iAmHealthy Clinical Practice Guideline (CPG)

NCT06888011 | Recruiting DMC

• 2 other identifiers: STUDY00160797R01NR021278
• Study Type: interventional
• Target: 1,024
• Locations: 1 country
• Sites: 4

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

Outcome Measures

Primary Outcomes (2)

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

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

  Baseline, 6 months, year 4

• Clinic: Independent clinic chart audit

  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.

  Every six months for 3.5 years

Secondary Outcomes (8)

• Change from baseline to 6 months to year 4 in child physical activity using the Exercise Vital Sign

  Baseline, 6 months, year 4

• Change from baseline to 6 months to year 4 in child physical activity using the "moderate to vigorous physical activity" screening measure

  Baseline, 6 months, year 4

• Change from baseline to 6 months to year 4 in child physical activity using the PROMIS Parent Proxy Physical Activity Measure

  Baseline, 6 months, year 4

• Change from baseline to 6 months to year 4 in child dietary behavior

  Baseline, 6 months, year 4

• Change from baseline to 6 months to year 4 in child sleep

  Baseline, 6 months, year 4

Other Outcomes (4)

• Child/caregiver demographics and medical history/update

  Baseline, 6 months, year 4

• Clinic: Qualitative interviews

  Year 4

• Clinic: Questionnaires for quality improvement

  Years 1 and 4

Study Arms (2)

Participants: iAmHealthy

EXPERIMENTAL

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.

Behavioral: Participants: iAmHealthy

Participants: Newsletter

ACTIVE COMPARATOR

Families will receive a monthly newsletter for six months.

Behavioral: Participants: Newsletter

Interventions

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: iAmHealthy

Participants: Newsletter BEHAVIORAL

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

Participants: Newsletter

Eligibility Criteria

• Age: 6 Years - 11 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

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 may not qualify 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
• 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
• Unable to generate lists of children seen in clinic by date of visit, age, and zip code

Sponsors & Collaborators

• University of Kansas Medical Center: lead
• National Institute of Nursing Research (NINR): collaborator

Study Sites (4)

University of Kansas Medical Center

Kansas City, Kansas, 66160, United States

RECRUITING

University of Nebraska Medical Center

Omaha, Nebraska, 68198, United States

RECRUITING

University Of Oklahoma Health Sciences Center

Oklahoma City, Oklahoma, 73104, United States

RECRUITING

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

RECRUITING

MeSH Terms

Conditions

Pediatric Obesity

Condition Hierarchy (Ancestors)

Obesity; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Ann Davis, PhD, MPH, ABPP

  University of Kansas Medical Center

  PRINCIPAL INVESTIGATOR

• Paul M Darden, MD

  The University Of Oklahoma Health Sciences Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ann M Davis, PhD, MPH, ABPP

CONTACT

913-588-6323; adavis6@kumc.edu

Megan Olalde, MS, RD

CONTACT

913-588-2042; molalde@kumc.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: The study is a multilevel factorial individually and cluster randomized stepped wedge design RCT with interventions targeted to the individual patient level (iAmHealthy vs. Newsletter) and to the clinic (Healthy Clinics). Healthy Clinics is a site-level quality improvement implementation to support providers and workflow, not a participant-facing intervention.

Study Record Dates

• First Submitted: February 21, 2025
• First Posted: March 21, 2025
• Study Start: September 2, 2025
• Primary Completion (Estimated): November 1, 2028
• Study Completion (Estimated): November 1, 2028
• Last Updated: April 13, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (4)