Clinical trial

iAmHealthy Clinical Practice Guideline (CPG)

Recruiting now · Not applicable · 1 countries · Registry ID NCT06888011

Recruiting nowNot applicableInterventional

What this study is about

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).

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age6 Years to 11 Years

SexAll

Healthy volunteersNot accepted

ConditionPediatric Obesity, Rural Health, Clinical Practice Guideline

Full registry 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

Treatments and study arms

Participants: iAmHealthy

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

Behavioral

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

Primary outcomes

Change from baseline to 6 months to year 4 in child body mass index (BMI)Baseline, 6 months, year 4

Height and weight will be collected remotely and used to calculate BMI, BMIz, BMI%ile and BMI%95th%ile.

Clinic: Independent clinic chart auditEvery six months for 3.5 years

The primary outcome measure for the Healthy Clinics intervention will be a random audit of 40 medical records in each clinic every 6 months performed by highly trained research staff in each state who are fully independent of the participating medical clinic. The medical record, index visit and latest well visit (within that 6 months), will be audited for child BMI and BMI%ile, evidence of recognition of whether the patient has overweight/obesity, plan for addressing overweight/obesity, followup plan, and counseling for diet and activity. The purpose of the clinic chart audit is to assess the clinic's current activities around identification and treatment of overweight and obesity.