) every month for six months.
- Clinics: Healthy Clinics
Intervention · OTHER
Healthy Clinics is a clinic level intervention designed to improve provider office processes using a bundled intervention of provider prompts, skills training and intervention tools implemented with performance feedback. Each clinic receives Healthy Clinics at some point in the intervention.
Study details
- Official title
- Implementation of the New Pediatric Obesity Clinical Practice Guideline in Rural Families and Clinics: A Randomized Clinical Trial
- Sponsor
- University of Kansas Medical Center
- Conditions
- Pediatric Obesity · Rural Health · Clinical Practice Guideline
- Enrolling
- 1,024 people
- Starts
- 2025-09-06
- Est. completion
- 2028-11
- Design
- Open-label, randomized, parallel groups
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 6 Years – 11 YearsSex ALLHealthy volunteers Not acceptedindividual participants
You may qualify if
- 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
You can't join if
- 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
clinics
You may qualify if
- 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
You can't join if
- Unable to generate lists of children seen in clinic by date of visit, age, and zip code
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (4)
4 openUniversity of Kansas Medical Center
Kansas City, Kansas, United States
- Ann M Davis, PhD, MPH, ABPP · Contact913-588-6323adavis6@kumc.edu
- Megan Olalde, MS, RD · Contact913-588-2042molalde@kumc.edu
- Ann M Davis, PhD, MPH, ABPP · Principal investigator
RecruitingUniversity of Nebraska Medical Center
Omaha, Nebraska, United States
- Ellen (El) K Kerns, PhD, MPH, CPH · Contact(402) 955-6038ellen.kerns@unmc.edu
- Samantha Beisel · Contactsbeisel@unmc.edu
- Ellen (El) K Kerns, PhD, MPH, CPH · Principal investigator
RecruitingUniversity Of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, United States
- Paul M Darden, MS · Contact405-637-5997paul-darden@ouhsc.edu
- Paul M Darden, MD · Principal investigator
- Amanda L Bogie, MD, FAAP · Sub-investigator
RecruitingMedical University of South Carolina
Charleston, South Carolina, United States
- James R Roberts, MD, MPH · Contact843-876-8512robertsj@musc.edu
- Shannon Cabaniss, MPH · Contactsmw207@musc.edu
- James R Roberts, MD, MPH · Principal investigator
Recruiting
Study team
Sponsor
University of Kansas Medical Center
Study ID STUDY00160797
Principal investigator
Ann Davis, PhD, MPH, ABPP
University of Kansas Medical Center
Principal investigator
Paul M Darden, MD
The University Of Oklahoma Health Sciences Center
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.