Recruiting

iAmHealthy & Newsletter

Sponsor:

University of Kansas Medical Center

Code:

NCT06888011

Conditions

Pediatric Obesity

Rural Health

Clinical Practice Guideline

Eligibility Criteria

Sex: All

Age: 6 - 11

Healthy Volunteers: Not accepted

Interventions

Participants: iAmHealthy

Participants: Newsletter

Study Details

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).

Conditions

Pediatric Obesity

Rural Health

Clinical Practice Guideline

Study ID

NCT06888011

Start date

Sep 2, 2025

Status verified date

Apr, 2026

Completion date

Nov, 2028

Anticipated

Primary completion date

Nov, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 6 - 11

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

1024 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Participants: iAmHealthy

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 over six months.

active comparator: Participants: Newsletter

Families will receive a monthly newsletter for six months.

Interventions

Participants: iAmHealthy

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

Families assigned to the newsletter control intervention will receive the AAP Healthy Children Newsletter (HealthyChildren.org) every month for six months.

Primary outcome measure

  • Change from baseline to 6 months to year 4 in child body mass index (BMI) [ Time Frame: Baseline, 6 months, year 4 ]
  • Clinic: Independent clinic chart audit [ Time Frame: Every six months for 3.5 years ]

Central Contacts and Locations

Central contacts

Ann M Davis, PhD, MPH, ABPP

913-588-6323adavis6@kumc.edu

Megan Olalde, MS, RD

913-588-2042molalde@kumc.edu

Locations

University of Kansas Medical Center

Recruiting

Kansas City, Kansas, United States, 66160

Contacts

Ann M Davis, PhD, MPH, ABPP

913-588-6323adavis6@kumc.edu

Megan Olalde, MS, RD

913-588-2042molalde@kumc.edu

Principal Investigator:

Ann M Davis, PhD, MPH, ABPP

University of Nebraska Medical Center

Recruiting

Omaha, Nebraska, United States, 68198

Contacts

Ellen (El) K Kerns, PhD, MPH, CPH

(402) 955-6038ellen.kerns@unmc.edu

Samantha Beisel

sbeisel@unmc.edu

Principal Investigator:

Ellen (El) K Kerns, PhD, MPH, CPH

University Of Oklahoma Health Sciences Center

Recruiting

Oklahoma City, Oklahoma, United States, 73104

Contacts

Paul M Darden, MS

405-637-5997paul-darden@ouhsc.edu

Principal Investigator:

Paul M Darden, MD

Medical University of South Carolina

Recruiting

Charleston, South Carolina, United States, 29425

Contacts

James R Roberts, MD, MPH

843-876-8512robertsj@musc.edu

Shannon Cabaniss, MPH

smw207@musc.edu

Principal Investigator:

James R Roberts, MD, MPH

More Information

Sponsor

University of Kansas Medical Center

Last update posted

Apr 13, 2026

Last verified

Apr, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Kansas Medical Center on 2026-04-13.