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RecruitingNot applicable

iAmHealthy Clinical Practice Guideline (CPG)

Implementation of the New Pediatric Obesity Clinical Practice Guideline in Rural Families and Clinics: A Randomized Clinical Trial

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
6 Years to 11 Years
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests the Healthy Clinic program at clinics and compares the iAmHealthy program with a newsletter for children. It is for children ages 6–11 who live in rural areas and have a body mass index (BMI), a measure of weight compared with height, at or above the 85th percentile.

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).

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Children must be ages 6–11 when they agree to join.
  • Children must have a BMI at or above the 85th percentile, meaning it is as high as or higher than that of 85 out of 100 children of the same age and sex.
  • Children must live in a rural area.
  • The child and family must speak English or Spanish.
  • Clinics must have worked with the study site's award recipient on research or projects to improve care.
  • Clinics must have had at least 300 children who could qualify for the study in the past year.
  • Clinics must use electronic medical records.

Who can't join

  • Children cannot join if a physical limitation or injury greatly limits movement, or if planned medical care during the study will do so.
  • Children cannot join if they have a known health problem, such as cancer, that could make it hard to follow study rules.
  • Children cannot join if they or their main caregiver have delays in development or problems with thinking or learning that could make it hard to follow study rules.
  • Children cannot join if they are in another weight-loss study.
  • Children cannot join if a sibling has already agreed to join this study.
  • Clinics cannot join if they cannot make lists of children by visit date, age, and ZIP code.

Simplified for readability. The official criteria below are what the study team uses.

Official 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

Study sites (4)

KS

NE

OK

SC