iAmHealthy: family mobile program to help rural children with overweight or obesity

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

The study uses a multilevel factorial randomized controlled design with randomization at both the clinic level (a cluster randomized stepped-wedge Healthy Clinic intervention versus control periods) and the individual level (iAmHealthy versus newsletter). The iAmHealthy intervention is a rurally tailored, family-based behavioral program delivered via mHealth that provides about 26 contact hours of group and individual sessions. The Healthy Clinic intervention is a site-level quality improvement bundle including provider prompts, skills training, office tools, and performance feedback to support implementation of the American Academy of Pediatrics 2023 Clinical Practice Guideline. The trial enrolls children ages 6–11 with BMI ≥85th percentile who live in rural areas and allows English- or Spanish-speaking families to participate.

Why it matters

Who can join: the full rules

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

Where it's running

• University of Kansas Medical Center
  Kansas City, Kansas, United States Recruiting
• University of Nebraska Medical Center
  Omaha, Nebraska, United States Recruiting
• University Of Oklahoma Health Sciences Center
  Oklahoma City, Oklahoma, United States Recruiting
• Medical University of South Carolina
  Charleston, South Carolina, United States Recruiting

Study contacts

• Principal investigator: Ann Davis, PhD, MPH, ABPP — University of Kansas Medical Center
• Study coordinator: Ann M Davis, PhD, MPH, ABPP
• Email: adavis6@kumc.edu
• Phone: 913-588-6323

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.