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iAmHealthy Clinical Practice Guideline (CPG)

NCT ID: NCT06888011

Last Updated: 2025-12-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

1024 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-09-06

Study Completion Date

2028-11-30

Brief Summary

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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).

Detailed Description

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Obesity poses a major health risk, contributing to elevated morbidity and mortality from cancer, cardiovascular disease, and diabetes. Children living in rural areas have higher rates of obesity than their urban counterparts. Based upon our extensive prior work, the investigators propose a multilevel factorial design randomized controlled trial with interventions at the clinic and individual patient level to treat pediatric obesity among underserved rural children and families. The individual intervention is an mHealth rurally tailored pediatric obesity behavioral intervention (iAmHealthy) vs. Newsletter control while the clinic level intervention is a cluster randomized stepped wedge (Healthy Clinic intervention) designed to improve clinics' treatment of children with overweight and obesity. 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. The Healthy Clinic intervention is designed to improve provider office processes using a bundled intervention of provider prompts, skills training and intervention tools implemented with performance feedback targeted at the implementation of the American Academy of Pediatrics 2023 Clinical Practice Guideline. This study will be the first to assess both clinic level and patient level pediatric obesity interventions tailored to the unique barriers in rural pediatric populations. Four states (KS, NE, OK, SC), who are members of the ECHO IDeA State Pediatric Clinical Trials Network (ISPCTN) and participated in a previous feasibility study of the iAmHealthy intervention (NCT04142034) in rural medical clinics have each recruited four medical clinics who care for rural children. In each rural clinic, investigators will recruit up to 64 caregiver/child dyads who will be randomly assigned to iAmHealthy or Newsletter, for a total of 512 child/caregiver dyads. The current proposal studies two easily disseminable multilevel interventions and their combination to address modifiable risk factors for cancer in rural populations, specifically pediatric obesity. These findings could significantly change the way medical clinics care for the 41% of rural children who are overweight or obese.

Conditions

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Pediatric Obesity Rural Health Clinical Practice Guideline

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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 Clinic).
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Participants: iAmHealthy

Intervention Type 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

Families will receive a monthly newsletter for six months.

Group Type ACTIVE_COMPARATOR

Participants: Newsletter

Intervention Type BEHAVIORAL

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

Clinics: Healthy Clinics

Healthy Clinics is a clinic level intervention designed to improve provider office processes using a bundled intervention of provider prompts, skills training and intervention tools implemented with performance feedback. Clinics are randomized to the order in which they undertake the individually randomized iAmHealthy vs. Newsletter intervention and the cluster randomized Healthy Clinic intervention

Group Type OTHER

Participants: iAmHealthy

Intervention Type 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

Intervention Type BEHAVIORAL

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

Clinics: Healthy Clinics

Intervention Type OTHER

Healthy Clinics is a clinic level intervention designed to improve provider office processes using a bundled intervention of provider prompts, skills training and intervention tools implemented with performance feedback. Each clinic receives Healthy Clinics at some point in the intervention.

Interventions

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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.

Intervention Type BEHAVIORAL

Participants: Newsletter

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

Intervention Type BEHAVIORAL

Clinics: Healthy Clinics

Healthy Clinics is a clinic level intervention designed to improve provider office processes using a bundled intervention of provider prompts, skills training and intervention tools implemented with performance feedback. Each clinic receives Healthy Clinics at some point in the intervention.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* 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


* 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

* 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


* Unable to generate lists of children seen in clinic by date of visit, age, and zip code
Minimum Eligible Age

6 Years

Maximum Eligible Age

11 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Institute of Nursing Research (NINR)

NIH

Sponsor Role collaborator

University of Kansas Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Ann Davis, PhD, MPH, ABPP

Role: PRINCIPAL_INVESTIGATOR

University of Kansas Medical Center

Paul M Darden, MD

Role: PRINCIPAL_INVESTIGATOR

The University Of Oklahoma Health Sciences Center

Locations

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University of Kansas Medical Center

Kansas City, Kansas, United States

Site Status RECRUITING

University of Nebraska Medical Center

Omaha, Nebraska, United States

Site Status RECRUITING

University Of Oklahoma Health Sciences Center

Oklahoma City, Oklahoma, United States

Site Status RECRUITING

Medical University of South Carolina

Charleston, South Carolina, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Ann M Davis, PhD, MPH, ABPP

Role: CONTACT

Phone: 913-588-6323

Email: [email protected]

Megan Olalde, MS, RD

Role: CONTACT

Phone: 913-588-2042

Email: [email protected]

Facility Contacts

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Ann M Davis, PhD, MPH, ABPP

Role: primary

Megan Olalde, MS, RD

Role: backup

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

Role: primary

Samantha Beisel

Role: backup

Paul M Darden, MS

Role: primary

James R Roberts, MD, MPH

Role: primary

Shannon Cabaniss, MPH

Role: backup

Other Identifiers

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STUDY00160797

Identifier Type: -

Identifier Source: org_study_id

R01NR021278

Identifier Type: NIH

Identifier Source: secondary_id

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