iAmHealthy Clinical Practice Guideline (CPG)

Not Applicable

Not yet recruiting

• Conditions: Pediatric Obesity; Rural Health; Clinical Practice Guideline

• Registration Number: NCT06888011
• Lead Sponsor: University of Kansas Medical Center

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).

Detailed Description

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 32 caregiver/child dyads who will be randomly assigned to iAmHealthy (n=16) or Newsletter (n=16), 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.

Study Timeline

• Study First Submitted: 2025-02-21
• Status Verified: 2025-03
• Study First Submitted QC: 2025-03-19
• Last Update Submitted: 2025-03-19
• Study First Posted: 2025-03-21
• Last Update Posted: 2025-03-21
• Study Start: 2025-05
• Primary Completion: 2028-11
• Study Completion: 2028-11

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 1024

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
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 audit	Every 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.

Secondary Outcome Measures

Name	Time	Method
Change from baseline to 6 months to year 4 in child physical activity using the Exercise Vital Sign	Baseline, 6 months, year 4	The Exercise Vital Sign (EVS) is a modification of the Behavioral Risk Factor Surveillance System (BRFSS) Physical Activity (PA) questions, and its development was supported by PA experts as part of the Exercise is Medicine effort in the United States. EVS assesses the average time spent exercising by multiplying responses on 2 self-reported questions. Responses are multiplied to display minutes per day of moderate or strenuous exercise.
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	The "moderate to vigorous physical activity" screening measure is a 2-item parent reported measure.
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	The PROMIS Parent Proxy Physical Activity Measure will measure how often parents report in the past 7 days that their child engaged in various physical activity.
Change from baseline to 6 months to year 4 in child dietary behavior	Baseline, 6 months, year 4	Child dietary behavior will be assessed with the Children's Eating Habits Questionnaire food frequency section (CEHQ-FFQ). The CEHQ-FFQ was designed to estimate the eating behaviors and intakes for each of the major food groups related to general health status and childhood obesity. A conversion factor is used to transform child dietary intake and fast-food consumption into weekly consumption frequencies, ranging from 0 to 25 and 0 to 8, respectively.
Change from baseline to 6 months to year 4 in child sleep	Baseline, 6 months, year 4	Child sleep will be assessed with the Children's Sleep Habits Questionnaire (CSHQ). This 22-item questionnaire has 9 questions about bedtime, 7 questions about sleep behavior, 2 questions about waking at night, and 4 questions about morning wake up. The measure results in a score of overall sleep quality, with scores over 41 indicating sleep problems.
Parent and child satisfaction of intervention and technology	6 months	The child satisfaction measure was developed specifically for the current study and will shadow the parent satisfaction items. Specific to technology, the investigators will also administer the 12-item Parent-Reported Satisfaction Measure, assessing three technology-related satisfaction domains: technical, comfort with technology and perceived privacy, and access.
Change from baseline to 6 months to year 4 in caregiver body mass index (BMI)	Baseline, 6 months, year 4	Height and weight will be collected remotely and used to calculate BMI.
Clinic: Internal clinic chart audit	Every month for 6 months	As a measure of interim progress in the Healthy Clinic intervention, clinic staff will conduct monthly audits of their own patient medical records for child BMI and BMI%ile, evidence of recognition of whether the patient has overweight/obesity, plan for addressing overweight/obesity, and counseling for diet and activity. Each audit will include 10 of the most recently seen patients 6-11 years of age who have overweight or obesity. Additional items will be added to assess the individual clinics' ongoing QI process. This will occur only while clinics are in the Healthy Clinics Intervention.

Trial Locations

Locations (4)

University of Kansas Medical Center; 🇺🇸 Kansas City, Kansas, United States

University of Nebraska Medical Center; 🇺🇸 Omaha, Nebraska, United States

University Of Oklahoma Health Sciences Center; 🇺🇸 Oklahoma City, Oklahoma, United States

Medical University of South Carolina; 🇺🇸 Charleston, South Carolina, United States